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See application file for complete search history. a mineral; wherein said first physical state of said ingredient
of said first receiving chamber being different from said sec
(56) References Cited ond physical state of said ingredient of said second receiving
chamber; and said ingredient of said first receiving chamber
U.S. PATENT DOCUMENTS being different from said ingredient of said second receiving
3,072,528 A 1/1963 Kludas et al. chamber.
4,185,740 A 1, 1980 Perfect
4,578,075 A 3/1986 Urquhartet al. 111 Claims, 13 Drawing Sheets
US 7,670.612 B2
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Action for Declaratory Judgment and Breach of Contract. Richardson, M., et al., Filing Two-Piece Hard Gelatin Capsules with
Action for Declaratory Judgment, Breach of Contract and Fraudulent Liquids, Jan 2008.
or Negligent Inducement. Partial translation of JP Utility Model Publication (Kokai) No.
Innercap Technologies, Inc.'s Answer, Affirmative Defenses, and 62-01 1135 A (1987).
Counterclaims to Plaintiff Nutrex Research, Inc.'s Complaint. * cited by examiner
U.S. Patent Mar. 2, 2010 Sheet 1 of 13 US 7,670,612 B2
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US 7,670,612 B2
1. 2
MULTI-PHASE, MULTI-COMPARTMENT may be broadly characterized as a compressed powder or
CAPSULAR DELVERY APPARATUS AND granular solid. Prior to compression of the granular powder
METHODS FOR USING SAME comprising the medicament into tablet form, the presence of
one or more excipients may be required. An excipient
RELATED APPLICATIONS includes any inert Substance (i.e., gum arabic, starch or the
like) combined with a principal ingredient to facilitate the
This Application is a continuation-in-part of PCT/US/03/ preparation of an agreeable or convenient dosage form of the
10816 filed Apr. 9, 2003, and entitled “MULTI-PHASE, active or medicament. Functional characteristics of excipi
MULTI-COMPARTMENT CAPSULAR SYSTEM”, the ents may include, for example, disintegration, lubrication,
contents of which are hereby incorporated by reference in 10 appearance, palatability, shelf-stability or the like.
their entirety. This application incorporates herein by refer Those skilled in the art also developed capsules as a con
ence U.S. Provisional Application Ser. No. 60/371,448, filed trivance for containing a solid or liquid dosage form of a
Apr. 10, 2002, and entitled “INTEGRATED CAPSULE medicament. Traditional capsular embodiments include a
DELIVERY APPARATUS AND METHOD.” This applica first containment section referred to as a base, and a second
tion further claims the benefit of U.S. patent application Ser. 15 containment section referred to as a cap. The two pieces of the
No. 10/369,427, filed Feb. 18, 2003, entitled “MULTI capsule are usually formulated and designed in a manner Such
PHASE, MULTI-COMPARTMENT CAPSULAR DELIV that the material to be encapsulated may be introduced into
ERY APPARATUS AND METHODS FORUSING SAME, the base section, whereas the open end of the cap section may
which is hereby incorporated herein by reference. This appli be correspondingly positioned over the open end of the base.
cation further claims the benefit of U.S. patent application The walls of the cap and base are generally in physical contact
Ser. No. 10/368,951, filed Feb. 18, 2003, entitled “PROCESS with one another to form a single internal cavity. A means for
FOR ENCAPSULATING MULTI-PHASE, MULTI-COM structurally sealing the cap in relation to the base may also be
PARTMENT CAPSULES,” which is hereby incorporated incorporated during manufacture to insure non-tampering of
herein by reference. This application further claims the ben the capsule. In this regard, those skilled in the art developed
efit of U.S. patent application Ser. No. 10/369,244, filed on 25 sealing technology which contemplates banding, heat fusion
Feb. 18, 2003, and entitled “MULTI-PHASE, MULTI-COM (spot-welding) and Snap seals which utilize a "tongue and
PARTMENT CAPSULAR DELIVERY APPARATUS FOR groove' scheme.
THERAPEUTIC COMPOSITIONS AND METHODS FOR The outer walls of a capsule are preferably formed of a
USING SAME.” which is hereby incorpoated herein by ref soluble ingredient, such as, for example, gelatin (animal
erence. This application further claims the benefit of U.S. 30 based product), starch, hydrophillic polymer or hydroxypro
patent application Ser. No. 10/369,247, filed Feb. 18, 2003, pyl methyl-cellulose (HPMC), which provides a barrier for
and entitled “PROCESS FOR ENCAPSULATING MULTI containing the active ingredient or medicament, in powder or
PHASE, MULTI-COMPARTMENT CAPSULES FOR liquid form, within the internal periphery of the capsule walls.
THERAPEUTIC COMPOSITIONS, which is hereby incor Traditionally, hard gelatin capsules may be manufactured by
porated herein by reference. 35 dipping plates of stainless Steel pins into a pool of gelatin
Solution. The pins are then removed from the gelatin and
BACKGROUND rotated while the gelatin is dried in a kiln with forced, humid
ity-controlled air. Once dried, the gelatin capsules are typi
1. The Field of the Invention cally stripped from the pins, trimmed to a Suitable length and
The present invention relates to delivery of active ingredi 40 then joined together (e.g., base and cap) and packaged for
ents or medicaments and, more particularly, to novel capsular production use.
delivery apparatus and methods for delivering one or more With the advent of automated encapsulation machinery,
active ingredients or medicaments having diverse physical the responsibility to produce encapsulated products shifted
states (e.g., Solid, liquid, gas or dispersion) into a single mainly to industrial manufacturers. Contemporaneous with
dosage, multi-compartment capsule. 45 the development of the encapsulation industry, those skilled
The present invention further relates to methods for the in the art have advanced the state of the encapsulation art. For
administration of a plurality of heterogenous chemical and example, several significant improvements in encapsulation
biological compounds to animals and humans using a multi technology have been seen over the last forty years. These
compartment delivery system for treatment of different con technological improvements have included, for example, the
ditions or the same condition or diseases (different or same) in 50 development of soft elastic capsules, film-coating techniques,
one or more organ systems. micro-encapsulation and multiple-compartment technology.
2. Background of the Invention Soft elastic capsules, often referred to as Soft gelatin cap
As appreciated by those skilled in the art, the contempla Sules, were developed in an effort to provide means for encap
tion, design, testing and manufacture of chemicals and bio Sulating liquids and other medicaments which are typically
molecules for administration to humans and animals, as nutri 55 poorly soluble in water. In preferred design, Soft elastic cap
tional ortherapeutic agents, requires a thorough integration of Sules are made from a thicker and more plastic gelatin having
clinically contemplated delivery principles and modalities. an increased flexibility due to the addition of a polyol, such as
Chemicals and biomolecules that may be administered to glycerin or sorbitol. The addition of such plasticizers has been
humans and animals are often referred to herein as “actives.” found, however, to have the potential disadvantage of increas
“active ingredients' or “medicaments.” 60 ing the risk for microbial growth. Thus an antimicrobial. Such
Oral administration has become one of the most frequent as a paraben or Sorbic acid, may be added to the Soft elastic
routes for delivering one or more active ingredients or medi capsule shell in order to address any microbial concern.
caments to the body. Active ingredients or medicaments, such Prior art film-coating techniques generally involve a plat
as nutritional or therapeutic agents, may be orally adminis ing process, whereby a thin, uniform film may be deposited
tered in a variety of physical states (i.e., Solid, liquid or gas). 65 onto the outer surface of the delivery vehicle (e.g., tablet or
Tablets and capsules are generally the most common vehicle capsule). Several Successive layers may be deposited onto the
for the oral delivery of medicaments. As appreciated, a tablet outer surface of the vehicle, if desired, in an effort to facilitate
US 7,670,612 B2
3 4
various desirable properties. For example, Sugar-coating, a spheroid may contain a pH sensitive coat; and the inner spher
precursor to film-coating, has been used by those skilled in oid may include a pH insensitive coat.
the art for more than one hundred years to make tablets more In addition to pH-sensitive coatings, hydrogels and other
palatable. Other advantages or properties offilm-coating may gastric retention technologies have been developed by those
include for example, but not by way of limitation, protection skilled in the art in an effort to retard the progression of the
from moisture, oxidation, controlling microbial contamina delivery vehicle during enteric transit. This retarding action,
tion and inhibiting modification of the chemical properties of presumably, allows the full amount of active medicament to
the active ingredient. As further appreciated by those skilled be released and/or targeted to a specific area of the gas
in the art, prior art film-coating may form an interfacial bar trointestinal tract. Hydrogel and related gastric retention
rier between two chemicals or chemical compounds that 10 devices of the prior art generally rely upon the imbibing of
might otherwise react when they come into contact. water into a center core which is filled with cellulose or
Enteric coatings and Sustained-release formulations are similar water absorbent material. In preferred operation, the
contemplated as variations on prior art film-coating tech material Swells and releases multiple compartments of active
niques. In particular, enteric coating describes a process medicament. The concept of using bulk size to slow transit of
where the delivery vehicle (e.g., tablet or capsule) is coated 15 single active medicament in a single physical state is thus
with one or more layers of chemicals that are somewhat appreciated.
resistant to extreme pH conditions. For example, conditions In an effort to administer active ingredients or medica
of extremely low pH are commonly encounter in the stomach. ments to a specific location in the body to treat a specific
Many active ingredients or medicaments are in the form of a disorder caused by a specific pathogen, those skilled in the art
pharmaeceutical salt and thus highly Susceptible to ionization have used targeted-release systems using multi-compartment
in the presence of hydrogen ions. Thus, the presence of an capsular technology. For example, a method for carrying out
enteric coating generally provides a level of protection as to a triple therapy against the microorganisms Helicobacter
degradation of the active ingredient or medicament until tran pylori, a known infectious agent which is believed largely
sit from the stomach into the Small intestine is accomplished. responsible for the development of gastric ulcer disease, was
Film coatings have also led to the development of delivery 25 developed which comprises the steps of oral administration of
vehicles (e.g., tablets and capsules) having Sustained-release a pharmaeceutical dosage form comprising an internal cap
properties. Mixtures of waxes, cellulose, silicone and similar Sule placed inside an external capsule, wherein the external
resins have been found useful by those skilled in the art for capsule comprises a soluble salt of bismuth and a first anti
creating-Sustained release coatings. In principle, these prior biotic, and the internal capsule comprises a second antibiotic.
art coatings function to delay the release of the active ingre 30 In addition, multi-compartmental capsules were developed
dient or medicament to the targeted body system, thereby which combine a nutrient supplement with a viable direct-fed
facilitating a timed, absorption rate in the body. Furthermore, microbial (i.e., gastrointestinal microorganisms, including
the entire daily dosage of an active or medicament may be bacteria, live cell yeasts, fungi or a combination thereof) for
contained in a single, Sustained-release delivery vehicle (e.g., the purpose of treating livestock for feeding disorders and
tablet or capsule), whereas the immediate absorption of the 35 improving feed efficiency.
entire dosage could possibly lead to an overdosage of the A disadvantage with prior art encapsulation technology is
medicament. Thus, by layering quanta of medicament with when the base and corresponding cap of a capsule are joined,
differential coatings, the dosage undergoes a controlled dead space Volume is typically created within the internal
release over specified time period. The application of Sus periphery of the capsule. Internal capsular dead space may be
tained-release film coating technology therefore may inher 40 filed with an air bubble which may ultimately react with one
ently facilitate the delivery of a total daily dosage amount of or more of the active ingredients or medicaments introduced
an active or medicament to be released to the body in con within the capsule, thereby potentially degrading the quality
trolled increments. and effectiveness of the active ingredients.
Over the last several years, a considerable amount of atten Although the prior art discloses multiple compartment,
tion has been focused on the further development of multi 45 capsular delivery technology, these manifestations generally
compartment capsule technology for the delivery of therapeu includes one of two approaches. For example, one approach
tic and diagnostic agents. Series formulations teach the use of contemplates the introduction of a single active or medica
membranes or other types of barriers to cordon a line of ment into multiple capsular compartments to vary the tempo
separate chambers within a single encapsulating shell. As ral release of the medicament and ultimately the absorption
appreciated, the purpose of such multi-compartment delivery 50 rate into the body. Another approach contemplates the intro
devices is the administration of multiple dosages. Moreover, duction of a plurality of active ingredients or medicaments
multiple-compartment delivery mechanisms of the prior art into different compartments of a single capsule for delivery to
were developed to circumvent or diminish the effects of harsh a specific area of the body to treat a targeted illness or condi
pH environments within humans. For example, the prior art tion.
contemplates a hard capsule formulation which contains 55 The use or contemplation of multiple-compartment capsu
three different compartments of active medicaments for lar delivery apparatus or methods which deliver different
administration to the vaginal and rectal areas. In preferred physical forms of the same active or medicament, or a varia
structure, the formulation outer, rapid-release layer may con tion in physical forms of different actives or medicaments in
tain an active medicament and excipient; the middle, inter a single dosage, however, has not heretofore been contem
mediate-release layer may include a powder form of active 60 plated in the art. As appreciated by those skilled in the art,
medicament; and the inner, slow-release layer may contain active ingredients or medicaments may take the physical form
pellets or granules of active medicament. ofa Solid (e.g., pill, tablet, capsule (both hard and Soft elastic),
Also taught in the prior art are multi-compartment capsules powder, granulation, flakes, troches (lozenges and pastilles),
having groups of spheroids with pH-dependent coatings Suppositories and semi-solid ointments, pastes, emulsions
which are encapsulated within a hard gelatin shell and pro 65 and creams), a liquid (e.g., Solution, spirits, elixir, syrups,
vided for treating female yeast infection. The first spheroid is sprays and fluid extracts), a gas or a dispersion. A dispersion
preferably uncoated and may be in a powderform; the second is a system in which a dispersed phase is distributed through
US 7,670,612 B2
5 6
a continuous phase (e.g., aerosols (liquid or Solid in gas), usage in a single dosage form. The present invention, in
Suspensions (Solid in liquid), emulsion (liquid in liquid), overcoming the shortcomings of the prior art, satisfies these
foam (gas in liquid), Solid foam (Solid in gas) or gel (liquid or and other objectives.
Solid in Solid)). Dispersions can be classified as molecular, The art and practice of pharmacy can be divided into four
colloidal and coarse, depending on size. In many circum 5 distinct divisions. Pharmacology is the study of interactions
stances, however, the different physical forms or phases of occurring between the pharmacologic agent, or medicament
more than one active ingredient or medicament may not be and specific targeted cells in the body. More specifically, the
suitably combined or mixed together without altering the interaction between an active agent and a cellular receptor
individual desirable properties of the active ingredient or along with the resulting change in cell physiology is exam
medicament. For example, although it would be possible and 10 ined. Medicinal chemistry is largely concerned with the iden
desirable to formulate a dispersion by combining a first active tification of naturally occurring and synthetic compounds
ingredient in the Solid State with a second active ingredient which possess medicinal characteristics.
that exists as a liquid, adverse chemical interactions between Pharmacotherapeutics is the holistic application of phar
the active ingredients may adversely affect various character macy practice to specific pathologies, illnesses, and other
istics of the ingredients, including but not limited to, their 15 body functions. Finally, Pharmaceutical Science ascertains or
shelf lives. The resulting chemical decomposition—and the regulates the composition of medicinal Substances, and is
potential formation of any unwanted side products—could largely directed to the development of new mechanisms for
result in diminished drug potency or eventoxicity to a patient. delivering chemicals and biomolecules into animals and
Additionally, the physical properties of crystalline active humans. A Subcategory of pharmaceutical Science is called
ingredients could be drastically altered in scenarios where it pharmacokinetics and sometimes generally referred to as
is desirable to co-administer a crystalline active ingredient biopharmaceutics.
with a liquid or semi-liquid different active ingredient. In this A.D.M.E. is an acronym often used to describe the four
context, the control of physical properties such as active essential components to pharmaceutical Science: absorption,
ingredient dissolution rate and solubility is often a critical distribution, metabolism, and elimination, respectively. One
factor in determining the overall bioavailability of the active 25 way to differentiate between pharmacology and pharmaceu
ingredient. It is well established in the art that different poly tical science is that the former is primarily concerned with the
morphs or Solvates of the same crystalline active ingredient effect of the medicament on the body, whereas, the latter is
exhibit dramatically different solubility and dissolution rates. primarily concerned with the delivery and time-course of the
Thus, combining a crystalline active agent with a liquid or medicament on its journey through the body.
semi-liquid active agent could give rise to an equilibrium 30 In clinical applications, chemicals and biomolecules are
between concentrations of different polymorphs and/or sol often referred to as active ingredients or medicaments. Medi
vates of the crystalline active ingredient, and thereby frustrate caments may include “pharmaceuticals, nutraceuticals, bio
efforts at tailoring an active ingredient mixture to its intended technicals, vitamins, minerals and dietary Supplements. Oral
purpose as a medicament. administration is the most frequent route for delivery of medi
Another shortcoming with co-administering plural active
35 caments. Medicaments may be orally administered in a vari
ety of physical States, including, Solid, liquid, dispersion, and
ingredients in different physical forms in an intimate mixture gaseous forms. As appreciated, tablets and capsules are the
is the potential for adverse in vivo drug-drug interactions most common vehicle for oral delivery of medicaments.
upon administration. The desire to co-administer these active Frequently, a medical or Surgical patient may receive a
ingredients would be offset by the one active ingredient, for 40 plurality of concurrent medicaments. Data has been accumu
example as in a liquid or semi-liquid (e.g., a paste, Solution, or lated to demonstrate that patients undergoing a Surgical pro
syrup) form, becoming rapidly available. In this context, the cedure may receive ten (10) or more medicaments during the
active ingredient may adversely react with a co-administered Surgery and the resulting Surgical recovery period. Some
drug, for example a less bioavailable Solid or semi-solid, in a patients who have undergone organ transplantation or who
physiological environment. Thus, the true therapeutic benefit 45 have contracted human immunodeficiency virus (HIV) may
resulting from the pharmacological effects of the individual receive three (3) or more medicaments which require multiple
active agents may never be realized. It would be desirable to administrations per day. HIV patients often receive many
co-administer plural active ingredients while insuring against more than three (3) medicaments. These medicaments may be
the potential of Such harmful drug-drug interactions. necessary for the treatment of several conditions occurring in
Providing active ingredients or medicaments in separate 50 a plurality of organ systems or they may be necessary to treat
capsules may also be undesirable in the context of patient a single condition or some combination thereof.
compliance. Geriatric and pediatric populations in particular In some cases, it may be desirous to combine a plurality of
disfavor the handling and consumption of multiple capsules medicaments because of a synergistic interaction between a
of active ingredients. Patient compliance is essential in main plurality of medicaments. This synergy may enhance the
taining patient health in many dosage regimens. For example, 55 efficacy of one or more of the medicaments. Medicaments
deviations from accurate dosing and consistent consumption may be combined to increase the intensity of response or
of immunosuppressant therapies can result in severe or even efficacy. A plurality of medicaments, in combination, may be
lethal consequences for a patient. Providing combined dos homergic (i.e., ellicit the same quality of effect). In many
ages of active ingredients would result in fewer capsules a cases, a plurality of homergic medicaments may also be
patient or consumer would have to take, and thereby contrib 60 homodynamic (i.e., interact with the same receptor). A plu
ute to an overall increase in compliance. rality of homergic medicaments may be additive, Supra-ad
Therefore, it would be desirable to provide a multi-com ditive and infra-additive. A plurality of combined medica
partment capsular delivery apparatus and methods that pro ments which do not produce the same quality of response may
vide active ingredients or medicaments having diverse physi be called, heterergic. When heterergy is found to be a positive
cal properties (e.g., Solid, liquid, gas or dispersion), which 65 effect (i.e., at least one medicament enhances the response to
may or may not be properly combined or stored together into another medicament), this may be called synergism and is
a unitary structure (i.e., multi-compartment capsule) for Sometimes called synergy.
