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Preparations of Different 

Dosage Forms
Khent P. Alcantara, MSc RPh
Faculty
College of Pharmacy
+SOLUTIONS / Liquid
Dosage Forms
+
Solutions
■ Solutions
or Liquid Dosage forms
may be divided into two major
categories:

1. for internal
2. for external application.
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Internal Medications

■ Aqueous solutions
■ Elixirs

■ Syrups
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External Medications

■ Aerosols ■ Jellies
■ Gargles and ■ Collodion
mouthwashes
■ Douche
■ Sprays
■ Glycerites
■ Lotions
■ Enemas
■ Baths
■ Liniments
■ Ophthalmic preparation
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Pharmaceutical Aspects

■ Acid
– Base ■ Toxicity
property
■ Stability
■ Buffers

■ Isotonicity

■ Viscosity

■ Dissolution rate
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Acid-Base Properties

■ Drugs : weak acid or weak bases affecting the

solubility and causing possible incompatibility.
■ Strong acid releases its protons readily while weak
acid dissociates only slightly making it insoluble
or slightly soluble in water and salts of such are
soluble
■ Ex. Barbiturate salts cannot be prepared in
vehicles such as orange syrup or wild cherry
syrup, otherwise, the insoluble weak acids will
precipitate.
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Buffers
■ Solutions of a weak acid and its salts, a
weak base and its salts, or a protein
may act as buffers
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Buffers

■ Example:
■ If a base is added to a solution containing equimolar
concentrations of a weak acid and its salt, the base is
neutralized by the weak acid forming more of the salt
and the resulting increase in pH is only slight.

■ Commonly used buffer systems:

■ acetate – acetic acid, bicarbonate-carbonate,
borate-boric acid and Na2HPO4 – NaH2PO4
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Isotonicity 


■A compounder considers this

particular colligative property of a
drug as this would have an effect on
the osmotic pressure of a solution.
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Viscosity
Viscosity is a property of
liquids related to the
resistance to flow. The
reciprocal of viscosity is
fluidity.
■ The reciprocal of viscosity is
fluidity. Substances that flow
are known as Newtonian
substances and Non-Newtonian
substances for those that do not Viscosity values are
obey Newton’s equation of
flow. expressed in:
poise or centipoise
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Property of Viscosity
■ 1) This property is particularly
considered in the preparation of
macromolecular solutions (colloids,
syrups, glycerin-water systems).
■ (2) Viscosity also affects the formation
of insoluble compounds caused by
incompatibility in the system.
■ (3) It can also enhance therapeutic
effect
■ (4) it affects diffusion-dependent
process.
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TYPES OF VISCOMETER/
VISCOSIMETER

■ ROTATIONAL

■ gathers data on material’s viscosity behavior

under different conditions.

■ use for accurate measurement of viscosity for

both newtonian and non-newtonian fluids.

■ FALLING SPHERE/Ball

■ Based on Stokes’ Law consist of a circular

cylinder filled by liquid under investigation

■ A standard ball is allowed to fall down this

tube over a calibrated distance of 100 mm.
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TYPES OF VISCOMETER/
VISCOSIMETER

■ FALLING PISTON

■ based on the piston and cylinder

assembly.

■ piston is periodically raised by an air

lifting mechanism, drawing the
material being measured down
through the clearance (gap) between
the piston and the wall of the cylinder
into the space which is formed below
the piston as it is raised.
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TYPES OF VISCOMETER/
VISCOSIMETER
■ Vibrational Viscometer

■ used for continuous direct measurement

of viscosity in pipes and/or tanks

■ better suited to measure non-newtonian

liquids.

■ Oscillation Viscometer

■ used for small sample viscosity testing

in the laboratory.

