CAPSULES

RPh Saba Inayat Ali

Lecturer
DCOP, DUHS

27.10.2016
CAPSULES
A capsule is a shell or a container prepared from gelatin
containing one or more medicinal and/or inert
substances.
The gelatin capsule shell may be soft or hard depending
on their formulation.
CAPSULES
Capsules are intended to be
swallowed whole by the patient.
In instances where patients
(especially children) are unable to
swallow capsules, the contents of
the capsule can be removed and
added (e.g., sprinkled) on soft food
immediately before ingestion. In
this case, capsules are used as a
vehicle to deliver premeasured
medicinal powder.
ADVANTAGES
Used in intact form
Avoids many steps involved in tablet manufacturing
Masking the taste and odor of drug
Materials that can not be compressed easily
Improve stability of the drug especially of those which
can not withstand at high pressure and temperature
Help reduced the issue of poorly soluble compounds
by allowing the development of liquid or semi solid
formulation (soft gelatin)
HARD GELATIN CAPSULES
HARD GELATIN CAPSULES
The majority of capsule products are made of
hard gelatin capsules
 Hard gelatin capsules are made of two shells:
the capsule body and
a shorter cap
The cap fits snugly over the open end of the
capsule body
The basic hard gelatin capsule shells are made
from mixtures of gelatin, sugar, and water.
Hard gel capsules are clear, colorless, and
essentially tasteless
GELATIN
 Gelatin is a product obtained by partial hydrolysis of collagen acquired
from the skin, white connective tissue, and bones of animals.
 Two types:
 Type A Gelatin
 Manufactured mainly from pork skin by acid treatment
 (pork skin, 1–5% HCl)
 Type B Gelatin
 Manufactured mainly from animal bones and skin by alkali treatment
 The product pH is adjusted between 4.7 and 5.3 or 7 and 9 depending
upon the type of gelatin used, and a hot water extraction is followed
by filtration, concentration, and solidification & dried.
 The final product is milled to size.
GELATIN
Gelatin is a protein which is soluble in warm (or hot)
water, but insoluble in cold water.
At low temperatures, gelatin dissolved in water becomes
a gel (which is insoluble in water). This property is used to
prepare Jello® and other gelatin deserts.
Gelatin capsules become dissolved in warm gastric fluid
and release the contents.
HARD GELATIN CAPSULES
Normally, hard gelatin capsules contain 13–16% of moisture.
If additional moisture is absorbed when stored in a high relative
humidity environment, hard gelatin capsule shell may lose their
rigid shape and become distorted.
In an opposite environment of extreme dryness, capsules may
become too brittle and may crumble during handling.
Since moisture can be absorbed by the gelatin capsules, capsules
and affect hygroscopic agents within, many capsules are packaged
in containers along with a desiccant.
Gelatin for making hard shells is of bone origin and has 220–280 g
bloom strength (the weight required to depress a standard plunger
4 mm into the gel).
 MANUFACTURING OF
HARD GELATIN CAPSULES
STEPS
Dipping
Spinning
Drying
Stripping
Trimming and joining
Polishing
Dipping
Pin bars are dipped in to the dipping
solution to simultaneously form the caps
and bodies
The desired thickness of coating is achieved
by controlling the time of coating
Dipping solution- 50oC in a heated jacketed
dipping pan
The pegs are made of manganese bronze.
Up to 500 pegs can be affixed to each plate.
Spinning
Pins are rotated to distribute the gelatin over the pins
uniformly and to avoid the formation of beads to
capsule ends
Drying
Gelatin is dried by a blast of cool air with controlled
temperature and humidity to form hard shells

Stripping
A series of bronze jaws strip the cap and body portions
of the capsules from the pins
Trimming and Joining
The stripped cap and body portions are
trimmed to the required length by stationary
knives
After trimming, the cap and body portions
are joined and ejected from the machine

Polishing
Encapsulation Step
Capsules lock
COLOURED AND OPAQUE CAPSULES
 capsule bodies and caps having different colors.
 FD&C and D&C dyes
 Opaque capsules
 titanium dioxide.
 By combining the various capsule parts with
different colors, distinctive capsules can be
prepared.
 This is important for those who have to take
more than one type of drugs in the capsule
dosage form.
 Different drugs in different capsules may be easily
distinguished by their colors of the capsules.
SIZE OF CAPSULES
Capsule shells are manufactured in various sizes, lengths,
diameters, and capacities.
For human use, capsules ranging in size from 000 (the
largest) to 5 (the smallest) are commercially available.
Table 3.1 lists the capacities of hard gelatin
capsules for human use
CAPSULE FORMULATION
 Diluents
 Lactose, MCC, starch
 Lubricants & Glidant
 Magnesium stearate
 Talc
 Disintegrant
 Sodium starch glycolate
 Wetting agents
 Wetting agents are used to enhance the dissolution of solid particles.
 Lithium carbonate
 Wetting agent prevents agglomeration of particles and accelerates the
dissolution of particles by allowing water to penetrate and replace air
between particles
 SOFT GELATIN CAPSULES