US 7,670,612 B2
7 8
In further cases, it maybe desirous to combinea plurality of costs and, accordingly, reducing the number of capsules con
medicaments to decrease their individual dosages and possi Sumed by a patient or consumer as nutritional or therapeutic
bility for toxicity. It may also be desirous to combine a plu agents.
rality of medicaments to target the treatment of a disease, Further, it is an object of the present invention to provide
illness or condition from divergent angles. It may be desirous novel integrated capsule delivery apparatus and methods for
to combine a plurality of medicaments to minimize the side delivering one or more active ingredients or medicaments
effects and adverse effects of one or more medicaments. It (e.g., pharmaeceutical, biotechical, nutraceutical, vitamin,
may be still further desirous to combine a plurality of medi dietary Supplement, mineral or combination thereof) in the
caments to alter the pharmacokinetic characteristics of one or form of a single dosage, multi-compartment capsule having
more medicaments. For example, alterations in the absorp 10 one or more active ingredients in a primary capsule, and one
tion, distribution, metabolism or elimination of one or more or more active ingredients introduced into a secondary
medicaments. Smaller capsule having a size sufficient for being selectively
Fixed combinations of a plurality of medicaments have positionable within the primary capsule, wherein the active
been generally disfavored due to any number of perceived ingredient(s) within the primary capsule comprises a physical
disadvantages. These disadvantages may include, for 15 state (e.g., Solid, liquid, gas or dispersion) that is different
example: (1) complicating the interpretation of safety and from the physical state of the active ingredient(s) in the sec
efficacy in therapeutic regimens, (2) there may be inter-pa ondary capsule.
tient differences to fixed combinations, (3) there may be It is an additional object of the present invention to provide
difficulties in dosage titration, and (4) the delivery platforms novel integrated capsule delivery apparatus and methods for
for fixed combinations have generally been found to be delivering one or more active ingredients or medicaments
uneconomical to produce. (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
On the other hand, fixed combinations of a plurality of dietary Supplement, mineral or combination thereof) in the
medicaments may lead to several therapeutic advantages, form of a single dosage, multi-compartment capsule having
including, for example, but not by way of limitation: (1) one or more active ingredients in a primary capsule and the
increasing patient compliance with therapy, (2) increasing 25
same active ingredient(s) introduced into a smaller secondary
efficacy by optimizing timing of medicaments, (3) minimi capsule having a size sufficient for being positionable within
zation of side effects and adverse effects, (4) enhancement of the primary capsule, wherein the active ingredient(s) in the
pharmacokinetic characteristics of one or more medicaments primary capsule comprises a physical state (e.g., Solid, liquid,
in a fixed combination, (5) increased patient quality of life, (6) gas or dispersion) different from the active ingredient(s) in the
optimization of institutional resources by minimizing the 30
secondary capsule.
amount of medicament administrations, and (7) minimizing It is a further object of the present invention to provide
patient length of stay in institutional facilities by optimizing novel integrated capsule delivery apparatus and methods for
therapy.
Prior art therapeutic technologies contain isolated delivering one or more active ingredients or medicaments
examples of pharmaceutical formulations containing fixed 35 (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
combinations of medicaments. However, therapeutic tech dietary Supplement, mineral or combination thereof) in the
nologies of the prior art teach a fixed combination, wherein a form of a single dosage, multi-compartment capsule wherein
plurality of medicaments are placed into a single receiving at least one of the primary and secondary capsules include a
chamber in the delivery formulation (i.e., no separation time-release coating for controlling the release of the active
between the plurality of medicaments). 40 ingredient(s) contained therein.
In view of the state of the technology as it exists today, It is also another object of the present invention to provide
generally, therapeutic apparatus and methods are needed to novel integrated capsule delivery apparatus and methods for
provide a plurality of medicaments for medical and Surgical delivering one or more active ingredients or medicaments
conditions, as well as maintenance of normal health function (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
for delivery to animals and humans using a multi-chambered 45 dietary Supplement, mineral or combination thereof) in the
delivery apparatus. Such apparatus and methods for deliver form of a single dosage, multi-compartment capsule having
ing a plurality of medicaments to animals and humans using one or more active ingredients in the capsular body, wherein
a multi-chambered delivery apparatus are contemplated the capsule includes a longitudinally extending body and at
herein. least one dividing wall formed along a length of the extending
50 body to form a first chamber and an opposing second chamber
BRIEF SUMMARY AND OBJECTS OF THE within the capsular body and introducing at least one active
INVENTION ingredient or medicament having a first physical state into the
first chamber and at least one active ingredient or medicament
In view of the foregoing, it is a primary object of the present having a second physical state into a second chamber,
invention to provide novel integrated capsule delivery appa 55 whereas the physical state (e.g., Solid, liquid, gas or disper
ratus and methods for delivering diverse physical states (e.g., sion) of the ingredient(s) in the first chamber is different from
Solid, liquid, gas or dispersion) of a single active ingredient or the physical state of the ingredient(s) in the second chamber.
medicament, or a plurality of active ingredients or medica It is an additional object of the present invention to provide
ments, in a single dosage form, wherein at least two of the novel integrated capsule delivery apparatus and methods for
active ingredients or medicaments have physical states that 60 delivering one or more active ingredients or medicaments
differ. (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
It is also an object of the present invention to provide novel dietary Supplement, mineral or combination thereof) in the
integrated capsule delivery apparatus and methods which form of a single dosage, multi-compartment capsule having a
facilitate various desirable properties including, for example, longitudinally extending body and one or more dividing walls
controlling time-release of key active ingredients or medica 65 disposed along the length of the longitudinally extending
ments, prolonging shelf-life of the active ingredients or medi body of the capsule, wherein the capsule and one or more of
caments, improving palatability, reducing overall production the dividing walls contained therein may include time-release
US 7,670,612 B2
10
coatings for controlling the release of the active ingredients or may beformed having a base, a corresponding cap and one or
medicaments contained therein, respectively. more receiving chambers. The receiving chambers of the
It is a further object of the present invention to provide primary capsule may be formed having an internal periphery
novel integrated capsule delivery apparatus and methods for Sufficient for receiving the secondary capsule and one or more
delivering one or more active ingredients or medicaments active ingredients or medicaments (e.g., pharmaeceutical,
(e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, biotechnical, nutraceutical, vitamin, dietary Supplement,
dietary Supplement, mineral or combination thereof) in the mineral or combination thereof) having a physical state (i.e.,
form of a single dosage, multi-compartment capsule having a Solid, liquid, gas or dispersion) different from the physical
plurality of active ingredients or medicaments having the state of the active ingredient(s) housed within the receiving
physical form of a solid (e.g., pill, tablet, capsule (both hard 10 chamber of the secondary capsule.
and Soft elastic), powder, granulation, flakes, troches (loz As further contemplated herein, a multi-compartment cap
enges and pastilles), Suppositories and semi-solid ointments, Sule is provided comprising a base, a corresponding cap and
pastes, emulsions and creams), a liquid (e.g., Solution, spirits, one or more dividing walls positionable between the base and
elixir and fluid extracts), a gas or a dispersion (e.g., aerosols the cap. Structurally, the size, shape and positioning of the
(liquid or Solid in gas), Suspensions (Solid in liquid), emulsion 15 dividing walls relative to the base and corresponding cap
(liquid in liquid), foam (gas in liquid), Solid foam (Solid in facilitates the formation of at least two, independent and
gas) or gel (liquid or solid in Solid), wherein the physical form separate receiving chambers. Each of the receiving chambers
of the active ingredients differ between a primary and sec having an internal periphery sufficient for receiving one or
ondary capsule, and between one or more dividing walls more active ingredients or medicaments (e.g., pharmaeceuti
disposed in spaced-apart relationship along the length of a cal, biotechnical, nutraceutical, vitamin, dietary Supplement,
longitudinally extending capsular body. mineral or combination thereof) therein. In preferred design,
It is a still further object of the present invention to provide the physical state (e.g., Solid, liquid, gas or dispersion) of the
novel integrated capsule delivery apparatus and methods for active ingredient(s) in the first receiving chamber is different
delivering one or more active ingredients or medicaments from the physical state of the active ingredient(s) in the sec
(e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, 25 ond receiving chamber. After introducing one or more active
dietary Supplement, mineral or combination thereof) in the ingredients or medicaments into each receiving chamber, the
form of a single dosage, multi-compartment capsule, wherein cap may be selectively positioned in Sealing relationship with
an encapsulation process comprises the steps of: (1) provid the base to form one presently preferred embodiment of the
ing a capsule comprising a first end, a second end, a longitu single, dosage multi-compartment capsule.
dinally extending body having a length disposed between the 30 One presently preferred embodiment of an encapsulation
first and second ends, and a plurality of dividing walls spaced process for forming a multi-compartment capsule may com
apart along the length of the extending body, wherein the prise the steps of: (1) providing a primary capsule having a
dividing walls form a plurality of receiving chambers; (2) base, a corresponding cap and a receiving chamber; (2) pro
introducing at least one active ingredient having a first physi viding a secondary capsule having a base, a corresponding
cal state into a first receiving chamber; (3) introducing at least 35 cap and a receiving chamber; (3) introducing at least one
one active ingredient having a second physical state into a ingredient or medicament (e.g., pharmaeceutical, biotechni
second receiving chamber; (4) introducing at least one active cal, nutraceutical, vitamin, dietary Supplement, mineral or
ingredient having a third physical state into a third receiving combination thereof) having a first physical State (e.g., Solid,
chamber, wherein the physical states of at least two of the liquid, gas or dispersion) into at least a portion of the receiv
active ingredients introduced into the first, second or third 40 ing chamber of the secondary capsule and selectively posi
receiving chambers differ; and (5) sealing the first and second tioning the cap in sealing relationship with the base; (4)
ends of said capsule. introducing at least one ingredient or medicament (e.g., phar
Additionally, it is an object of the present invention to maeceutical, biotechnical, nutraceutical, vitamin, dietary
provide novel integrated capsule delivery apparatus and Supplement, mineral or combination thereof) having a second
methods for delivering a single dosage, multi-compartment 45 physical state (e.g., Solid, liquid, gas or dispersion) into at
capsule comprising a capsular base and cap configuration, least a portion of the receiving chamber of the primary cap
wherein the size and shape of the cap, relative to its sealing sule, wherein the first physical state of the ingredient(s) in the
relationship with the base, generally eliminates or Substan secondary capsule is different from the second physical state
tially reduces any potential dead space Volume within the of the ingredient(s) in the primary capsule; and (5) introduc
internal periphery of the capsule, thereby functionally negat 50 ing the secondary capsule into at least a portion of the receiv
ing the opportunity for reaction between an air bubble and one ing chamber of the primary capsule and selectively position
or more active ingredients introduced into the capsule and, ing the cap in sealing relationship with the base to form a
accordingly, improving stability of the capsular ingredient(s). single dosage multi-compartment capsule.
Consistent with the foregoing objects, and in accordance In alternate presently preferred embodiments of the present
with the invention as embodied and broadly described herein, 55 invention, a tertiary capsule comprising a base, a correspond
one presently preferred embodiment of the novel integrated ing cap and a receiving chamber having an internal periphery
capsule delivery apparatus and methods of the present inven Sufficient for receiving one or more active ingredients or
tion comprises a multi-compartment capsule including a pri medicaments (e.g., pharmaeceutical, biotechnical, nutraceu
mary capsule and a secondary capsule selectively position tical, vitamin, dietary Supplement, mineral or combination
able within an internal periphery of the primary capsule. The 60 thereof) may be selectively introduced within an internal
secondary capsule may include a base, a corresponding cap periphery of at least one receiving chamber of the secondary
and one or more receiving chambers. Each of the receiving capsule. After the introduction of at least one active ingredient
chambers of the secondary capsule may be formed having an into one or more receiving chambers of a tertiary capsule
internal periphery Sufficient for receiving at least one active pursuant to an encapsulation process of the present invention,
ingredient or medicament (e.g., pharmaeceutical, biotechni 65 the cap of the tertiary capsule may be selectively positioned in
cal, nutraceutical, Vitamin, dietary Supplement, mineral or sealing relationship with the base and then introduced into at
combination thereof) therein. Similarly, the primary capsule least a portion of the internal periphery of the secondary
US 7,670,612 B2
11 12
capsule, together with one or more active ingredients therein. multiple organ systems in animals or humans using a plurality
It is contemplated herein that at least two of the active ingre of medicaments delivered by a pharmaceutical formulation
dients introduced within the receiving chambers of the pri comprising a multi-chambered apparatus. Accordingly, the
mary, secondary and tertiary capsules, respectively, comprise present invention provides novel delivery apparatus and
at least two different physical states (e.g., Solid, liquid, gas or 5 administration techniques or methods aimed at affecting mul
dispersion). tiple organ systems in an animal or human using a plurality of
In preferred structural design, the primary capsule may medicaments. A delivery apparatus may be in any multi
comprise a cap having a generally U-shaped configuration chambered apparatus, but preferably in a capsular formula
adapted to provide a sealing relationship when engaging the tion. Thus, a plurality of medicaments may be encapsulated
corresponding base, thereby reducing dead space Volume in 10 and stored separately within a larger capsule until the time of
the internal periphery of the cap and receiving chamber of the ingestion, consumption, or the like. Upon consumption, the
base. A cap having a configuration adapted to generally elimi capsule walls of one or more dividing walls of a capsule may
nate or Substantially reduce potential dead space Volume of dissolve to release their contents. Different methods of encap
the cap and receiving chamber of the base may, accordingly, Sulation may be used to deliver their respective contents,
function to negate the potential for a reaction between an air 15 including but not limited to, dissolution, melting, ablation or
bubble and one or more active ingredient(s) introduced into biodegradation of the encapsulating wall. In certain embodi
the base of the primary capsule. ments and as contemplated herein, the medicaments retained
Alternatively, a multi-compartment capsule of the present in the multicompartment capsule may actually diffuse
invention may include the introduction of a filling material through one or more of the encapsulating walls.
into the cap of the primary capsule, the cap having a general In one embodiment of the present invention there is a
cylindrical configuration adapted to provide a sealing rela multi-compartment capsule, comprising a first receiving
tionship when engaging the corresponding base. An amount chamber comprising at least one ingredient having a first
of filling material may be introduced into at least a portion of physical state, wherein said ingredient is selected from the
the internal periphery of the cap to fill, either partially or group consisting of a nutraceutical, a vitamin, a dietary
completely, the inner Volume of the cap, thereby reducing the 25 Supplement and a mineral; and a second receiving chamber
dead space Volume in the cap and the internal periphery of the comprising at least one ingredient having a second physical
receiving chamber of the base. In this regard, the introduction state, wherein said ingredient is selected from the group con
of a filling material relative to the internal periphery of the cap sisting of a nutraceutical, a vitamin, a dietary Supplement and
may generally eliminate or Substantially reduce the potential a mineral; said first physical state of said ingredient of said
dead space Volume, thus functionally negating the potential 30 first receiving chamber being different from said second
for a reaction between an air bubble and one or more active physical State of said ingredient of said second receiving
ingredient(s) introduced into the base of the primary capsule. chamber.
The primary, secondary or tertiary capsules, in accordance In another embodiment of the present invention, there is a
with the present invention, may be formed having the same or multi-compartment capsule as defined above, further com
different colors. Moreover, the base and corresponding cap of 35 prising a base and a corresponding cap, wherein said cap is
a single capsule may be formed having different colors in an configured to provide a sealing relationship when engaging
effort to enhance the aesthetics of the capsule to the consumer. said base.
In one presently preferred embodiment of a multi-compart In another embodiment of the present invention, there is a
ment capsule of the present invention, the dosage may be multi-compartment capsule as defined above, wherein said
banded, sealed or easily dividable in a contact area of the 40 cap comprises a configuration adapted to reduce dead volume
primary and secondary capsules or the sealing band may be space within said first receiving chamber.
color-coded to assist in branding, if desired. In another embodiment of the present invention, there is a
It is further contemplated herein that a multi-compartment multi-compartment capsule as defined above, further com
capsule of the present invention may comprise component prising a filling material introduced into said cap to reduce
parts of the capsule having various time-release coatings to 45 dead volume space within said first receiving chamber.
facilitate the release and ultimately the absorption of those In another embodiment of the present invention, there is a
active ingredients introduced into the different receiving multi-compartment capsule as defined above, wherein said
chambers of the multi-compartment capsule to release at filling material is selected from the group consisting of gela
different release rates. In particular, a primary capsule may be tin, starch, casein, chitosan, Soya bean protein, safflower pro
formed having a conventional time-release coating that dis 50 tein, alginates, gellan gum, carrageenan, Xanthan gum, phta
Solves and releases the active ingredient(s) contained therein lated gelatin, Succinated gelatin, cellulosephtalate-acetate,
before the timed-release of the active ingredient(s) contained polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin,
within a secondary capsule. Likewise, the dividing walls dis polyvinylacetate-phtalate, polymerisates of acrylic or meth
posed within the internal periphery of the base of a capsule acrylic esters and combinations thereof.
may be formed having conventional time-release coatings 55 In another embodiment of the present invention, there is a
that dissolve and release the active ingredients within each multi-compartment capsule as defined above, wherein said
receiving chamber defined by the dividing walls at different first receiving chamber comprises no dead volume space.
rates, thereby delivering the active ingredients or medica In another embodiment of the present invention, there is a
ments contained within a multi-compartment capsule at dif multi-compartment capsule as defined above, wherein said
ferent rates. Certain active ingredients or medicaments may, 60 physical state of said ingredient in said first receiving cham
therefore, be delivered at a selected interval, while other ber is selected from the group consisting of a solid, a liquid, a
ingredients may be released at a later interval. In this way, the gas and a dispersion.
novel design of the multi-compartment capsules of the In another embodiment of the present invention, there is a
present invention may facilitate precision delivery of active multi-compartment capsule as defined above, wherein said
ingredients to targeted areas of the consumer. 65 physical State of said ingredient in said second receiving
Still further, a primary object of the present invention is to chamber is selected from the group consisting of a solid, a
provide novel delivery apparatus and methods for affecting liquid, a gas and a dispersion.
US 7,670,612 B2
13 14
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule as defined above, wherein said
Solid is selected from the group consisting of a pill, a tablet, a second physical state of said ingredient in said secondary
capsule, a powder, granulation, flakes, atroche, a Suppository, capsule is selected from the group consisting of a Solid, a
an ointment, a paste, an emulsion and a cream. liquid, a gas and a dispersion.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule as defined above, wherein said
liquid is selected from the group consisting of a solution, a primary capsule comprises a time-release coating.
spirit, an elixir, a spray, a syrup and a fluid extract. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is a 10 multi-compartment capsule as defined above, wherein said
multi-compartment capsule as defined above, wherein said secondary capsule comprises a time-release coating.
dispersion is selected from the group consisting of an aerosol, In another embodiment of the present invention, there is a
a suspension, an emulsion, a foam, a solid foam and a gel. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a time-release coating of said secondary capsule is different
multi-compartment capsule as defined above, wherein said 15 from said time-release coating of said primary capsule.
first receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said
multi-compartment capsule as defined above, wherein said third receiving chamber comprises a time-release coating.
second receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said
multi-compartment capsule as defined above, wherein said primary capsule is formed of a material selected from the
time-release coating of said second receiving chamber is dif group consisting of gelatin, starch, casein, chitosan, Soya
ferent from said time-release coating of said primary capsule. bean protein, Safflower protein, alginates, gellan gum, carra
In another embodiment of the present invention, there is a geenan, Xanthan gum, phtalated gelatin, Succinated gelatin,
multi-compartment capsule as defined above, further com 25 cellulosephtalate-acetate, oleoresin, polyvinylacetate,
prising a third receiving chamber comprising at least one hydroxypropyl methyl cellulose, polymerisates of acrylic or
ingredient. methacrylic esters, polyvinylacetate-phtalate and combina
In another embodiment of the present invention, there is a tions thereof.
multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is a
ingredient in said third receiving chamber is selected from the 30
multi-compartment capsule as defined above, wherein said
group consisting of a nutraceutical, a vitamin, a dietary primary capsule further comprises a soft elastic capsule
supplement and a mineral. formed of a material selected from the group consisting of
In another embodiment of the present invention, there is a glycerin and Sorbitol.
multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is an
ingredient in said third receiving chamber comprises a physi 35
encapsulation process as defined above, wherein said soft
cal state selected from the group consisting of a solid, a liquid, elastic capsule includes an antimicrobial selected from the
a gas and a dispersion. group consisting of paraben and Sorbic acid.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule as defined above, wherein said
third receiving chamber comprises a time-release coating. 40
In another embodiment of the present invention, there is a secondary capsule is formed of a material selected from the
multi-compartment capsule, comprising a primary capsule group consisting of gelatin, starch, casein, chitosan, Soya
comprising at least one ingredient having a first physical bean protein, Safflower protein, alginates, gellan gum, carra
state, wherein said ingredient is selected from the group con geenan, Xanthan gum, phtalated gelatin, Succinated gelatin,
sisting of a nutraceutical, a vitamin, a dietary Supplement and 45
cellulosephtalate-acetate, oleoresin, polyvinylacetate,
a mineral; a secondary capsule comprising at least one ingre hydroxypropyl methyl cellulose, polymerisates of acrylic or
dient having a second physical state, wherein said ingredient methacrylic esters, polyvinylacetate-phtalate and combina
tions thereof.
is selected from the group consisting of a nutraceutical, a
Vitamin, a dietary Supplement and a mineral; said first physi In another embodiment of the present invention, there is a
cal state of said ingredient of said primary capsule being 50 multi-compartment capsule as defined above, wherein said
different from said second physical state of said ingredient of ingredient introduced in said primary capsule comprises a
said secondary capsule; and said primary capsule comprising moisture content in the range of about 0% to 6% by weight.
an internal periphery Sufficient for receiving said ingredient In another embodiment of the present invention, there is a
and said secondary capsule therein. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a 55 ingredient introduced in said secondary capsule comprises a
multi-compartment capsule as defined above, wherein said moisture content in the range of about 0% to 6% by weight.
primary capsule further comprises a base and a corresponding In another embodiment of the present invention, there is a
cap, wherein said cap is configured to provide a sealing rela multi-compartment capsule as defined above, wherein said
tionship when engaging said base. primary and secondary capsules contain at least one pharma
In another embodiment of the present invention, there is a 60 ceutically acceptable lubricant in the range of about 0% to
multi-compartment capsule as defined above, wherein said 10% by weight.
primary capsule comprises no dead volume space. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said
multi-compartment capsule as defined above, wherein said lubricant is selected from the group consisting of aluminium
first physical state of said ingredient in said primary capsule 65 Stearate, calciumstearate, magnesiumstearate, tinstearate,
is selected from the group consisting of a solid, a liquid, a gas talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid,
and a dispersion. silicones and mixtures thereof.
US 7,670,612 B2
15 16
In another embodiment of the present invention, there is a ypropyl methyl cellulose, polymerisates of acrylic or meth
multi-compartment capsule as defined above, wherein said acrylic esters, polyvinylacetate-phtalate and combinations
primary and secondary capsules have different colors. thereof.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule as defined above, wherein said
primary capsule is formed having a first color. ingredient introduced in said first receiving chamber com
In another embodiment of the present invention, there is a prises a moisture content in the range of about 0% to 6% by
multi-compartment capsule as defined above, wherein said weight.
secondary capsule is formed having a second color different In another embodiment of the present invention, there is a
from said first color of said primary capsule. 10
multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a ingredient introduced in said second receiving chamber com
multi-compartment capsule as defined above, wherein said prises a moisture content in the range of about 0% to 6% by
capsule further comprises a base and a corresponding cap, weight.
wherein said cap is configured to provide a sealing relation In another embodiment of the present invention, there is a
ship when engaging said base. 15
multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a capsule contains at least one pharmaceutically acceptable
multi-compartment capsule as defined above, wherein said lubricant in the range of about 0% to 10% by weight.
base and said cap are formed having different colors. In another embodiment of the present invention there is, an
In another embodiment of the present invention, there is a encapsulation process for forming a multi-compartment cap
multi-compartment capsule as defined above, wherein said Sule, said process comprising the steps of providing a primary
sealing relationship between said base and corresponding cap capsule having a base and a cap; providing a secondary cap
comprises no dead volume space. Sule having a base and a cap; introducing at least one ingre
In another embodiment of the present invention, there is a dient having a first physical state into said secondary capsule,
multi-compartment capsule as defined above, wherein said 25 wherein said ingredient introduced into said primary capsule
physical state of said ingredient in said first receiving cham is selected from the group consisting of a nutraceutical, a
ber is selected from the group consisting of a solid, a liquid, a Vitamin, a dietary Supplement and a mineral; positioning said
gas and a dispersion. cap of said secondary capsule in sealing relationship with said
In another embodiment of the present invention, there is a base; introducing at least one ingredient having a second
multi-compartment capsule as defined above, wherein said 30 physical state into said primary capsule, wherein said ingre
physical State of said ingredient in said second receiving dient introduced into said primary capsule is selected from
chamber capsule is selected from the group consisting of a the group consisting of a nutraceutical, a Vitamin, a dietary
Solid, a liquid, a gas and a dispersion. Supplement and a mineral; and wherein said first physical
In another embodiment of the present invention, there is a state of said ingredient of said secondary capsule is different
multi-compartment capsule as defined above, wherein said 35 from said second physical state of said ingredient of said
capsule comprises a time-release coating. primary capsule; introducing said secondary capsule into said
In another embodiment of the present invention, there is a base of said primary capsule; and positioning said cap of said
multi-compartment capsule as defined above, wherein said primary capsule in sealing relationship with said base.
dividing wall comprises a time-release coating. In another embodiment of the present invention there is, an
In another embodiment of the present invention, there is a 40 encapsulation process as defined above, further comprising
multi-compartment capsule as defined above, wherein said the step of reducing dead volume space within said primary
time-release coating of said dividing wall is different from capsule.
said time-release coating of said capsule.
In another embodiment of the present invention, there is a In another embodiment of the present invention, an encap
multi-compartment capsule as defined above, wherein said Sulation process as defined above, further comprising the step
third receiving chamber comprises a time-release coating.
45 of introducing a filling material into said cap of said primary
capsule to reduce dead volume space.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is an
multi-compartment capsule as defined above, wherein said encapsulation process as defined above, wherein said filling
capsule is formed of a material selected from the group con material is selected from the group consisting of gelatin,
sisting of gelatin, starch, casein, chitosan, Soya bean protein, 50
safflower protein, alginates, gellan gum, carrageenan, Xan starch, casein, chitosan, Soya bean protein, Safflower protein,
than gum, phtalated gelatin, Succinated gelatin, celluloseph alginates, gellan gum, carrageenan, Xanthan gum, phtalated
talate-acetate, oleoresin, polyvinylacetate, hydroxypropyl gelatin, Succinated gelatin, cellulosephtalate-acetate, polyvi
methyl cellulose, polymerisates of acrylic or methacrylic nylacetate, hydroxypropyl methyl cellulose, oleoresin, poly
esters, polyvinylacetate-phtalate and combinations thereof. 55
vinylacetate-phtalate, polymerisates of acrylic or methacrylic
esters and combinations thereof.
In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, an encap
capsule further comprises a soft elastic capsule formed of a Sulation process as defined above, wherein said cap of said
material selected from the group consisting of glycerin and primary capsule comprises a configuration Sufficient for
sorbitol. 60 reducing dead volume space within the primary capsule.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is an
multi-compartment capsule as defined above, wherein said encapsulation process as defined above, wherein said physi
dividing wall is formed of a material selected from the group cal state of said ingredient in said primary capsule is selected
consisting of gelatin, starch, casein, chitosan, Soya bean pro from the group consisting of a solid, a liquid, a gas and a
tein, safflower protein, alginates, gellan gum, carrageenan, 65 dispersion.
Xanthan gum, phtalated gelatin, Succinated gelatin, cellu In another embodiment of the present invention, there is an
losephtalate-acetate, oleoresin, polyvinylacetate, hydrox encapsulation process as defined above, wherein said physi
US 7,670,612 B2
17 18
cal state of said ingredient in said secondary capsule is In another embodiment of the present invention, there is an
selected from the group consisting of a solid, a liquid, a gas encapsulation process as defined above, wherein said ingre
and a dispersion. dient introduced in said primary capsule comprises a mois
In another embodiment of the present invention, there is an ture content in the range of about 0% to 6% by weight.
encapsulation process as defined above, wherein said ingre- 5 In another embodiment of the present invention, there is a
dient introduced into said primary capsule is the same as said multi-compartment capsule as defined above, wherein said
ingredient introduced into said secondary capsule. ingredient introduced in said secondary capsule comprises a
In another embodiment of the present invention, there is an moisture content in the range of about 0% to 6% by weight.
encapsulation process as defined above, wherein said primary In another embodiment of the present invention, there is an
capsule comprises a time-release coating. 10 encapsulation process as defined above, wherein said primary
In another embodiment of the present invention, there is an and secondary capsules contain at least one pharmaceutically
encapsulation process as defined above, wherein said second acceptable lubricant in the range of about 0% to 10% by
ary capsule comprises a time-release coating. weight.
In another embodiment of the present invention, there is an In another embodiment of the present invention, there is an
encapsulation process as defined above, wherein said time 15 encapsulation process as defined above, wherein said lubri
release coating of said secondary capsule is different from cant is selected from the group consisting of aluminiumstear
said time-release coating of said primary capsule. ate, calciumstearate, magnesiumstearate, tinstearate, talc,
In another embodiment of the present invention, there is an Sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid,
encapsulation process as defined above, further comprising silicones and combinations thereof.
the steps of providing a tertiary capsule having a base and a In another embodiment of the present invention, there is an
cap; introducing at least one ingredient having a third physi encapsulation
cal state into said tertiary capsule; positioning said cap of said and secondaryprocess capsules
as defined above, wherein said primary
are formed having different colors.
secondary capsule in sealing relationship with said base; and In another embodiment of the present invention, there is an
introducing said tertiary capsule into said base of said sec encapsulation process for forming a multi-compartment cap
ondary capsule. 25
Sule, said process comprising the steps of providing a capsule
In another embodiment of the present invention, there is an
encapsulation process as defined above, wherein said ingre comprisingextending
a cap, a base configured having a longitudinally
body including a length and at least one dividing
dient in said tertiary capsule is selected from the group con wall formed along said length of said extending body, said
sisting of a nutraceutical, a vitamin, a dietary Supplement and dividing wall adapted to form a first receiving chamber and a
a mineral. 30
In another embodiment of the present invention, there is an havingsecond receiving chamber, introducing at least one ingredient
encapsulation process as defined above, wherein said ingre ber, wherein a first physical state into said second receiving cham
dient in said tertiary capsule comprises a physical state capsule is selected said ingredient introduced into said primary
selected from the group consisting of a solid, a liquid, a gas tical, a vitamin, a dietary from the group consisting of a nutraceu
and a dispersion. 35 Supplement and a mineral; introduc
ing at least one ingredient
In another embodiment of the present invention, there is an said first receiving chamber, having a second physical state into
encapsulation process as defined above, wherein said tertiary duced wherein said ingredient intro
capsule comprises a time-release coating. into said primary capsule is selected from the group
consisting of a nutraceutical, a vitamin,
In another embodiment of the present invention, there is an and a mineral, and wherein said first physical a dietary Supplement
encapsulation process as defined above, wherein said primary 40 ingredient of said second receiving chamber being state of said
capsule is formed of a material selected from the group con from said second physical state of said ingredient of different said first
sisting of gelatin, starch, casein, chitosan, Soya bean protein, receiving chamber, and positioning said cap in sealing rela
safflower protein, alginates, gellan gum, carrageenan, Xan tionship with said base.
than gum, phtalated gelatin, Succinated gelatin, celluloseph
talate-acetate, polyvinylacetate, hydroxypropyl methylcellu 45 In another embodiment of the present invention, there is an
lose, oleoresin, polymerisates of acrylic or mthacrylic esters, the encapsulation process as defined above, further comprising
polyvinylacetate-phtalate and combinations thereof. step of reducing dead volume space within said primary
In another embodiment of the present invention, there is an capsule.
encapsulation process as defined above, wherein said primary In another embodiment of the present invention, there is an
capsule further comprises a soft elastic capsule formed of a 50 encapsulation process as defined above, further comprising
material selected from the group consisting of glycerin and the step of introducing a filling material into said cap to
sorbitol. reduce said dead volume space.
In another embodiment of the present invention, there is an In another embodiment of the present invention, there is an
encapsulation process as defined above, wherein said second encapsulation process as defined above, wherein said filling
ary capsule is formed of a material selected from the group 55 material is selected from the group consisting of gelatin,
consisting of gelatin, starch, casein, chitosan, Soya bean pro starch, casein, chitosan, Soya bean protein, Safflower protein,
tein, safflower protein, alginates, gellan gum, carrageenan, alginates, gellan gum, carrageenan, Xanthan gum, phtalated
Xanthan gum, phtalated gelatin, Succinated gelatin, cellu gelatin, Succinated gelatin, cellulosephtalate-acetate, polyvi
losephtalate-acetate, polyvinylacetate, hydroxypropyl nylacetate, hydroxypropyl methyl cellulose, oleoresin, poly
methyl cellulose, oleoresin, polymerisates of acrylic or 60 vinylacetate-phtalate, polymerisates of acrylic or methacrylic
mthacrylic esters, polyvinylacetate-phtalate and combina esters and combinations thereof.
tions thereof. In another embodiment of the present invention, there is an
In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said cap
encapsulation process as defined above, wherein said second comprises a configuration Sufficient for reducing dead Vol
ary capsule further comprises a soft elastic capsule formed of 65 ume space within said capsule.
a material selected from the group consisting of glycerin and In another embodiment of the present invention, there is an
sorbitol. encapsulation process as defined above, wherein said physi
US 7,670,612 B2
19 20
cal state of said ingredient in said receiving chamber is In another embodiment of the present invention, there is an
selected from the group consisting of a solid, a liquid, a gas encapsulation process as defined above, wherein said base
and a dispersion. and said cap of said capsule are formed having different
In another embodiment of the present invention, there is an colors.
encapsulation process as defined above, wherein said physi 5 In another embodiment of the present invention, there is an
cal state of said ingredient in said second receiving chamber encapsulation process as defined above, further comprising
is selected from the group consisting of a solid, a liquid, a gas the step of introducing two or more dividing walls adapted to
and a dispersion. form a plurality of receiving chambers into said base of said
In another embodiment of the present invention, there is an capsule.
encapsulation process as defined above, wherein said first 10 In another embodiment of the present invention, there is an
receiving chamber comprises a time-release coating. encapsulation process as defined above, further comprising
In another embodiment of the present invention, there is an the step of introducing a capsule into one of said plurality of
encapsulation process as defined above, wherein said second receiving chambers.
receiving chamber comprises a time-release coating. In another embodiment of the present invention, there is an
In another embodiment of the present invention, there is an 15 encapsulation process as defined above, wherein said capsule
encapsulation process as defined above, wherein said time may comprise a multi-compartment capsule.
release coating of said second receiving chamber is different In another embodiment of the present invention, there is a
from said time-release coating of said first receiving chamber. multi-compartment capsule, comprising a first receiving
In another embodiment of the present invention, there is an chamber comprising at least one ingredient having a first
encapsulation process as defined above, further comprising physical state; and a second receiving chamber comprising at
the steps of positioning a second dividing wall along said least one ingredient having a second physical state, wherein
length of said extending body, said second dividing wall said first physical state of said ingredient of said first receiv
adapted to form a third receiving chamber; and introducing at ing chamber being different from said second physical state
least one ingredient having a third physical state into said of said ingredient of said second receiving chamber.
third receiving chamber. 25
In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is an multi-compartment capsule as defined above, wherein said
encapsulation process as defined above, wherein said ingre first receiving chamber comprises no dead space.
dient in said third receiving chamber is selected from the In another embodiment of the present invention, there is a
group consisting of a nutraceutical, a vitamin, a dietary 30
multi-compartment capsule as defined above, wherein said
Supplement and a mineral. cap is configured to reduce dead volume space within said
In another embodiment of the present invention, there is an first receiving chamber.
encapsulation process as defined above, wherein said ingre In another embodiment of the present invention, there is a
dient in said third receiving chamber comprises a physical multi-compartment capsule as defined above, further com
state selected from the group consisting of a solid, a liquid, a 35
prising a filling material introduced into said cap to reduce
gas and a dispersion. dead volume space within said first receiving chamber.