31.10.2016
SOFT GELATIN CAPSULES
Soft gelatin (also called softgel or soft
elastic) capsules consist of one-piece
hermetically-sealed soft shells.
Soft gelatin capsules are prepared by
adding a plasticizer, such as glycerin or
polyhydric alcohol (e.g., sorbitol), to
gelatin.
The plasticizer makes gelatin elastic.
SOFT GELATIN CAPSULES
contain non-aqueous liquids, suspensions, pasty
materials, or dry powders or even pre formed tablets

also contain volatile drug substances or drug materials

susceptible to deterioration in the presence of air
SOFT GELATIN CAPSULES
various shapes such
as spherical,
elliptical, oblong, and
special tube shapes
with and without
twist off
 SOFT GELATIN CAPSULES
COMPOSITION
1. Gelatin
 type B (alkaline treated) gelatin
2 . Plasticizers- glycerol*, sorbitol and polyethylene glycol
depending upon the compatibility.
Role of plasticizer is vital in soft gel formulations, approx.
20% of wet gel is plasticizer.
contributes to the final hardness of product
3. Water- Comprises of 30% - 40% of wet gel.
Water content of final product is typically 5% - 8%. Level
of water is important for good physical stability of final
product

4. Miscellaneous Excipients- Colorants, Opacifiers &

flavoring agents are occasionally used in low
concentrations
ADVANTAGES
Improved Drug Absorption
Patient compliance
Safety
Used for oils and low melting point drugs
Dose uniformity for low dose drugs
 Product stability
Softgels can be formulated and manufactured to
produce a number of Drug delivery systems
Orally administered soft gels
 solution or suspensions that release
their contents in stomach
Chewable soft gels
Highly flavored is chewed to release
the drug liquid fill matrix
Suckable soft gels
Gelatin shell containing the flavored
medicament to be sucked
Twist-off soft gels
Designed with a tag to be
twisted or snipped off, thereby
allowing access to the filled
material
Useful for unit dosing of
topical medication, inhalations
or oral dosing of a pediatric
product
 Meltable soft gels
Use as patient friendly
pessaries or suppositories
 MANUFACTURING OF
SOFT GELATIN CAPSULES
 Formulation of Soft Gel Fill Materials
Softgels are biphasic dosage form
 shell as solid phase and
 capsule fill matrix as liquid phase.
Selection of fill material depend upon
different physicochemical properties.
Selection is based on;
 Capacity to dissolve
 Rate of dispersion in gastrointestinal tract
 Capacity to retain the drug in solution in GIT
 Compatibility
 Ability to optimize the rate, extent and
consistency of drug absorbed
Formulation of Soft Gel Fill Materials
Fill Matrices Include
Lipophilic oils/liquid solution or suspensions;
e.g.triglyceride oils such as soya bean
 Hydrophilic liquids solution or suspensions. e.g. PEG
Microemulsions and nanoemulsions system
 Combination of lipophilic and hydrophilic liquids + surfactants
 After oral administration, disperse to form micro or nanoemulsion
ROTARY DIE ENCAPSULATION PROCESS
 Manufacturing and filling of soft gelatin capsules are done same time in
same machine
 Content of capsule is filled during manufacturing the shell
 Two separated gelatin ribbons are formed- casting method
 The two gel ribbons are then carried to the rollers
 Each gel ribbon provide one half of the soft gel
 the gelatin sheets are feed on rolls contain small orifice lined up with the
die pocket of the die roll
 liquid fill matrix along with unit dose drug filled between the rollers of the
rotary die mechanism where the capsule are simultaneously filled,
shaped, hermetically sealed and cut from the gelatin ribbon. The sealing
of the capsule is achieved by mechanical pressure on the die rolls and the
heating(37-40oC) of the ribbons by the wedge
The process involves careful control of 3
parameters
Temperature
Timing
Pressure
Formulation of Soft Gel Fill Materials
REFERENCE
Aulton’s Pharmaceutics, the design and manufacture of
medicines, 3rd edition, Ch# 35
Ansel’s Pharmaceutical Dosage form and drug delivery
systems, 8th edition, Ch# 7