In another embodiment of the present invention, there is an In another embodiment of the present invention, there is a
encapsulation process as defined above, wherein said disper multi-compartment capsule as defined above, wherein said
sion is selected from the group consisting of an aerosol, a ingredient in said first receiving chamber is selected from the
Suspension, an emulsion, a foam, a solid foam and a gel. 40
group consisting of a pharmaceutical, a biotechnical, a nutra
In another embodiment of the present invention, there is an ceutical, a vitamin, a dietary Supplement and a mineral.
encapsulation process as defined above, wherein said third In another embodiment of the present invention, there is a
receiving chamber comprises a time-release coating. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is an ingredient in said second receiving chamber is selected from
encapsulation process as defined above, wherein said capsule 45 the group consisting of a pharmaceutical, a biotechnical, a
is formed of a material selected from the group consisting of nutraceutical, a vitamin, a dietary Supplement and a mineral.
gelatin, starch, casein, chitosan, Soya bean protein, safflower In another embodiment of the present invention, there is a
protein, alginates, gellan gum, carrageenan, Xanthan gum, multi-compartment capsule as defined above, wherein said
phtalated gelatin, Succinated gelatin, cellulosephtalate-ac ingredient in said first receiving chamber comprises a phar
etate, polyvinylacetate, hydroxypropyl methyl cellulose, 50 maceutical and said ingredient in said second receiving cham
oleoresin, polymerisates of acrylic or mthacrylic esters, poly ber comprises a pharmaceutical.
vinylacetate-phtalate and combinations thereof. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is an multi-compartment capsule as defined above, wherein said
encapsulation process as defined above, wherein said capsule ingredient in said first receiving chamber comprises a phar
further comprises a Soft elastic capsule formed of a material 55 maceutical and said ingredient in said second receiving cham
selected from the group consisting of glycerin and Sorbitol. ber is selected from the group consisting of a biotechnical, a
In another embodiment of the present invention, there is an nutraceutical, a vitamin, a dietary Supplement and a mineral.
encapsulation process as defined above, wherein said primary In another embodiment of the present invention, there is a
and secondary capsules contain at least one pharmaceutically multi-compartment capsule as defined above, wherein said
acceptable lubricant in the range of about 0% to 10% by 60 physical state of said ingredient in said first receiving cham
weight. ber is selected from the group consisting of a solid, a liquid, a
In another embodiment of the present invention, there is an gas and a dispersion.
encapsulation process as defined above, wherein said lubri In another embodiment of the present invention, there is a
cant is selected from the group consisting of aluminiumstear multi-compartment capsule as defined above, wherein said
ate, calciumstearate, magnesiumstearate, tinstearate, talc, 65 physical State of said ingredient in said second receiving
Sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid, chamber is selected from the group consisting of a solid, a
silicones and combinations thereof. liquid, a gas and a dispersion.
US 7,670,612 B2
21 22
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule, comprising a capsule compris
time-release coating of said second receiving chamber is dif ing a longitudinally extending body having a length; at least
ferent from said time-release coating of said primary capsule. one dividing wall formed along said length of said extending
In another embodiment of the present invention, there is a body, said dividing wall forming a first receiving chamber and
multi-compartment capsule, comprising a primary capsule a second receiving chamber, said first receiving chamber
comprising at least one ingredient having a first physical comprising at least one ingredient having a first physical
state; a secondary capsule comprising at least one ingredient state; said second receiving chamber comprising at least one
having a second physical state; said first physical state of said ingredient having a second physical state; and said first physi
ingredient of said primary capsule being different from said 10 cal state of said ingredient of said first receiving chamber
second physical state of said ingredient of said secondary being different from said second physical state of said ingre
capsule; and said primary capsule comprising an internal dient of said second receiving chamber.
periphery sufficient for receiving said ingredient and said In another embodiment of the present invention, there is a
secondary capsule therein. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a 15 capsule further comprises a base and a corresponding cap,
multi-compartment capsule as defined above, wherein said wherein said cap is configured to provide a sealing relation
primary capsule further comprises a base and a corresponding ship when engaging said base.
cap, wherein said cap is configured to provide a sealing rela In another embodiment of the present invention, there is a
tionship when engaging said base. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a base and said cap are formed having different colors.
multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is a
primary capsule comprises no dead volume space. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a sealing relationship between said base and corresponding cap
multi-compartment capsule as defined above, wherein said comprises no dead volume space within said capsule.
ingredient in said primary capsule is selected from the group 25
In another embodiment of the present invention, there is a
consisting of a pharmaceutical, a biotechnical, a nutraceuti multi-compartment capsule as defined above, wherein said
cal, a vitamin, a dietary Supplement and a mineral. ingredient in said first receiving chamber comprises a phar
In another embodiment of the present invention, there is a maceutical and said ingredient in said second receiving cham
multi-compartment capsule as defined above, wherein said ber comprises a pharmaceutical.
ingredient in said secondary capsule is selected from the 30
In another embodiment of the present invention, there is a
group consisting of a pharmaceutical, a biotechnical, a nutra multi-compartment capsule as defined above, wherein said
ceutical, a vitamin, a dietary Supplement and a mineral. ingredient in said first receiving chamber comprises a phar
In another embodiment of the present invention, there is a maceutical and said ingredient in said second receiving cham
multi-compartment capsule as defined above, wherein said 35
ber is selected from the group consisting of a biotechnical, a
ingredient in said first receiving chamber comprises a phar nutraceutical, a vitamin, a dietary Supplement and a mineral.
maceutical and said ingredient in said second receiving cham In another embodiment of the present invention, there is a
ber comprises a pharmaceutical. multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a first physical state of said ingredient in said first receiving
multi-compartment capsule as defined above, wherein said 40
chamber is selected from the group consisting of a solid, a
ingredient introduced in said primary capsule comprises a liquid, a gas and a dispersion.
moisture content in the range of about 0% to 6% by weight. In another embodiment of the present invention, there is a
In another embodiment of the present invention, there is a multi-compartment capsule as defined above, wherein said
multi-compartment capsule as defined above, wherein said second physical state of said ingredient in said second receiv
ingredient introduced in said secondary capsule comprises a 45 ing chamber capsule is selected from the group consisting of
moisture content in the range of about 0% to 6% by weight. a solid, a liquid, a gas and a dispersion.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said multi-compartment capsule as defined above, wherein said
primary and secondary capsules contain at least one pharma capsule comprises a time-release coating.
ceutically acceptable lubricant in the range of about 0% to 50 In another embodiment of the present invention, there is a
10% by weight. multi-compartment capsule as defined in above, wherein said
In another embodiment of the present invention, there is a capsule is formed of a material selected from the group con
multi-compartment capsule as defined above, wherein said sisting of gelatin, starch, casein, chitosan, Soya bean protein,
lubricant is selected from the group consisting of aluminium safflower protein, alginates, gellan gum, carrageenan, Xan
Stearate, calciumstearate, magnesiumstearate, tinstearate, 55 than gum, phtalated gelatin, Succinated gelatin, celluloseph
talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid, talate-acetate, polyvinylacetate, hydroxypropyl methyl cellu
silicones and mixtures thereof. lose, oleoresin, polymerisates of acrylic or methacrylic
In another embodiment of the present invention, there is a esters, polyvinylacetate-phtalate and mixtures thereof.
multi-compartment capsule as defined above, wherein said In another embodiment of the present invention, there is a
primary and secondary capsules have different colors. 60 multi-compartment capsule as defined above, wherein said
In another embodiment of the present invention, there is a capsule further comprises a soft elastic capsule formed of a
multi-compartment capsule as defined above, wherein said material selected from the group consisting of glycerin and
primary capsule is formed having a first color. sorbitol.
In another embodiment of the present invention, there is a In another embodiment of the present invention, there is a
multi-compartment capsule as defined above, wherein said 65 multi-compartment capsule as defined above, wherein said
secondary capsule is formed having a second color different lubricant is selected from the group consisting of aluminium
from said first color of said primary capsule. Stearate, calciumstearate, magnesiumstearate, tinstearate,
US 7,670,612 B2
23 24
talc, sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid, release coating of said secondary capsule is different from
silicones and mixtures thereof. said time-release coating of said primary capsule.
In another embodiment of the present invention, there is an In another embodiment of the present invention, there is an
encapsulation process for forming a multi-compartment cap encapsulation process as defined above, further comprising
Sule, said process comprising the steps of providing a primary the steps of providing a tertiary capsule having a base and a
capsule having a base and a cap; providing a secondary cap cap; introducing at least one ingredient having a third physi
Sule having a base and a cap; introducing at least one ingre cal state into said tertiary capsule; positioning said cap of said
dient having a first physical state into said secondary capsule: secondary capsule in sealing relationship with said base; and
positioning said cap of said secondary capsule in sealing introducing said tertiary capsule into said base of said sec
relationship with said base; introducing at least one ingredi 10 ondary capsule.
ent having a second physical state into said primary capsule, In another embodiment of the present invention, there is an
wherein said first physical state of said ingredient of said encapsulation process as defined above, wherein said ingre
secondary capsule is different from said second physical state dient in said tertiary capsule is selected from the group con
of said ingredient of said primary capsule; introducing said sisting of a pharmaceutical, a biotechnical, a nutraceutical, a
secondary capsule into said base of said primary capsule; and 15 Vitamin, a dietary Supplement and a mineral.
positioning said cap of said primary capsule in sealing rela In another embodiment of the present invention, there is an
tionship with said base. encapsulation process as defined above, wherein said ingre
In another embodiment of the present invention, there is an dient in said tertiary capsule comprises a physical state
encapsulation process as defined above, further comprising selected from the group consisting of a solid, a liquid, a gas
the step of reducing dead volume space within said primary and a dispersion.
capsule. In another embodiment of the present invention, there is an
In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said tertiary
encapsulation process as defined above, further comprising capsule comprises a time-release coating.
the step of introducing a filling material into said cap of said In another embodiment of the present invention, there is an
primary capsule to reduce dead volume space. 25 encapsulation process as defined above, wherein said lubri
In another embodiment of the present invention, there is an cant is selected from the group consisting of aluminiumstear
encapsulation process as defined above, wherein said cap of ate, calciumstearate, magnesiumstearate, tinstearate, talc,
said primary capsule comprises a configuration Sufficient for Sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid,
reducing dead volume space within the primary capsule. silicones and combinations thereof.
In another embodiment of the present invention, there is an 30 In another embodiment of the present invention, there is an
encapsulation process as defined above, wherein said ingre encapsulation process as defined above, wherein said primary
dient introduced into said primary capsule is selected from and secondary capsules are formed having different colors.
the group consisting of a pharmaceutical, a biotechnical, a In another embodiment of the present invention, there is an
nutraceutical, a vitamin, a dietary Supplement and a mineral. encapsulation process for forming a multi-compartment cap
In another embodiment of the present invention, there is an 35 Sule, said process comprising the steps of providing a capsule
encapsulation process as defined above, wherein said physi comprising a cap, a base configured having a longitudinally
cal state of said ingredient in said primary capsule is selected extending body including a length and at least one dividing
from the group consisting of a solid, a liquid, a gas and a wall formed along said length of said extending body, said
dispersion. dividing wall adapted to form a first receiving chamber and a
In another embodiment of the present invention, there is an
40 second receiving chamber, introducing at least one ingredient
encapsulation process as defined above, wherein said ingre having a first physical state into said second receiving cham
dient in said secondary capsule is selected from the group ber; introducing at least one ingredient having a second physi
consisting of a pharmaceutical, a biotechnical, a nutraceuti cal state into said first receiving chamber, wherein said first
cal, a vitamin, a dietary Supplement and a mineral. physical State of said ingredient of said second receiving
45 chamber being different from said second physical state of
In another embodiment of the present invention, there is an said ingredient of said first receiving chamber; and position
encapsulation process as defined above, wherein said physi ing said cap in sealing relationship with said base.
cal state of said ingredient in said secondary capsule is In another embodiment of the present invention, there is an
selected from the group consisting of a solid, a liquid, a gas encapsulation process as defined above, further comprising
and a dispersion. 50 the step of reducing dead volume space within said primary
In another embodiment of the present invention, there is an capsule.
encapsulation process as defined above, wherein said ingre In another embodiment of the present invention, there is an
dient in said primary capsule comprises a pharmaceutical and encapsulation process as defined above, wherein said filling
said ingredient in said secondary capsule is selected from the material is selected from the group consisting of gelatin,
group consisting of a pharmaceutical. 55 starch, casein, chitosan, Soya bean protein, Safflower protein,
In another embodiment of the present invention, there is an alginates, gellan gum, carrageenan, Xanthan gum, phtalated
encapsulation process as defined above, wherein said ingre gelatin, Succinated gelatin, cellulosephtalate-acetate, polyvi
dient in said primary capsule comprises a pharmaceutical and nylacetate, hydroxypropyl methyl cellulose, polyvinylac
said ingredient in said secondary capsule is selected from the etate-phtalate, polymerisates of acrylic or methacrylic esters
group consisting of a biotechnical, a nutraceutical, a vitamin, 60 and combinations thereof.
a dietary Supplement and a mineral. In another embodiment of the present invention, there is an
In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said cap
encapsulation process as defined above, wherein said ingre comprises a configuration Sufficient for reducing dead Vol
dient introduced into said primary capsule is the same as said ume space within said capsule.
ingredient introduced into said secondary capsule. 65 In another embodiment of the present invention, there is an
In another embodiment of the present invention, there is an encapsulation process as defined above, wherein said ingre
encapsulation process as defined above, wherein said time dient in said first receiving chamber is selected from the group
US 7,670,612 B2
25 26
consisting of a pharmaceutical, a biotechnical, a nutraceuti ings depict only typical embodiments of the invention and
cal, a vitamin, a dietary Supplement and a mineral. are, therefore, not to be considered limiting of its scope, the
In another embodiment of the present invention, there is an invention will be described with additional specificity and
encapsulation process as defined above, wherein said physi detail through use of the accompanying drawings in which:
cal state of said ingredient in said receiving chamber is FIG. 1 is a flow diagram illustrating one presently preferred
selected from the group consisting of a solid, a liquid, a gas embodiment of a process of the present invention comprising
and a dispersion. the steps of introducing at least one active ingredient or medi
In another embodiment of the present invention, there is an cament having a solid physical state into a secondary capsule
encapsulation process as defined above, wherein said ingre and introducing the secondary capsule into a primary capsule
dient in said second receiving chamber is selected from the 10 further including at least one active ingredient or medicament
group consisting of a pharmaceutical, a biotechnical, a nutra having a liquid physical state;
ceutical, a vitamin, a dietary Supplement and a mineral. FIG. 2 is a cross-sectional view illustrating another pres
In another embodiment of the present invention, there is an ently preferred embodiment of a multi-compartment capsule
encapsulation process as defined above, wherein said physi of the present invention wherein a primary capsule houses a
cal state of said ingredient in said second receiving chamber 15 secondary capsule and a secondary capsule houses a tertiary
is selected from the group consisting of a solid, a liquid, a gas capsule, wherein each of the capsules include one or more
and a dispersion. active ingredients or medicaments and the active
In another embodiment of the present invention, there is an ingredient(s) introduced into at least two of the capsules
encapsulation process as defined above, wherein said ingre comprise different physical states;
dient in said first receiving chamber comprises a pharmaceu FIG. 3 is a perspective view illustrating yet another pres
tical and said ingredient in said second receiving chamber is ently preferred embodiment of a multi-compartment capsule
selected from the group consisting of a pharmaceutical. comprising a base, a cap and a dividing wall positioned
In another embodiment of the present invention, there is an between the base and the cap, wherein the dividing wall
encapsulation process as defined above, wherein said time facilitates the formation of at least two, independent receiving
release coating of said second receiving chamber is different 25 chambers for receiving one or more active ingredients or
from said time-release coating of said first receiving chamber. medicaments having different physical states;
In another embodiment of the present invention, there is an FIG. 4 is a cross-sectional view of the multi-compartment
encapsulation process as defined above, further comprising capsule shown in FIG. 3 wherein the base, the dividing wall
the steps of positioning a second dividing wall along said defining the two receiving chambers and the cap are
length of said extending body of said base, said second divid 30 assembled to form a capsule of the present invention and
ing wall adapted to form a third receiving chamber, and wherein one or more active ingredients or medicaments hav
introducing at least one ingredient having a physical state into ing different physical states are introduced into the receiving
said third receiving chamber. chambers;
In another embodiment of the present invention, there is an FIG. 5 is a perspective view illustrating an alternate pres
encapsulation process as defined above, wherein said ingre 35 ently preferred embodiment of a multi-compartment capsule
dient introduced into said third receiving chamber is selected of the present invention having a primary capsule comprising
from the group consisting of a pharmaceutical, a biotechnical, a capsular base configured with a longitudinally extending
a nutraceutical, a vitamin, a dietary Supplement and a mineral. body, a corresponding cap and a series of dividing walls
In another embodiment of the present invention, there is an disposed in spaced apart relationship along the length of the
encapsulation process as defined above, wherein said physi 40 longitudinally extending body of the base, wherein the divid
cal state of said ingredient introduced into said third receiving ing walls define a plurality of independent receiving cham
chamber is selected from the group consisting of a Solid, a bers having an internal periphery Sufficient for introducing
liquid, a gas and a dispersion. one or more active ingredients or medicaments having differ
In another embodiment of the present invention, there is an ent physical States therein and for introducing a secondary
encapsulation process as defined above, wherein said second 45 capsule, having one or more active ingredients contained
dividing wall comprises a time-release coating. therein, within at least one of said receiving chambers;
In another embodiment of the present invention, there is an FIG. 6 is a cross-sectional view of the multi-compartment
encapsulation process as defined above, wherein said capsule capsule shown in FIG. 5 wherein the base and the cap are
further comprises a Soft elastic capsule formed of a material assembled to form a single dosage capsule having a series of
selected from the group consisting of glycerin and Sorbitol. 50 dividing walls that define a plurality of chambers for receiv
In another embodiment of the present invention, there is an ing one or more active ingredients or medicaments, wherein
encapsulation process as defined above, wherein said lubri the active ingredient(s) in at least two of the receiving cham
cant is selected from the group consisting of aluminiumstear bers comprise different physical states;
ate, calciumstearate, magnesiumstearate, tinstearate, talc, FIG. 7 is a perspective view illustrating yet another pres
Sodium lauryl Sulfate, lecithins, mineral oils, Stearic acid, 55 ently preferred embodiment of a multi-compartment capsule
silicones and combinations thereof. of the present invention having a primary capsule comprising
In another embodiment of the present invention, there is an a capsular base configured with a longitudinally extending
encapsulation process as defined above, wherein said base body, a corresponding cap and a series of dividing walls
and said cap of said capsule are formed having different disposed in spaced apart relationship, both vertically and
colors. 60 horizontally, along the length of the longitudinally extending
body of the base, wherein the dividing walls define a plurality
BRIEF DESCRIPTION OF THE DRAWINGS of independent receiving chambers having an internal periph
ery Sufficient for introducing one or more active ingredients
The foregoing and other objects and features of the present or medicaments having different physical states therein;
invention will become more fully apparent from the following 65 FIG. 8 is a perspective view illustrating an alternate pre
description and appended claims, taken in conjunction with ferred embodiment of the multi-compartment capsule shown
the accompanying drawings. Understanding that these draw in FIG. 7, wherein the multi-compartment capsule includes a
US 7,670,612 B2
27 28
primary capsule comprising a capsular base configured with capsule comprises a physical state (e.g., Solid, liquid, gas or
a longitudinally extending body, a corresponding cap and a dispersion) which differs from the physical state of the active
series of dividing walls disposed in spaced apart relationship, ingredient(s) introduced into the receiving chambers of the
both vertically and horizontally, along the length of the lon secondary and tertiary capsules, the primary capsule further
gitudinally extending body of the base, wherein the dividing comprising a filling material introduced into the internal
walls define a plurality of independent receiving chambers periphery of the cap having a general conical configuration
having an internal periphery Sufficient for introducing one or and adapted to provide a sealing relationship when engaging
more active ingredients or medicaments having different the corresponding base, thereby reducing dead space Volume
physical states therein and for introducing a secondary cap in the internal periphery of the receiving chamber of the base
Sule, having one or more active ingredients contained therein, 10 of the primary capsule.
within at least one of said receiving chambers;
FIG. 9 is a perspective view illustrating yet another pres DETAILED DESCRIPTION OF THE PREFERRED
ently preferred embodiment of a multi-compartment capsule EMBODIMENTS
of the present invention wherein the multi-compartment cap
sule shown in FIG. 7 is introduced within the internal periph 15 It will be readily understood that the components of the
ery of a receiving chamber of a primary capsule having one or present invention, as generally described and illustrated in the
more active ingredients also contained therein; Figures herein, could be arranged and designed in a wide
FIG. 10 is a cross-sectional view illustrating a presently variety of different configurations and process steps. Those of
preferred embodiment of a multi-compartment capsule of the ordinary skill in the art will, of course, appreciate that various
present invention including a secondary capsule having one modifications to the details herein may easily be made with
or more active ingredients or medicaments selectively intro out departing from the essential characteristics of the inven
duced into the internal periphery of a primary capsule having tion, as described. Thus, the following more detailed descrip
one or more active ingredients or medicaments, wherein the tion of the embodiments of apparatus and methods of the
active ingredient(s) introduced into the primary capsule com present invention, as represented in FIGS. 1 through 13, is not
prises a physical state (e.g., Solid, liquid, gas or dispersion) 25 intended to limit the scope of the invention, as claimed, but it
which differs from the physical state of the active is merely representative of the presently preferred embodi
ingredient(s) introduced into the internal periphery of the ments of the invention.
secondary capsule, the primary capsule further comprising a The presently preferred embodiments of the invention will
cap having a generally U-shaped configuration adapted to be best understood by reference to the drawings, wherein like
provide a sealing relationship when engaging the correspond 30 parts are designated by like numerals throughout.
ing base, thereby reducing dead space Volume in the internal One presently preferred embodiment of the present inven
periphery of the receiving chamber of the base; tion, designated generally at 10, is best illustrated in FIG. 1.
FIG. 11 is a perspective view illustrating yet another pres As shown, a multi-compartment capsule 10 is illustrated
ently preferred embodiment of a multi-compartment capsule comprising a primary capsule 11 and a secondary capsule 20
of the present invention including a secondary capsule having 35 selectively introduced within at least a portion of an internal
one or more active ingredients or medicaments and having a periphery of the primary capsule. The secondary capsule 20
size and shape sufficient for being selectively introduced into includes a base 24, a corresponding cap 22 and a receiving
the internal periphery of a primary capsule having one or chamber 28 formed between the base and cap. The receiving
more active ingredients or medicaments, wherein the active chamber 28 is configured having an internal periphery suffi
ingredient(s) introduced into the primary capsule comprises a 40 cient for receiving at least one active ingredient or medica
physical state (e.g., Solid, liquid, gas or dispersion) which ment (e.g., pharmaeceutical, biotechnical, nutraceutical, Vita
differs from the physical state of the active ingredient(s) min, dietary Supplement, mineral or combination thereof)
introduced into the internal periphery of the secondary cap therein. In similar structural design, the primary capsule 11
Sule, the primary capsule further comprising a filling material may be formed having a base 14, a corresponding cap 12 and
introduced into the internal periphery of the cap having a 45 a receiving chamber 18 formed between the base and cap. The
general conical configuration and adapted to provide a seal receiving chamber 18 of the primary capsule 11 is preferably
ing relationship when engaging the corresponding base, formed having an internal periphery sufficient for receiving
thereby reducing dead space Volume in the internal periphery the secondary capsule 20, together with at least one active
of the receiving chamber of the base; ingredient or medicament (e.g., pharmaeceutical, biotechni
FIG. 12 is a cross-sectional view of the multi-compartment 50 cal, nutraceutical, vitamin, dietary Supplement, mineral or
capsule shown in FIG. 11 wherein a sufficient amount of combination thereof) therein.
filling material is introduced into the internal periphery of the Still referring to FIG. 1, one presently preferred embodi
cap, thereby functioning to eliminate or significantly reduce ment of an encapsulation process for forming a multi-com
the dead space Volume in the receiving chamber of the pri partment capsule 10 is comprising the steps of: (1) providing
mary capsule; and 55 a primary capsule 11 having a base 14, a corresponding cap 12
FIG. 13 is a cross-sectional view illustrating an alternate and a receiving chamber 18; (2) providing a secondary cap
presently preferred embodiment of a multi-compartment cap Sule 20 having a base 24, a corresponding cap 22 and a
Sule of the present invention comprising a tertiary capsule receiving chamber 28; (3) introducing at least one ingredient
having one or more active ingredients or medicaments and or medicament (e.g., pharmaeceutical, biotechnical, nutra
having a size a shape sufficient for being introduced into at 60 ceutical, Vitamin, dietary Supplement, mineral or combina
least a portion of the internal periphery of the receiving cham tion thereof) having a first physical state (e.g., Solid, liquid,
ber of a secondary capsule having one or more active ingre gas or dispersion) into at least a portion of the receiving
dients or medicaments also introduced therein, the size and chamber 28 of the secondary capsule 20 and selectively posi
shape of the secondary capsule Sufficient for being selectively tioning the cap 22 in sealing relationship with the base 24; (4)
introduced into the internal periphery of a primary capsule 65 introducing at least one ingredient or medicament (e.g., phar
having one or more active ingredients or medicaments, maeceutical, biotechnical, nutraceutical, vitamin, dietary
wherein the active ingredient(s) introduced into the primary Supplement, mineral or combination thereof) having a second
US 7,670,612 B2
29 30
physical state (e.g., Solid, liquid, gas or dispersion) into at sponding cap 112 and a receiving chamber 118 defined
least a portion of the receiving chamber 18 of the primary between the base and cap; (2) providing a secondary capsule
capsule 11, wherein the first physical state of the ingredient(s) 120 having a base 124, a corresponding cap 122 and a receiv
in the secondary capsule is different from the second physical ing chamber 128 defined between the base and cap; (3) pro
state of the ingredient(s) in the primary capsule; and (5) viding a tertiary capsule 130 having a base 134, a correspond
introducing the secondary capsule 20 into at least a portion of ing cap 132 and a receiving chamber 138 defined between the
the receiving chamber 18 of the primary capsule 11 and base and cap; (4) introducing at least one ingredient (e.g.,
selectively positioning the cap 12 in Sealing relationship with pharmaeceutical, biotechnical, nutraceutical, Vitamin,
the base 14 to form a single dosage multi-compartment cap dietary Supplement, mineral or combination thereof) having a
Sule. 10 first physical state (e.g., Solid, liquid, gas or dispersion) into at
As shown, a solid is selectively introduced within at least a least a portion of the receiving chamber 138 of the tertiary
portion of the internal periphery of the receiving chamber 28 capsule 130 and selectively positioning the cap 132 in sealing
of the secondary capsule 20 and a liquid is selectively intro relationship with the base 134; (5) introducing at least one
duced within at least a portion of the internal periphery of the ingredient (e.g., pharmaeceutical, biotechnical, nutraceuti
receiving chamber 18 of the primary capsule 11. Although the 15 cal, Vitamin, dietary Supplement, mineral or combination
ingredient(s) introduced into the receiving chamber 18 of the thereof) having a second physical state (e.g., Solid, liquid, gas
primary capsule 11 may be the same or different from the or dispersion) into at least a portion of the receiving chamber
ingredient(s) introduced into the receiving chamber 28 of the 128 of the secondary capsule 120, wherein the first physical
secondary capsule, the active ingredient(s) in the primary state of the ingredient(s) in the tertiary capsule 130 are the
capsule 11 have a physical state (i.e., Solid, liquid, gas or same as the second physical state of the ingredient(s) in the
dispersion) that varies from the physical state of the active secondary capsule 120; (6) introducing the tertiary capsule
ingredient(s) in the secondary capsule 20. Accordingly, those 130 into at least a portion of the receiving chamber 218 of the
skilled in the art will readily recognize other possible modi secondary capsule 120 and selectively positioning the cap
fications and adaptations relative to the contemplated varia 122 in sealing relationship with the base 124; (7) introducing
tions in physical states of the active ingredient(s) selectively 25 at least one ingredient (e.g., pharmaeceutical, biotechnical,
positionable within the receiving chambers 18, 28 of the nutraceutical, vitamin, dietary Supplement, mineral or com
primary and secondary capsules, respectively, which are con bination thereof) having a third physical state (e.g., Solid,
sistent with the spirit and scope of the present invention. It is liquid, gas or dispersion) into at least a portion of the receiv
intended, therefore, that the figures and examples provided ing chamber 118 of the primary capsule 111, wherein the
herein be viewed as exemplary of the principles of the present 30 third physical State of the ingredient(s) in the primary capsule
invention, and not as restrictive to a particular structure or are different from the first and second physical states of the
method for implementing those principles. ingredient(s) in the tertiary capsule 130 and the secondary
Referring now to FIG. 2, an alternate presently preferred capsule 120, respectively; and (8) introducing the secondary
embodiment of a multi-compartment capsule 110 is shown capsule 120 into at least a portion of the receiving chamber
comprising a primary capsule 111, a secondary capsule 120 35 118 of the primary capsule 111 and selectively positioning the
and a tertiary capsule 130. The tertiary capsule 130 includes cap 112 in sealing relationship with the base 114 to form a
a base 134, a corresponding cap 132 and a receiving chamber single dosage multi-compartment capsule.
138 formed between the base and cap. The receiving chamber In the presently preferred embodiment illustrated in FIG.2,
138 is preferably formed having an internal periphery suffi a liquid may be selectively introduced into at least a portion of
cient for receiving at least one active ingredient or medica 40 the internal periphery of the receiving chamber 118 of the
ment (e.g., pharmaeceutical, biotechnical, nutraceutical, Vita primary capsule 111, a solid may be selectively introduced
min, dietary Supplement, mineral or combination thereof). into at least a portion of the internal periphery of the receiving
Structurally, the tertiary capsule 130 is configured having a chamber 128 of the secondary capsule 120 and a solid may be
size sufficient for being selectively introduced within at least selectively introduced into at least a portion of the receiving
a portion of an internal periphery of a receiving chamber 128 45 chamber 138 of the tertiary capsule 130. Although the ingre
defined between a base 124 and a corresponding cap 122 of dient(s) selectively introduced into the receiving chambers
the secondary capsule 120. One or more active ingredients or 118, 128, 138 of the primary, secondary and tertiary capsules
medicaments (e.g., pharmaeceutical, biotechnical, nutraceu 111, 120, 130, respectively, may be the same or different, the
tical, vitamin, dietary Supplement, mineral or combination active ingredient(s) in at least two of the receiving chambers
thereof) may be introduced into at least a portion of the 50 comprise at least two different physical States (e.g., Solid,
receiving chamber 128 of the secondary capsule 120, together liquid, gas or dispersion). It is further contemplated herein as
with the introduction of the tertiary capsule 130 comprising an alternate embodiment that the active ingredient(s) intro
its active ingredient(s). The secondary capsule 120 having its duced in the receiving chamber 118 of the primary capsule
active ingredient(s) and housing the tertiary capsule 130 with 111 comprises a physical State (e.g., Solid, liquid, gas or
its active ingredient(s) may then be selectively introduced 55 dispersion) different from the physical state of the active
within at least a portion of an internal periphery of a receiving ingredient(s) contained within the receiving chamber 128 of
chamber 118 of the primary capsule 111 defined between a the secondary capsule 120 which is different from the physi
base 114 and a corresponding cap 112. Preferably, the receiv cal State of the active ingredient(s) contained within the
ing chamber 118 of the primary capsule 111 may also include receiving chamber 138 of the tertiary capsule 130. Those
one or more active ingredients or medicaments (e.g., phar 60 skilled in the art will readily recognize other possible modi
maeceutical, biotechnical, nutraceutical, Vitamin, dietary fications and adaptations relative to contemplated variations
Supplement, mineral or combination thereof) introduced in physical states of the active ingredient(s) selectively intro
therein. duced within the receiving chambers 118, 128, 138 of the
Still referring to FIG. 2, another presently preferred primary, secondary and tertiary capsules, respectively, which
embodiment of an encapsulation process for forming a multi 65 are consistent with the spirit and scope of the present inven
compartment capsule 110 may comprise the steps of: (1) tion. It is intended, therefore, that the figures and examples
providing a primary capsule 111 having a base 114, a corre provided herein be viewed as exemplary of the principles of
US 7,670,612 B2
31 32
the present invention, and not as restrictive to a particular As best shown in FIG. 6, the dividing walls 316a, 316b,
structure or method for implementing those principles. 3.16c are preferably seated within the internal periphery of the
Referring now to FIGS. 3 and 4, another presently pre base 314 of the primary capsule 311 and in a spaced apart
ferred embodiment of a multi-compartment capsule 210 is relationship along the length of the longitudinally extending
shown comprising a base 214, a corresponding cap 212 and a body and form four independent receiving chambers 318a,
dividing wall 216 positionable between the base and the cap. 318b, 318c, 318d. In one presently preferred embodiment of
Structurally, the size, shape and positioning of the dividing the multi-compartment capsule 310 of the present invention,
wall 216 relative to the base 214 and corresponding cap 212 each of the receiving chambers 318a,318b,318c comprises at
facilitates the formation of at least two, independent and least one active ingredient or medicament having a physical
separate receiving chambers 218a, 218b, each having an 10
state (e.g., Solid, liquid, gas or dispersion) different from the
internal periphery sufficient for receiving one or more active physical state of the ingredient(s) in the other receiving cham
ingredients or medicaments (e.g., pharmaeceutical, biotech bers.
nical, nutraceutical, vitamin, dietary Supplement, mineral or As illustrated by way of example, and not by way of restric
combination thereof) therein. As best shown in FIG. 4, the tion, a Solid may be selectively introduced into at least a
dividing wall 216 seats within the internal periphery of both 15
portion of the internal periphery of the receiving chamber
the base 214 and the corresponding cap 212. After introduc 3.18a, a dispersion may be selectively introduced into at least
ing one or more active ingredients or medicaments into a portion of the internal periphery of the receiving chamber
receiving chamber 218b and disposing the dividing wall 216
relative thereto, one or more active ingredients or medica 318b, a liquid may be selectively introduced into at least a
ments (e.g., pharmaeceutical, biotechnical, nutraceutical, portion of the internal periphery of the receiving chamber
Vitamin, dietary Supplement, mineral or combination thereof) 318c and a secondary capsule 320 may be selectively intro
may be introduced into receiving chamber 218a and the cap duced into at least a portion of the internal periphery of the
may be selectively positioned in Sealing relationship with the receiving chamber 318d. As contemplated herein, receiving
base 214 to form one presently preferred embodiment of the chamber 318d may be further configured having an internal
single, dosage multi-compartment capsule 210. Moreover, 25 periphery sufficient for receiving a secondary capsule 320,
the dividing wall 216 may functionally assist in forming a together with at least one active ingredient or medicament
therein.
sealing relationship between the base 214 and corresponding
cap 212 of the multi-compartment capsule 210, if desired. One presently preferred embodiment of an encapsulation
In one presently preferred embodiment of the multi-com process, as defined by the structural configuration of the
partment capsule 211 of the present invention, a Solid may be 30 multi-compartment capsule 310 illustrated in FIGS. 5 and 6.
selectively introduced into at least a portion of the internal may comprise the steps of: (1) introducing a secondary cap
periphery of the receiving chamber 218a and a liquid may be Sule 320 (e.g., tablet) and one or more active ingredients or
selectively introduced into at least a portion of the internal medicaments into receiving chamber 318d, (2) selectively
periphery of the receiving chamber 218b. Although the ingre positioning dividing wall 316c along the length of the elon
dient(s) introduced into the receiving chamber 218a may be 35 gated body of the base 314; (3) introducing one or more active
the same or different from the ingredient(s) introduced into ingredients or medicaments (e.g., pharmaeceutical, biotech
the receiving chamber 218, the active ingredient(s) in the first nical, nutraceutical, vitamin, dietary Supplement, mineral or
receiving chamber 218a preferably comprise a physical State combination thereof) into receiving chamber 318c.; (4) selec
(e.g., Solid, liquid, gas or dispersion) that is different from the tively positioning dividing wall 316b along the length of the
physical state of the active ingredient(s) in the second receiv 40 elongated body of the base 314 in a spaced apart relationship
ing chamber 218b. Those skilled in the art will readily rec to dividing wall 316c; (5) introducing one or more active
ognize other possible modifications and adaptations relative ingredients or medicaments (e.g., pharmaeceutical, biotech
to the contemplated variations in physical states (e.g., Solid, nical, nutraceutical, vitamin, dietary Supplement, mineral or
liquid, gas and dispersion) of the active ingredient(s) selec combination thereof) into receiving chamber 318b; (6) selec
tively positionable within the receiving chambers 218a, 218b 45 tively positioning dividing wall 316a along the length of the
which are consistent with the spirit and scope of the present elongated body of the base 314 in a spaced apart relationship
invention. It is intended, therefore, that the figures and to dividing wall 316b; and (7) selectively positioning the cap
examples provided herein be viewed as exemplary of the 312 in sealing relationship with the base 314 to form a pres
principles of the present invention, and not as restrictive to a ently preferred embodiment of a single, dosage multi-com
particular structure or method for implementing those prin 50 partment capsule 310. The dividing wall 316a may also func
ciples. tion in the formation of the sealing relationship between the
Referring now to FIGS. 5 and 6, another presently pre base 314 and the corresponding cap 312, if desired.
ferred embodiment of a multi-compartment capsule, desig Although the ingredient(s) introduced into one of the
nated as 310, is shown including a primary capsule 311 com receiving chambers 318 may be the same ingredient or may
prising a capsular base 314 configured having an elongated or 55 be different from the ingredient(s) introduced into the other
longitudinally extending body, a corresponding cap 312 and a receiving chambers, the active ingredient(s) in at least two of
plurality of dividing walls 316 selectively disposed along the the receiving chambers 318 preferably comprise a physical
length of the longitudinally extending body of the base. Pref state (e.g., Solid, liquid, gas or dispersion) that is different
erably, the structural size, shape and positioning of the divid from the physical state of the active ingredient(s) in one or
ing walls 316a, 316b, 316c along the length of the elongated 60 more of the remaining receiving chambers. Those skilled in
body of the base 314 facilitate the formation of a plurality of the art will readily recognize other possible modifications and
independent receiving chambers 318a, 318b, 318c, 318d. adaptations relative to the contemplated variations in physical
Each receiving chamber 318a, 318b, 318c, 318d of the pri states (e.g., Solid, liquid, gas and dispersion) of the active
mary capsule 311 having an internal periphery Sufficient for ingredient(s) selectively introduced within the receiving
receiving one or more active ingredients or medicaments 65 chambers 318 which are consistent with the spirit and scope
(e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, of the present invention. It is intended, therefore, that the
dietary Supplement, mineral or combination thereof) therein. figures and examples provided herein be viewed as exemplary
US 7,670,612 B2
33 34
of the principles of the present invention, and not as restrictive Although the ingredient(s) introduced into one of the
to a particular structure or method for implementing those receiving chambers 418 may be the same ingredient or may
principles. be different from the ingredient(s) introduced into the other
Another presently preferred embodiment of a multi-com receiving chambers, the active ingredient(s) in at least two of
partment capsule of the present invention, generally desig the receiving chambers 418 preferably comprise a physical
nated as 410 in FIG. 7, is shown comprising a capsular base state (e.g., Solid, liquid, gas or dispersion) that is different
414 preferably configured having an elongated or longitudi from the physical state of the active ingredient(s) in one or
nally extending body, a corresponding cap 412 and a plurality more of the remaining receiving chambers. Those skilled in
of dividing walls 416 selectively disposed along the length of the art will readily recognize other possible modifications and
the longitudinally extending body of the base, both horizon 10 adaptations relative to the contemplated variations in physical
tally and vertically. In structural design, the size, shape and states (e.g., Solid, liquid, gas and dispersion) of the active
positioning of the dividing walls 416a, 416b, 416C, 416d. ingredient(s) selectively introduced within the receiving
416e along the length of the longitudinally extending body of chambers 418 which are consistent with the spirit and scope
the base 414 facilitate the formation of a plurality of indepen of the present invention. It is intended, therefore, that the
dent receiving chambers 418. 15 figures and examples provided herein be viewed as exemplary
In one presently preferred embodiment, the dividing walls of the principles of the present invention, and not as restrictive
416a, 416b, 416c, 416d, 416e are preferably disposed or to a particular structure or method for implementing those
seated in a spaced apart relationship within the internal principles.
periphery of the base 414 of the primary capsule 411 along the Referring now to FIG. 8, an alternate presently preferred
length of the longitudinally extending body, whereby forming embodiment of a multi-compartment capsule 510 includes a
five (5) independent receiving chambers 418a, 418b, 418c, capsular base 514 preferably configured having an elongated
418d, 418e. Each receiving chamber 4.18a, 418b, 418c, 418d. or longitudinally extending body, a corresponding cap 512
418e of the primary capsule 411 are preferably configured and a plurality of dividing walls 516 selectively disposed
having an internal periphery dimensionally sufficient for along the length of the longitudinally extending body of the
receiving one or more active ingredients or medicaments 25 base, both horizontally and vertically. Instructural design, the
(e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin, size, shape and positioning of the dividing walls 516a, 516b,
dietary Supplement, mineral or combination thereof) therein. 516c. 516d along the length of the longitudinally extending
Still referring to FIG. 7, one presently preferred embodi body of the base 514 facilitate the formation of a plurality of
ment of an encapsulation process, as defined by the structural independent receiving chambers 518.
configuration of the multi-compartment capsule 410, may 30 In one presently preferred embodiment, the dividing walls
comprise the steps of: (1) introducing one or more active 516a, 516b, 516c, 516d, 516e are preferably disposed or
ingredients or medicaments into receiving chamber 418e seated in a spaced apart relationship within the internal
defined by dividing walls 416d, 416e which are vertically periphery of the base 514 of the primary capsule 511 along the
disposed along the length of the elongated body of the base length of the longitudinally extending body, whereby forming
414; (2) introducing one or more active ingredients or medi 35 five (5) independent receiving chambers 518a, 518b, 518c,
caments into receiving chamber 418d defined by dividing 518d,518e. Each of the receiving chamber 518a, 518b,518c,
walls 416c, 416d which are vertically disposed along the 518d, 518e of the primary capsule 411 are preferably config
length of the elongated body of the base 414; (3) introducing ured having an internal periphery dimensionally sufficient for
one or more active ingredients or medicaments into receiving receiving one or more active ingredients or medicaments
chamber 418c defined by dividing walls 416b, 416c which are 40 (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
Vertically disposed along the length of the elongated body of dietary Supplement, mineral or combination thereof) therein.
the base 414; (4) introducing one or more active ingredients Moreover, receiving chamber 518d is formed having an inter
or medicaments into receiving chamber 418b defined by nal periphery sufficient for receiving a secondary capsule
dividing walls 416b, 416e which are vertically disposed along 520. The secondary capsule 520 being configured with a base
the length of the elongated body of the base 414; (5) disposing 45 524, corresponding cap 522 and a dividing wall 526 defining
dividing wall 416a along the length of the elongated body of a first receiving chamber 528a and a second receiving cham
the base 414 perpendicular to the disposition of dividing walls ber 528b. The first receiving chamber 528a is preferably
416b, 416c, 416d, 416e and introducing one or more active configured having an internal periphery Sufficient for receiv
ingredients or medicaments into receiving chamber 418a; ing one or more active ingredients or medicaments (e.g.,
and (6) Selectively positioning the cap 412 in sealing relation 50 pharmaeceutical, biotechnical, nutraceutical, Vitamin,
ship with the base 414 to form one presently preferred dietary Supplement, mineral or combination thereof) having a
embodiment of a single, dosage multi-compartment capsule first physical state (e.g., Solid, liquid, gas or dispersion)
410. As appreciated, the dividing wall 416a may also function therein. Similarly, the second receiving chamber 528b is con
in the formation of the sealing relationship between the base figured having an internal periphery Sufficient for receiving
414 and the corresponding cap 412, if structurally desired. 55 one or more active ingredients or medicaments (e.g., phar
As illustrated by way of example, and not by way of restric maeceutical, biotechnical, nutraceutical, vitamin, dietary
tion, a Solid may be selectively introduced into at least a Supplement, mineral or combination thereof) having a second
portion of the internal periphery of the receiving chamber physical state (e.g., Solid, liquid, gas or dispersion), wherein
4.18a, a dispersion may be selectively introduced into at least the physical state of the ingredient(s) in the second receiving
a portion of the internal periphery of the receiving chamber 60 chamber varies from the physical state of the ingredient(s) in
418b, a liquid may be selectively introduced into at least a the first receiving chamber. As contemplated and disclosed
portion of the internal periphery of the receiving chamber hereinabove, after the ingredients are introduced into the
418c, a solid may be selectively introduced into at least a respective receiving chambers 528a, 528b, the cap 522 may
portion of the internal periphery of the receiving chamber be positioned in sealing relationship with the base 524 of the
418d and a liquid may be selectively introduced into at least 65 secondary capsule 520.
a portion of the internal periphery of the receiving chamber Still referring to FIG. 8, as illustrated by way of example,
418e. and not by way of restriction, a solid may be selectively
US 7,670,612 B2
35 36
introduced into at least a portion of the internal periphery of different from the ingredient(s) introduced into the other
the receiving chamber 528a and a liquid may be selectively receiving chambers, the active ingredient(s) in at least two of
introduced into at least a portion of the internal periphery of the receiving chambers 518 preferably comprise a physical
the receiving chamber 528b. Although the ingredient(s) intro state (e.g., Solid, liquid, gas or dispersion) that is different
duced into one of the receiving chamber 528a may be the from the physical state of the active ingredient(s) in one or
same ingredient or may be different from the ingredient(s) more of the remaining receiving chambers. Those skilled in
introduced into receiving chamber 528b, the active the art will readily recognize other possible modifications and
ingredient(s) in the first receiving chamber 528a comprise a adaptations relative to the contemplated variations in physical
physical state (e.g., Solid, liquid, gas or dispersion) that is states (e.g., Solid, liquid, gas and dispersion) of the active
different from the physical state of the active ingredient(s) in 10 ingredient(s) selectively introduced within the receiving
receiving chambers 528b. Those skilled in the art will readily chambers 518 which are consistent with the spirit and scope
recognize other possible modifications and adaptations rela of the present invention. It is intended, therefore, that the
tive to the contemplated variations in physical states (e.g., figures and examples provided herein be viewed as exemplary
Solid, liquid, gas and dispersion) of the active ingredient(s) of the principles of the present invention, and not as restrictive
selectively introduced within the receiving chambers 528 15 to a particular structure or method for implementing those
which are consistent with the spirit and scope of the present principles.
invention. It is intended, therefore, that the figures and Referring now to FIG. 9, yet another presently preferred
examples provided herein be viewed as exemplary of the embodiment of a multi-compartment capsule of the present
principles of the present invention, and not as restrictive to a invention, generally designated as 610, is shown comprising
particular structure or method for implementing those prin a primary capsule 611 and a secondary capsule 620 selec
ciples tively positionable within at least a portion of an internal
One presently preferred embodiment of an encapsulation periphery of the primary capsule. The primary capsule 611
process, as defined by the structural configuration of the having a receiving chamber 618 preferably formed having an
multi-compartment capsule 510, may comprise the steps of internal periphery sufficient for receiving the secondary cap
(1) introducing one or more active ingredients or medica 25 sule 620, together with one or more active ingredients or
ments (e.g., pharmaeceutical, biotechnical, nutraceutical, medicaments (e.g., pharmaeceutical, biotechnical, nutraceu
Vitamin, dietary Supplement, mineral or combination thereof) tical, vitamin, dietary Supplement, mineral or combination
into receiving chamber 518e defined by dividing walls 516d. thereof) therein. The secondary capsule 620 comprising a
516e which are disposed vertically along the length of the capsular base 624 preferably configured having an elongated
elongated body of the base 514; (2) introducing a secondary 30 or longitudinally extending body, a corresponding cap 622
capsule 520 into receiving chamber 518d defined by dividing and a plurality of dividing walls 626 selectively disposed
walls 516c, 516d which are disposed vertically along the along the length of the longitudinally extending body of the
length of the elongated body of the base 514; (3) introducing base, both horizontally and vertically. Instructural design, the
one or more active ingredients or medicaments (e.g., phar size, shape and positioning of the dividing walls 626a, 62.6b,
maeceutical, biotechnical, nutraceutical, Vitamin, dietary 35 626c. 626d along the length of the longitudinally extending
Supplement, mineral or combination thereof) into receiving body of the base 624 facilitate the formation of a plurality of
chamber 518c defined by dividing walls 516b,516c which are independent receiving chambers 628.
disposed vertically along the length of the elongated body of In one presently preferred embodiment, the dividing walls
the base 514; (4) introducing one or more active ingredients 626a, 626b, 626c. 626d. 626e are preferably disposed or
or medicaments (e.g., pharmaeceutical, biotechnical, nutra 40 seated in a spaced apart relationship within the internal
ceutical, Vitamin, dietary Supplement, mineral or combina periphery of the base 624 of the secondary capsule 620 along
tion thereof) into receiving chamber 518b defined by dividing the length of the longitudinally extending body, whereby
walls 516b, 516e which are disposed vertically along the forming five (5) independent receiving chambers 628a, 628b,
length of the elongated body of the base 514; (5) disposing 628c. 628d, 628e. Each receiving chamber 628a, 628b, 628c,
dividing wall 516a along the length of the elongated body of 45 628d, 628e of the secondary capsule 620 are preferably con
the base 514 perpendicular to the disposition of dividing walls figured having an internal periphery dimensionally sufficient
516b, 516c. 516d, 516e and introducing one or more active for receiving one or more active ingredients or medicaments
ingredients or medicaments (e.g., pharmaeceutical, biotech (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
nical, nutraceutical, vitamin, dietary Supplement, mineral or dietary Supplement, mineral or combination thereof) therein.
combination thereof) into receiving chamber 518a; and (6) 50 One presently preferred embodiment of an encapsulation
selectively positioning the cap 512 in sealing relationship process, as defined by the structural configuration of the
with the base 514 to form one presently preferred embodi multi-compartment capsule 610, may comprise the steps of
ment of a single, dosage multi-compartment capsule 510. As (1) introducing one or more active ingredients or medica
appreciated, the dividing wall 516a may also function in the ments (e.g., pharmaeceutical, biotechnical, nutraceutical,
formation of the sealing relationship between the base 514 55 Vitamin, dietary Supplement, mineral or combination thereof)
and the corresponding cap 512, if structurally desired. into receiving chamber 628e defined by dividing walls 626d.
As illustrated by way of example, and not by way of limi 626e which are vertically disposed along the length of the
tation, a solid may be selectively introduced into at least a elongated body of the base 624; (2) introducing one or more
portion of the internal periphery of receiving chamber 518a, active ingredients or medicaments (e.g., pharmaeceutical,
a dispersion may be selectively introduced into at least a 60 biotechnical, nutraceutical, vitamin, dietary Supplement,
portion of the internal periphery of receiving chamber 518b, mineral or combination thereof) into receiving chamber 628d
a liquid may be selectively introduced into at least a portion of defined by dividing walls 626c. 626d which are vertically
the internal periphery of the receiving chamber 518c and a disposed along the length of the elongated body of the base
liquid may be selectively introduced into at least a portion of 624; (3) introducing one or more active ingredients or medi
the internal periphery of the receiving chamber 518e. 65 caments (e.g., pharmaeceutical, biotechnical, nutraceutical,
Although the ingredient(s) introduced into one of the receiv Vitamin, dietary Supplement, mineral or combination thereof)
ing chambers 518 may be the same ingredient or may be into receiving chamber 628c defined by dividing walls 626b,
US 7,670,612 B2
37 38
626c which are vertically disposed along the length of the more active ingredients or medicaments (e.g., pharmaeceuti
elongated body of the base 624; (4) introducing one or more cal, biotechnical, nutraceutical, vitamin, dietary Supplement,
active ingredients or medicaments (e.g., pharmaeceutical, mineral or combination thereof) introduced within the inter
biotechnical, nutraceutical, vitamin, dietary Supplement, nal periphery of the receiving chamber 718, wherein the
mineral or combination thereof) into receiving chamber 628b active ingredient(s) introduced into the primary capsule com
defined by dividing walls 626b, 626e which are vertically prises a physical state (e.g., Solid, liquid, gas or dispersion)
disposed along the length of the elongated body of the base which differs from the physical state of the active
624; (5) disposing dividing wall 626a along the length of the ingredient(s) introduced into the internal periphery of the
elongated body of the base 624 perpendicular to the disposi secondary capsule. In structural design, the primary capsule
tion of dividing walls 626b, 626c. 626d. 626e and introducing 10 711 further comprises a cap 712 having a generally U-shaped
one or more active ingredients or medicaments (e.g., phar configuration adapted to provide a sealing relationship when
maeceutical, biotechnical, nutraceutical, Vitamin, dietary engaging the corresponding base 714, thereby reducing dead
Supplement, mineral or combination thereof) into receiving space Volume in the internal periphery of the receiving cham
chamber 628a; (6) selectively positioning the cap 622 in ber 718 of the base. In this regard, the configuration of the cap
sealing relationship with the base 624 of the secondary cap 15 712 generally eliminates or substantially reduces the poten
sule 620; (7) introducing the secondary capsule 620 and one tial dead space volume within the internal periphery of the
or more ingredients or medicaments (e.g., pharmaeceutical, receiving chamber 718, thus functionally negating the oppor
biotechnical, nutraceutical, vitamin, dietary Supplement, tunity for reaction between an air bubble and the active ingre
mineral or combination thereof) into the receiving chamber dient(s) introduced into the base 714 of the primary capsule
618 of the primary capsule 611; and (8) selectively position 711.
ing the cap 612 in sealing relationship with the base 614 of the One presently preferred embodiment of an encapsulation
primary capsule 611 to form one presently preferred embodi process, as defined by the structural configuration of the
ment of a single, dosage multi-compartment capsule 610. multi-compartment capsule 710, may include the steps of: (1)
As illustrated by way of example, and not by way of restric introducing one or more active ingredients or medicaments
tion, a Solid may be selectively introduced into at least a 25 (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
portion of the internal periphery of the receiving chamber dietary Supplement, mineral or combination thereof) into
628a, a dispersion may be selectively introduced into at least receiving chamber 728; (2) selectively positioning the cap
a portion of the internal periphery of the receiving chamber 722 in sealing relationship with the base 724 of the secondary
628b, a liquid may be selectively introduced into at least a capsule 720; (3) introducing one or more active ingredients or
portion of the internal periphery of the receiving chamber 30 medicaments (e.g., pharmaeceutical, biotechnical, nutraceu
628c, a solid may be selectively introduced into at least a tical, vitamin, dietary Supplement, mineral or combination
portion of the internal periphery of the receiving chamber thereof), together with the secondary capsule 720, into the
628d and a liquid may be selectively introduced into at least receiving chamber 718 of the primary capsule 711; and (4)
a portion of the internal periphery of the receiving chamber selectively positioning the cap 712 having a general U-shaped
628e of the secondary capsule 620. In addition, a gas may be 35 configuration in sealing relationship with the base 714 of the
introduced into at least a portion of the internal periphery of primary capsule 711 to form a presently preferred embodi
the receiving chamber 618 of the primary capsule 611. ment of a single, dosage multi-compartment capsule 710.
Although the ingredient(s) introduced into one of the wherein eliminating or Substantially reducing dead space Vol
receiving chambers 618, 628 of the primary and secondary ume within the internal periphery of the receiving chamber
capsules, respectively, may be the same ingredient or may be 40 718.
different from the ingredient(s) introduced into the other A solid is selectively introduced within at least a portion of
receiving chambers, the active ingredient(s) in at least two of the internal periphery of the receiving chamber 728 of the
the receiving chambers 618, 628 preferably comprise a physi secondary capsule 720 and a liquid is selectively introduced
cal state (e.g., Solid, liquid, gas or dispersion) that is different within at least a portion of the internal periphery of the receiv
from the physical state of the active ingredient(s) in one or 45 ing chamber 718 of the primary capsule 711. Although the
more of the remaining receiving chambers. Those skilled in ingredient(s) introduced into the receiving chamber 718 of
the art will readily recognize other possible modifications and the primary capsule 711 may be the same or different from the
adaptations relative to the contemplated variations in physical ingredient(s) introduced into the receiving chamber 728 of
states (e.g., Solid, liquid, gas and dispersion) of the active the secondary capsule 720, the active ingredient(s) in the
ingredient(s) selectively introduced within the receiving 50 primary capsule have a physical state (i.e., Solid, liquid, gas or
chambers 618, 628 which are consistent with the spirit and dispersion) that various from the physical state of the active
scope of the present invention. It is intended, therefore, that ingredient(s) in the secondary capsule. Accordingly, those
the figures and examples provided herein be viewed as exem skilled in the art will readily recognize other possible modi
plary of the principles of the present invention, and not as fications and adaptations relative to the contemplated varia
restrictive to a particular structure or method for implement 55 tions in physical states of the active ingredient(s) selectively
ing those principles. introduced within the receiving chambers 718, 728 of the
Another presently preferred embodiment of a multi-com primary and secondary capsules 711, 720, respectively,
partment capsule of the present invention, generally desig which are consistent with the spirit and scope of the present
nated as 710 in FIG. 10, is shown comprising a secondary invention. It is intended, therefore, that the figures and
capsule 720 including one or more active ingredients or medi 60 examples provided herein be viewed as exemplary of the
caments (e.g., pharmaeceutical, biotechnical, nutraceutical, principles of the present invention, and not as restrictive to a
Vitamin, dietary Supplement, mineral or combination thereof) particular structure or method for implementing those prin
within at least a portion of the internal periphery of a receiv ciples.
ing chamber 728 and having a size and shape sufficient for Referring now to FIGS. 11 and 12, yet another presently
being selectively introduced within at least a portion of the 65 preferred embodiment of a multi-compartment capsule 810
internal periphery of a receiving chamber 718 of a primary of the present invention is shown comprising a secondary
capsule 711. The primary capsule 711 also includes one or capsule 820 including one or more active ingredients or medi
US 7,670,612 B2
39 40
caments (e.g., pharmaeceutical, biotechnical, nutraceutical, cament(s) within the receiving chamber 818 of the primary
Vitamin, dietary Supplement, mineral or combination thereof) capsule, while preserving the overall rounded shape of the
within at least a portion of the internal periphery of a receiv multi-compartment capsule 910 for ease of Swallowing by a
ing chamber 828. The secondary capsule 820 being prefer COSU.
ably formed having a size and shape Sufficient for being As best illustrated in FIG. 12, one presently preferred
selectively introduced within at least a portion of the internal embodiment of an encapsulation process, as defined by the
periphery of a receiving chamber 818 of a primary capsule structural configuration of the multi-compartment capsule
811. Similarly, the primary capsule 811 includes one or more 810, may include the steps of: (1) introducing one or more
active ingredients or medicaments (e.g., pharmaeceutical, active ingredients or medicaments (e.g., pharmaeceutical,
biotechnical, nutraceutical, vitamin, dietary Supplement, 10 biotechnical, nutraceutical, vitamin; dietary Supplement,
mineral or combination thereof) introduced within the inter mineral or combination thereof) into at least a portion of the
nal periphery of the receiving chamber 818, together with the receiving chamber 828; (2) selectively positioning the cap
secondary capsule 820, wherein the active ingredient(s) intro 822 in sealing relationship with the base 824 of the secondary
duced into the primary capsule comprises a physical state capsule 820; (3) introducing one or more active ingredients or
(e.g., Solid, liquid, gas or dispersion) which differs from the 15 medicaments (e.g., pharmaeceutical, biotechnical, nutraceu
physical state of the active ingredient(s) introduced into the tical, vitamin, dietary Supplement, mineral or combination
internal periphery of the secondary capsule 820. thereof), together with the secondary capsule 820, into at least
In preferred structural design, the primary capsule 811 a portion of the receiving chamber 818 of the primary capsule
comprises a cap 812 having a general cylindrical configura 811; (4) introducing a filling material 840 into at least a
tion adapted to provide a sealing relationship when engaging portion of the internal periphery of the cap 812 (i.e., filling the
the corresponding base 814 to form a single dosage, multi cap); and (5) selectively positioning the cap 812 having a
compartment capsule 810. An amount of filling material 840 general conical configuration in Sealing relationship with the
may be introduced into the internal periphery of the cap 812 base 814 of the primary capsule 811 to form one presently
to fill, either partially or completely, the inner volume of the preferred embodiment of a single, dosage multi-compartment
cap, thereby reducing the dead space Volume in the internal 25 capsule 810, wherein eliminating or Substantially reducing
periphery of the receiving chamber 818 of the base. In this dead space Volume within the internal periphery of the cap
regard, the configuration of the addition of the filler material 812 and the receiving chamber 818, respectively.
840 relative to the internal periphery of the cap 812 generally A solid may be selectively introduced within at least a
eliminates or Substantially reduces the potential dead space portion of the internal periphery of the receiving chamber 828
volume within the internal periphery of the receiving cham 30 of the secondary capsule 820 and a liquid may be selectively
ber 818, thus functionally negating the potential for a reaction introduced within at least a portion of the internal periphery of
between an air bubble and the active ingredient(s) introduced the receiving chamber 818 of the primary capsule 811.
into the base 814 of the primary capsule 811. Although the ingredient(s) introduced into the receiving
Preferably, the filling material 840 introduced into at least chamber 818 of the primary capsule 811 may be the same or
a portion of the internal periphery of the cap 812 may include 35 different from the ingredient(s) introduced into the receiving
a hydrophilic polymer, such as gelatin. It will be readily chamber 828 of the secondary capsule 820, the active ingre
appreciated by those skilled in the art that other filling mate dient(s) in the primary capsule have a physical state (i.e.,
rials may be used, such as, for example, starch, casein, chi Solid, liquid, gas or dispersion) that various from the physical
tosan, Soya bean protein, safflower protein, alginates, gellan state of the active ingredient(s) in the secondary capsule.
gum, carrageenan, Xanthan gum, phtalated gelatin, Succi 40 Accordingly, those skilled in the art will readily recognize
nated gelatin, cellulosephtalate-acetate, polyvinylacetate, other possible modifications and adaptations relative to the
hydroxypropyl methyl cellulose, (HPMC), oleoresin, polyvi contemplated variations in physical states of the active ingre
nylacetate-phtalate, polymerisates of acrylic or methacrylic dient(s) selectively introduced within the receiving chambers
esters, and mixtures thereof, or the like, and/or combinations 818, 828 of the primary and secondary capsules 811, 820,
thereof. In other presently preferred embodiments of the 45 respectively, which are consistent with the spirit and scope of
present invention, the filling material 840 may include the the present invention. It is intended, therefore, that the figures
introduction of an inert compound, for example, nitrogen gas and examples provided herein be viewed as exemplary of the
into at least a portion of the internal periphery of the cap 812. principles of the present invention, and not as restrictive to a
Based on the principals of eliminating or reducing the Volume particular structure or method for implementing those prin
dead space in multi-compartment capsules disclosed herein, 50 ciples.
those skilled in the art will readily recognize other possible Referring now to FIG. 13, another presently preferred
modifications and combinations which are consistent with the embodiment of a multi-compartment capsule, generally des
spirit and scope of the present invention. It is intended, there ignated at 910, is shown comprising a tertiary capsule 930
fore, that the examples provided herein be viewed as exem including one or more active ingredients or medicaments
plary of the principles of the present invention, and not as 55 (e.g., pharmaeceutical, biotechnical, nutraceutical, vitamin,
restrictive to a particular structure or process for implement dietary Supplement, mineral or combination thereof) within
ing those principles. at least a portion of the internal periphery of a receiving
The filling material 840 introduced within at least a portion chamber 938 and having a size and shape sufficient for being
of the internal periphery of the cap 812 of the primary capsule introduced into the internal periphery of a receiving chamber
811 is generally intended to promote a binding contact with at 60 928 of a secondary capsule 920. The secondary capsule 920
least a portion of the cap 822 of the secondary capsule 820, having one or more active ingredients or medicaments (e.g.,
thereby seating at least a portion of the secondary capsule pharmaeceutical, biotechnical, nutraceutical, Vitamin,
within the cap of the primary capsule and forming a molded dietary Supplement, mineral or combination thereof) intro
appearance. As appreciated, the introduction of the filling duced within at least a portion of the internal periphery of a
material 840 into the cap 812 of the primary capsule 811 prior 65 receiving chamber 928, together with the tertiary capsule 930.
to the joining and sealing process may prevent the opportu The secondary capsule 920 preferably formed having a size
nity for a reaction between an air bubble and the active medi and shape sufficient for being selectively introduced within at
US 7,670,612 B2
41 42
least a portion of the internal periphery of a receiving cham mary capsule, while preserving the overall rounded shape of
ber 918 of a primary capsule 911. Similarly, the primary the multi-compartment capsule 910 for ease of swallowing by
capsule 911 may include one or more active ingredients or a COSU.
medicaments (e.g., pharmaeceutical, biotechnical, nutraceu As best illustrated in FIG. 13, one presently preferred
tical, vitamin, dietary Supplement, mineral or combination embodiment of an encapsulation process, as defined by the
thereof) introduced within the internal periphery of the structural configuration of the multi-compartment capsule
receiving chamber 818, together with the secondary capsule 910, may include the steps of: (1) introducing one or more
920 which houses the tertiary capsule 930. In one presently active ingredients or medicaments (e.g., pharmaeceutical,
preferred embodiment, the active ingredient(s) introduced biotechnical, nutraceutical, vitamin, dietary Supplement,
into the secondary capsule 920 comprises a physical state 10 mineral or combination thereof) into at least a portion of the
(e.g., Solid, liquid, gas or dispersion) which differs from the receiving chamber 938 of a tertiary capsule 930; (2) selec
physical state of the active ingredient(s) introduced into the tively positioning the cap 932 in sealing relationship with the
internal periphery of the primary capsule 911 and the internal base 934 of the tertiary capsule 930; (3) introducing one or
periphery of the tertiary capsule 930. more active ingredients or medicaments (e.g., pharmaeceuti
In preferred structural design, the primary capsule 911
15 cal, biotechnical, nutraceutical, vitamin, dietary Supplement,
comprises a cap 912 having a general cylindrical configura mineral or combination thereof), together with the tertiary
tion adapted to provide a sealing relationship when engaging capsule 930, into at least a portion of the receiving chamber
928 of the secondary capsule 920; (4) selectively positioning
the corresponding base 914 to form a single dosage, multi the cap 922 in sealing relationship with the base 924 of the
compartment capsule 910. An amount of filling material 940 secondary capsule 920; (5) introducing one or more active
may be introduced into at least a portion of the internal ingredients or medicaments (e.g., pharmaeceutical, biotech
periphery of the cap 912 to fill, either partially or completely, nical, nutraceutical, vitamin, dietary Supplement, mineral or
the inner Volume of the cap, thereby reducing the dead space combination thereof), together with the secondary capsule
Volume in the cap and the internal periphery of the receiving 920, into at least a portion of the receiving chamber 918 of the
chamber 918 of the base. In this regard, the configuration of 25 primary capsule 911; (6) introducing a filling material 940
the addition of the filler material 940 relative to the internal
periphery of the cap 912 may generally eliminate or substan into at least a portion of the internal periphery of the cap 912
(i.e., preferably filling the cap); and (7) selectively position
tially reduce the potential dead space volume within the inter ing the cap 912 having a general conical configuration in
nal periphery of the receiving chamber 918, thus functionally seating relationship with at least a portion of the secondary
negating the potential for a reaction between an air bubble and 30 capsule 920 and sealing the base 914 of the primary capsule
the active ingredient(s) introduced into the base 914 of the 911 to form one presently preferred embodiment of a single,
primary capsule 911. dosage multi-compartment capsule 910, wherein eliminating
Preferably, the filling material 940 introduced into at least or Substantially reducing dead space Volume within the inter
a portion of the internal periphery of the cap 912 may include nal periphery of the cap 912 and the receiving chamber 918,
a hydrophilic polymer, such as gelatin. It will be readily 35 respectively.
appreciated by those skilled in the art that other filling mate A solid may be introduced within at least a portion of the
rials may be used, such as, for example, starch, casein, chi internal periphery of the receiving chamber 938 of the tertiary
tosan, Soya bean protein, safflower protein, alginates, gellan capsule 930, a liquid may be introduced into at least a portion
gum, carrageenan, Xanthan gum, phtalated gelatin, Succi of the internal periphery of the secondary capsule 920 and a
nated gelatin, cellulosephtalate-acetate, polyvinylacetate, 40 solid may be selectively introduced within at least a portion of
hydroxypropyl methylcellulose, oleoresin, polyvinylacetate the internal periphery of the receiving chamber 918 of the
phtalate, polymerisates of acrylic or methacrylic esters, and primary capsule 911. Although the ingredient(s) introduced
mixtures thereof, or the like, and/or combinations thereof. In into the receiving chambers 918, 928,938 of the primary,
other presently preferred embodiments of the present inven secondary and tertiary capsules 911, 920, 930, respectively,
tion, the filling material 940 may include the introduction of 45 may be the same or different from the ingredient(s) intro
an inert compound, for example, nitrogen gas into at least a duced into the other receiving chambers, the active
portion of the internal periphery of the cap 912. Based on the ingredient(s) in at least two of the receiving chambers 918,
principals of eliminating or reducing the Volume dead space 928,938 have different physical states (i.e., solid, liquid, gas
in multi-compartment capsules disclosed herein, those or dispersion). Those skilled in the art will readily recognize
skilled in the art will readily recognize other possible modi 50 other possible modifications and adaptations relative to the
fications and combinations which are consistent with the contemplated variations in physical states of the active ingre
spirit and scope of the present invention. It is intended, there dient(s) selectively introduced within the receiving chambers
fore, that the examples provided herein be viewed as exem 918,928,938 of the primary, secondary and tertiary capsules
plary of the principles of the present invention, and not as 911, 920, 930, respectively, which are consistent with the
restrictive to a particular structure or process for implement 55 spirit and scope of the present invention. It is intended, there
ing those principles. fore, that the figures and examples provided herein be viewed
The filling material 940 introduced within at least a portion as exemplary of the principles of the present invention, and
of the internal periphery of the cap 912 of the primary capsule not as restrictive to a particular structure or method for imple
911 is generally intended to promote a binding contact with at menting those principles.
least a portion of the cap 922 of the secondary capsule 920, 60 Generally referring to FIGS. 1-13, the component parts of
thereby seating at least a portion of the secondary capsule the presently preferred embodiments of the multi-compart
within the cap of the primary capsule and forming a molded ment capsules (i.e., capsular base, corresponding cap and
appearance. As appreciated, the introduction of the filling dividing walls) of the present invention may comprise a
material 940 into the cap 912 of the primary capsule 911 prior hydrophilic polymer, such as gelatin (marine or animal based
to the joining and sealing process tends to prevent the oppor 65 product). Other Suitable materials forming the capsules may
tunity for a reaction between an air bubble and the active include starch, casein, chitosan, Soya bean protein, safflower
medicament(s) within the receiving chamber 918 of the pri protein, alginates, gellan gum, carrageenan, Xanthan gum,
US 7,670,612 B2
43 44
phtalated gelatin, Succinated gelatin, cellulosephtalate-ac and the secondary capsule) may be in the range of about 0 mm
etate, polyvinylacetate, hydroxypropyl methyl cellulose to 0.5 mm, whereas the outer capsular walls of the secondary
(HPMC), oleoresins, polyvinylacetate-phtalate, polymeri capsule or tertiary capsule may be in actual contact with the
sates of acrylic or methacrylic esters, and mixtures thereof, or inner capsular walls of the primary capsule or secondary
the like, and/or combinations thereof. The material compris capsule, respectively. As appreciated, in an effort to structural
ing the capsular components may further include between facilitate independent receiving chambers on opposing sides
about 0% to 40% of pharmaeceutically acceptable plasticiz of a dividing wall introduced within the internal periphery of
ers based upon the weight of the hydrophilic polymer. Plas a base of a capsule, the perimeter of the dividing wall prefer
ticizers that may be employed include, for example and not by ably engages the inner capsular walls of the capsule to pro
way of limitation, polyethylene glycol, glycerol, Sorbitol, 10 vide a sealing relationship therebetween.
dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl cit As further contemplated herein, the inner capsular walls of
rate, 1,2-propyleneglycol, mono-acetates, di-acetates, or tri a primary capsule may be treated with an adhesive sufficient
acetates of glycerol, mixtures thereof, or the like, and/or to improve engagement between the primary capsule and the
combinations thereof. As appreciated, plasticizers may also outer capsular walls of a secondary capsule. A suitable tech
be used in the development of a soft elastic shell, often 15 nique to apply an adhesive may be by way of spraying the
referred to as a soft gelatin capsule or “soft gel capsule, for same on the shells and capsules immediately before assem
a primary capsule, a secondary capsule and/or a tertiary cap bling the same. Suitable adhesives that may be used may
Sule. include, for example, tackidex, an aqueous gelatin solution,
The capsular shell material may contain pharmaeceutically or the like.
acceptable lubricants in the range of about 0% to 10%, based The primary, secondary or tertiary capsules, in accordance
upon the weight of the hydrophilic polymer. Lubricants that with the present invention, may be formed having the same or
may be used include, for example and not by way of limita different colors. Moreover, the base and corresponding cap of
tion, aluminum Stearate, calcium Stearate, magnesium Stear a single capsule may be formed having different colors in an
ate, tin Stearate, talc, Sodium lauryl Sulfate, lecithins, mineral effort to enhance the aesthetics of the capsule to the consumer.
oils, Stearic acid, silicones, mixtures thereof, or the like, and/ 25 In one presently preferred embodiment of a multi-compart
or combinations thereof. One presently preferred embodi ment capsule of the present invention, the dosage may be
ment of the multi-compartmental capsules of the present banded, sealed or easily dividable in a contact area of the
invention (e.g., primary capsule, secondary capsule, tertiary primary and secondary capsules or the sealing band may be
capsule, etc.) may include, for example, LICAPSR) capsules color-coded to assist in branding, if desired.
(for poorly soluble compounds), VCAPSTM capsules (made 30 It is further contemplated herein that a multi-compartment
from cellulosic raw materials), CONI-SNAPR) capsules and capsule of the present invention may comprise component
PRESS-FITR) capsules which are all presently manufactured parts of the capsule having various time-release coatings to
by Capsugel, a subsidiary of Pfizer, Inc. facilitate the release and ultimately the absorption of those
In one presently preferred embodiment of an encapsulation active ingredients introduced into the different receiving
process, the primary capsule may be kept under conditions of 35 chambers of the multi-compartment capsule to release at
low humidity within a filling machine during the contem different release rates. In particular, a primary capsule may be
plated steps of rectifying and assembling. In certain embodi formed having a conventional time-release coating that dis
ments, the primary capsule may contain moisture content in Solves and releases the active ingredient(s) contained therein
the range of approximately 0% to 6% of the total weight. before the timed-release of the active ingredient(s) contained
Similarly, a secondary capsule, a tertiary capsule, etc. may be 40 within a secondary capsule. Likewise, the dividing walls dis
processed in the same manner as the primary capsule relative posed within the internal periphery of the base of a capsule
to conditions of low humidity during the steps of rectifying may be formed having conventional time-release coatings
and assembling. As contemplated herein, a moisture content that dissolve and release the active ingredients within each
of approximately 0% to 3% by weight is preferable. However, receiving chamber defined by the dividing walls at different
capsules having a higher moisture content than those stated 45 rates, thereby delivering the active ingredients or medica
herein are certainly not outside the spirit and scope of the ments contained within a multi-compartment capsule at dif
present invention. ferent rates. Certain active ingredients or medicaments may,
As illustrated in FIGS. 1-9 and 11-13, the shape of the base therefore, be delivered at a selected interval, while other
and corresponding cap of the capsules (e.g., primary, second ingredients may be released at a later interval. In this way, the
ary, tertiary, etc.) of the presently preferred embodiments of 50 novel design of the multi-compartment capsules of the
the multi-compartment capsules are configured having agen present invention may facilitate precision delivery of active
eral cylindrical shape which defines a diameter and length ingredients to targeted areas of the consumer.
sufficient for the introduction of an internal smaller capsule or The disclosure of secondary and tertiary capsules may be
one or more dividing walls along the length of the capsular replaced with other forms of microencapsulation. Microen
base. It is apparent that other geometrical configurations of 55 capsulation, as previously described, refers to the process
the cap are likewise Suitable and contemplated herein, such as whereby minute parcels of a Solid, liquid, gas or dispersion,
the general U-shaped configuration of the cap shown in FIG. introduced into one or more of the receiving chambers as
10. It is intended, therefore, that the examples provided herein active ingredient(s), are film-coated with a secondary mate
be viewed as exemplary of the principles of the present inven rial in order to shield the active ingredient from its surround
tion, and not as restrictive to any particular structure or con 60 ing environment. Microcapsules may measure from microns
figuration for implementing those principles. to several millimeters, whereas the main purpose being to
In one presently preferred embodiment, the clearance facilitate the release of the active ingredients at different
between the primary capsule and the secondary capsule intro release rates.
duced within the internal periphery of the primary capsule is The incorporation of time-release coatings to varying the
preferably greater than +0.2 mm. The clearance between the 65 release rates of the active ingredients of a multi-compartment
outer capsular walls of the secondary capsule and the inner capsule may be used to target key time intervals or events
capsular walls of the primary capsule (or the tertiary capsule when the body may be most able to utilize the active ingre
US 7,670,612 B2
45 46
dients. In one presently preferred embodiment of the present stabilize the liquids, Solids or dispersions using a lipid, lipoid,
invention, all of the active ingredients may be microencapsu lecithin, ghee or the like. Still further by example, in some
lated. In alternate presently preferred embodiments, only cases involving active ingredients or medicaments with poor
selected ingredients may be microencapsulated for delayed bioavailability, bioeduivalence, or other undesirous pharmae
release, while other ingredients may be provided for imme ceutical properties (e.g., poor water solubility, pH lability,
diate absorption. Thus, the incorporation of time-release physical incompatibility, chemical incompatibility, macro
coatings in the encapsulation process when forming a multi
compartment capsule may be specifically designed to fit the molecular size and the like) Such as proteins (e.g., hormones,
needs and desires of numerous different users having similar erythropoeitins, colony stimulating factors, interferons, inter
conditions that are being targeted for treatment. 10 leukins, plasminogen activators, monoclonal antibodies, vac
As contemplated herein, the physical states of active ingre cines, plant proteins, such as soy and other therapeutic pro
dients are characterized into one of four different states (e.g., teins) or other non-polar or weak-polar materials, it may be
Solid, liquid, gas or dispersion). These four different states are desirous to complement the active ingredient or medicament
Sometimes referred to as “phases” (i.e., Solid phase, liquid in liquid, Solid or dispersion form using a fat, lipid, lipoid,
phase, gas phase or dispersion phase). For purposes of the 15
lecithin, ghee, polymers, viral and bacterial vectors and the
present invention, the term "solid is defined as including, by like.
way of example only and not by way of limitation, pills,
tablets, capsules (including both hard and soft elastic), pow It may be demonstrated that as medical and pharmacy
ders, granulation, flakes, troches (lozenges and pastilles), knowledge has continued to expand exponentially, new medi
Suppositories and semi-solid pastes, ointments, emulsions or caments, new classes of medicaments and new delivery tech
creams. The term “liquid” is defined as including, by way of nologies are becoming available for use in animals and
example only and not by way of limitation, Solutions, spirits, humans who experience particular medical diseases, illnesses
elixirs, sprays, syrups or fluid extracts. The term “dispersion' or conditions. A disease, illness, or condition may affect one
is defined as including, by way of example only and not by or more organ systems in an animal or human. Organ systems
way of limitation, aerosols (liquid or Solid in gas), Suspen 25
may include, for example: (1) autonomic, (2) cardiovascular,
sions (Solid in liquid), emulsions (liquid in liquid), foams (gas (3) neurological, (4) gastro-intestinal, (5) respiratory, (6)
in liquid), Solid foams (Solid in gas) or gels (liquid or Solid in renal system, (7) psychiatric, (8) endocrine, (9) gynecologic,
solid). (10) urologic, (11) immunologic, (12) bone and joint systems,
The active ingredients or medicaments introduced into the
receiving chambers of the multi-compartment capsules of the 30 (13) ear, nose, and throat, (14) dermatologic, (15) hemato
present invention preferably comprise a pharmaeceutical, logic, (16) infectious defense and (17) nutrition and metabo
biotechnical, nutraceutical, vitamin, dietary supplement, lism. In an animal or human who may be suffering from one
mineral or combination thereof For purposes of the present disease, illness or condition, it is common to also be suffering
invention, the term “pharmaeceutical' is defined as any sub from a disease, illness or condition affecting one or more of
stance that affects the structure or functioning of a living 35 the other organ system(s). These concomitant diseases, ill
organism. Pharmaeceuticals, sometimes referred to as nesses or conditions occurring within a single animal or
'drugs are widely used for the prevention, diagnosis and human are often labeled as "co-morbidities, a term often
treatment of diseases and for the relief of symptoms. The term shortened and referred to as "co-morbid.”
“biotechnical is defined as any substance that is derived from New medicaments and delivery technologies are providing
a biotechnology process. Biotechnology, sometimes short 40
patients and their health care practitioners with unprec
ened to “biotech', is the development oftechniques and meth edented therapeutic options in managing diseases, illnesses
ods (e.g., genetic engineering, protein engineering, genom
ics, proteomics, monoclonal antibody production, and conditions. In spite of this sophistication, there has been
polymerase chain reaction, transgenics and the like) for the no effort to develop new methods of using fixed combinations
application of biological processes to the production of mate 45 of medicaments for therapy of co-morbid diseases, illnesses
rials of use in medicine, foods, nutrition and industry. The or conditions. Moreover, there has been no effort to develop
term “nutraceutical' is defined as any substance that is a food new methods of using fixed combinations of medicaments for
of a part of a food and provides medical or health benefits, management of a single disease, illness or condition affecting
including the prevention and treatment of disease. The term one or more organ system(s). The aforementioned fixed com
“vitamin' is defined as any of various organic Substances or 50 binations may include a plurality of medicaments, which may
compounds that are essential for the normal processes of be newly discovered and developed, or have been known for
growth and maintenance (e.g., essential for energy transfor Sometime or some combination of medicaments thereof. In
mation and regulation of metabolism) of the body which are any regard, said fixed combinations have not previously been
present in natural foodstuffs or sometimes produced within contemplated in the art.
the body. The term "dietary supplement' is defined as any 55
The following examples will illustrate the invention in
product (other than tobacco) intended to supplement the diet further detail. It will be readily understood that the various
that bears or contains one or more of the following dietary active ingredients or medicaments that may be introduced
ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other into the receiving chambers of the multi-compartment cap
botanical: (D) an amino acid; (E) a dietary Substance for Sules of the present invention, as generally described and
Supplementing the diet by increasing the total dietary intake; 60
or (F) a concentrate, metabolite, constituent, extract or com illustrated in the Examples herein, are to be viewed as exem
bination of any ingredient described in (A), (B), (C), (D), or plary of the principles of the present invention, and not as
(E) hereinabove. If desired, excipients may also be introduced restrictive to a particular structure or process for implement
into one or more of the receiving chambers of the multi ing those principles. Thus, the following more detailed
compartment capsules of the present invention in addition to 65 description of the presently preferred embodiments of the
the active ingredient(s). For example, in Some cases involving methods, formulations, and compositions of the present
medicaments with poor water solubility, it may be desirous to invention, as represented in Examples I-XIV below, is not
US 7,670,612 B2
47 48
intended to limit the scope of the invention, as claimed, but is
merely representative of presently preferred embodiments of
the invention. Primary Capsule:
Example I Glucosamine HCI 500 mg
500-2000 mg/day
Chondroitin sulfate 400 mg
Glucosamine/Chondroitin (Solid) & Vitamin E 400-1600 mg/day
Secondary Capsule:
(Liquid)
10 Vitamin E 200 IU
As appreciated by those skilled in the art, arthritis is an 200-400 IU/day)
inflammatory condition typically affecting the synovia mem
branes and cartilage of joints. It has been estimated that as The incorporation of time-release coatings to varying the
many as one in three persons may experience symptoms release rates of the active ingredients (e.g., glucosamine HCl/
15 chondroitin Sulfate and vitamin E) in the primary and second
associated with arthritis during their lifetime. ary capsules, respectively, of the multi-compartment capsule
In addition to arthritis, various other chronic, debilitating may be used to target key time intervals or events when the
conditions may afflict the aged. Many of these conditions body may be most able to utilize the named active ingredients.
result from the natural process of aging in humans. The natu Thus, the incorporation of time-release coatings in the encap
ral aging process is partially due to the accumulation and Sulation process when forming a multi-compartment capsule
effects of toxic free-radical chemicals. Free-radicals result may be specifically designed to fit the needs and desires of
from several homeostatic biochemical processes. It is, numerous different users having similar conditions that are
accordingly, desirable to develop nutraceutical or dietary being targeted for treatment.
Supplement products which may alleviate multiple chronic, A therapeutically effective amount of glucosamine HCl/
25 chondroitin sulfate may be introduced into at least a portion of
debilitating conditions. It is also desirable to package and
administer Such products in the most economic and conve the internal periphery of the receiving chambers of a primary
nient possible fashion. capsule in the form of a solid and a therapeutically effective
The administration of glucosamine, a naturally occurring amount of vitamin E may be introduced into at least a portion
Substance in mucopoly-saccharides, mucoproteins and ofa secondary capsule in the form of a liquid, if desired. Since
chitin, is believed to promote the production of cartilage
30 the encapsulation process and multi-compartment, multi
components and the repair of damaged cartilage. Clinical phase capsule of the present invention are configured to apply
findings support that fibroblast cells increased production of to an anticipated treatment regime or medicinal design of a
single dosage capsule, it will be readily appreciated that the
mucopolysaccharide and collagen synthesis when glu introduction of one or more active ingredients into the receiv
cosamine was added. 35 ing chambers of the primary and secondary capsules, respec
Chondroitin Sulfates are large polymers of glycosami tively, is anticipated Such that the various ingredients may be
noglycans, primarily D-glucuronic acid and D-acetylgalac introduced in different receiving chambers to accommodate
tosamine, and disaccharides and may be derived from the different treatment modalities. For example, a multi-com
cartilage of bovine trachea. The administration of chondroitin partment capsule may be formulated having glucosamine
40
sulfate has been shown to promote the formation of new HCl and chondroitin sulfate introduced into the receiving
cartilage matrix. In particular, chondroitin Stimulates the chambers of the secondary capsule and vitamin E may be
metabolism of chondrocyte cells and the production of col introduced into the receiving chamber of the primary capsule.
lagen and proteoglycan. It is intended, therefore, that the examples provided herein be
Vitamin E, also known as alpha-tocopherol, is a well viewed as exemplary of the principles of the present inven
45 tion, and not as restrictive to a particular structure or method
known scavenger of free-radicals in the body. Free-radical for implementing those principles.
Scavengers are sometimes referred to as anti-oxidants. This
Scavenging process is important for detoxifying the body of Example II
chemicals which are known to promote apoptosis, or pro
grammed cell death. Apoptosis is a scientific description of 50 S-adenosylmethionine (SAMe) (solid) & Vitamin E
cellular destruction. Although vitamin E is a popular anti (liquid)
oxidant, it is poorly soluble in water and thus can be admin
istered only as a liquid-oil formulation or in an oil formulation S-adenosylmethionine (SAMe), may be derived from two
enclosed in a soft elastic capsule. materials: methionine, a Sulfur-containing amino acid, and
In one presently preferred embodiment of the present 55 adenosine triphosphate (ATP), the body's main energy com
invention, therapeutically effective amounts of glucosamine, pound. SAMe was originally developed around 1950 as an
chondroitin, and vitamin E (active ingredients) may be intro antidepressant. Over the years, it has also been found that
duced into receiving chambers of a multi-compartment cap SAMe may assist in alleviating arthritic symptoms, assist in
the manufacture of melatonin, which is needed to regulate
sule wherein at least two of the active ingredients have physi 60 sleep, help protect DNA from harmful mutations and prevent
cal states (e.g., Solid, liquid, gas or dispersion) that differ. certain types of nerve damage.
Consistent with the foregoing, multi-compartment, multi As noted above, vitamin E is a popular anti-oxidant, but it
phase capsules and encapsulation technology are herein con is poorly soluble in water and therefore can be administered
templated to produce a delivery vehicle for delivering anti only as a liquid-oil formulation. Vitamin E is typically mea
arthritic and anti-oxidant compounds to the body in a single 65 sured in international units (IU) of alpha tocopherol.
dosage. A capsular format of the present invention may In one presently preferred embodiment of the present
include the following composition: invention, therapeutically effective amounts of SAMe and
US 7,670,612 B2
49 50
Vitamin E (active ingredients) may be introduced into receiv preferred embodiment of the present invention thus makes for
ing chambers of a multi-compartment capsule wherein SAMe a more convenient dosage form.
comprises a physical state (e.g., Solid, liquid, gas or disper Since the encapsulation process and multi-compartment,
sion) different from the physical state of vitamin E. As shown multi-phase capsule of the present invention are configured to
in FIGS. 3 and 4, a therapeutically effective amount of SAMe apply to an anticipated treatment regime or medicinal design
may be introduced into receiving chamber 218a and a thera of a single dosage capsule, it will be readily appreciated that
peutically effective amount of vitamin E may be introduced the introduction of one or more active ingredients into receiv
into receiving chamber 218b of a multi-compartment capsule ing chambers defined within a capsule is anticipated Such that
210 of the present invention. Consistent with the foregoing, the various ingredients may be introduced in different receiv
multi-compartment, multi-phase capsules and encapsulation 10 ing chambers to accommodate different treatment modalities.
technology are herein contemplated to produce a delivery It is intended, therefore, that the examples provided herein be
vehicle for delivering mood enhancing, anti-arthritic and viewed as exemplary of the principles of the present inven
anti-oxidant compounds to the body in a single dosage. A tion, and not as restrictive to a particular structure or method
capsular format of the present invention may include the for implementing those principles.
following composition: 15
Example III
Extracts
Enzymes
25 Phospholipids
Alpha Galactosidase Amylase
Bromelain Cellulase
Papain Peptidase Lecithin Phosphatidyl Choline
Protease Proteolytic Enzymes Phosphatidyl Serine
Superoxide Dismutase Trypsin
Specialty Nutraceuticals
5-Hydroxytryptophan Acetyl L-Carnitine
Alpha Lipoic Acid Alpha-Ketoglutarates
Bee Products Betaine Hydrochloride
Bovine Cartilage Caffeine
Cetyl Myristoleate Charcoal
Chitosan Choline
Chondroitin Sulfate Coenzyme Q10
Collagen Colostrum
Creatine Cyanocobalamin (Vitamin B12)
DMAE Fumaric Acid
Germanium Sesquioxide Glandular Products
Glucosamine HCL Glucosamine Sulfate
HMB (Hydroxyl Methyl Butyrate) Immunoglobulin (Immune System Support)
Lactic Acid L-Carnitine
Liver Products Malic Acid
Maltose-anhydrous Mannose (d-mannose)
MSM Other Carnitine Products
Phytosterols Picolinic Acid
Pyruvate Red Yeast Extract
SAMe Selenium Yeast
Shark Cartilage Theobromine
Vanadyl Sulfate Welvet Deer Antler
Yeast
Herbal Oils
Aloe Vera Artichoke Oil
Artichoke Oil Black Currant Seed Oil 14% GLA
Black Currant Seed Oil 15% GLA Borage Oil 20% GLA
Borage Oil 22% GLA Boswellia Serrata Oil
CLA Conjugated Linolic Acid 75% min. Evening Primrose Oil 10% GLA
Evening Primrose Oil 9% GLA Flax Seed Oil 50% ALA
Garlic Oil Grape Seed Oil
Guggul Lipid Oil Olive Leak Extract
US 7,670,612 B2
71 72
-continued
Herbal Oils
Oregano Oil Perilla Oil 60% ALA
Pumpkin Seed Oil Pygeum Oil
Rosehip Oil Rosemary Oil
Saw Palmetto Oil Sterols
Tocotrienol Palm Oil Walnut Oil
Wheat Germ. Oil Sesame Seed Oil
Dil Seed Oil
Clove Bud Oil
Ginger Root Oil
Cinnamon Leaf Oil
Fennel Seed Oil
Curcuma Longa Oil
Cummin Seed Oil
Celery Seed Oil
Coriander Seed Oil
Red Rasberry Seed Oil
Cranberry Seed Oil
Blackberry Seed Oil
-continued
Marine Oils 25 Carotenoids
Cod Liver Oil (1000A/100 D) Cod Liver Oil (2500A/25OD) Carotenoids Lutein Lutein Esters
Fish Oil 30% EPA20% DHA Fish Oil Concentrated Lycopene Zeaxanthin
Fish Oil Deodorized Marine Lipid Oil 18/12
Marine Lipid Oil 30/20 Marine Lipid Oil 36/24
Salmon Oil 18% EPA 12% DHA Squalene Oil (Shark) 30
Hormones
7-Keto-DHEA Androstenedione
DHEA Melatonin
Nor-Androstenedione Pregnenolone
35 Progesterone 19 Nor-4-Androstendiol
Other Oils 19 Nor-4-Androstenedione
19 Nor-5-Androstenediol
Alpha Lipoic Acid Cetyl Myristoleate CM 19 Nor-5-Androstendione
Coenzyme Q10. Lecithin 3-Indolebutyric Acid
Medium Chain Triglycerides MCT. 4 Androstendiol
40 4 Androstendione
Vitamins
60
-continued
Carotenoids Hormones