■ it has also been adapted to measure

high pressure viscosity measurements
in both laboratory and process
environments.
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Dissolution Rate
■ This is important in determining the bioavailability
of the drug and problem regarding this is
dependent on factors such as:
1. Particle size
2. Viscosity of the solvent
3. Temperature
4. Mechanical agitation
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Toxicity

■ Particularly
considered in
preparing solution
during the
selection of
solvents or solvent
mixtures
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Stability

■ Stabilityof the active drug and the

preparation as a whole is considered.
Instability such as color fading, flavor
loss, cloudiness, precipitation, microbial
growth is retarded by the addition of
appropriate pharmaceutical
ingredients, dosage form,
compounding procedure and storage.
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ICH climatic zone and long term
stability condition
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Codes and Titles used in ICH
Guidelines
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Stability Test Storage Condition for
Drug Products
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`
• Each drug or chemical is dissolved
in the solvent in which it is most
soluble.
• If an alcoholic solution of a poorly
water soluble drug is used, the
aqueous solution is added to the
alcoholic solution.
• The salt form of the drug is used.
• Flavoring or sweetening agents
are prepared ahead.
• The proper vehicle must be selected.
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PARENTERAL
PRODUCTS
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PARENTERAL PRODUCTS

■ The extemporaneous
compounding of sterile
products is no longer
confined only to the
hospital environment;
it now is done by
community
pharmacists engaged
in home care practice.
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PARENTERAL

■ Should be FREE from PYROGEN

■ CHARACTERISTICS:

■ Clear; free from particulate matter

■ Sterile

■ Pyrogen FREE
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OFFICIAL TYPES OF INJECTIONS

■ INJECTION
■ Liquid preparation that are drug substances or solutions thereof.
■ FOR INJECTION
■ Dry solid with the addition of suitable vehicle that conforms to the
requirement of injection.
■ INJECTABLE EMULSION
■ Liquid preparation that are dissolved or dispersed in suitable emulsion
medium
■ INJECTABLE SUSPENSION
■ Liquid preparation dissolved or dispersed in liquid medium
■ FOR INJECTABLE SUSPENSION
■ Dry solid with the addition of vehicle, yields preparation conforming in all
respects to the requirement for injectable suspension.
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Vehicles use for INJECTIONS

■ Purified water, USP

■ Sterile Water for injection, USP
■ Bacteriostatic Water for injection, USP
■ Sodium Chloride Injection, USP

NON-AQUEOUS VEHICLE CAN ALSO BE USE IN

DILUTING PARENTERAL PRODUCTS
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Non-Aqueous - Vegetable and
Fixed oil
USP specification
•MUST remain clear when cooled to 10C to ensure the stability
and clarity during refrigeration
•MUST NOT contain paraffin and mineral oil (absorbed by body
tissues)
•MUST meet the officially stated requirement for iodine and
saponification value

Examples: CORN, CASTOR, SESAME, COTTONSEED, PEANUT,OLIVE

(hypersensitivity is common
MUST BE administer IM, NOT IV
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General requirements

1. Proper equipment and supplies

2. Proper facilities, including a laminar-flow
clean bench and a clean room or
isolation barrier technology equipment.
3. Proper documentation of all products
made.
4. Quality control, including batch sterility
testing
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General requirements

5. Proper storage both at the facility and in

transport to the patient’s home
6. Proper labeling of the prescription
product
7. Knowledge of product’s stability and
incompatibilities
8. Knowledge of all ancillary equipment
involved in production or delivery of the
medication.
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Preparation of Parenteral Products

1. Preparation of sterile products requires

special skills and training.
2. These products must be prepared in a
clean environment, using aseptic technique
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Preparation of Parenteral Products
3. Dry powders of parenteral drugs for
reconstitution are used for drug products
that are unstable as solutions.

4. Solutions of drugs for parenteral

administration may also be further diluted
before administration.
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METHODS OF STERILIZATION
■ STEAM

■ using autoclave under pressure.

■ DRY HEAT

■ using ovens which are heated using

electricity or gas.
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METHODS OF STERILIZATION

■ FILTRATION

■ physical removal of MO by
adsorption in the filter
medium.

■ GAS

■ for heat sensitive and

moisture sensitive materials
(ethylene oxide and
propylene oxide gas)

■ IONIZING RADIATION

■ using gamma rays and

cathode rays
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SUSPENSIONS
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Suspension

■ Suspensions are liquid preparations of

drugs containing finely divided drug
particles distributed uniformly throughout
the vehicle.

■ Suspensions appear cloudy in nature and

shaking is often required to re-suspend
drug particles that have settles.
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FEATURES OF A GOOD SUSPENSION

1. Should settle slowly and should be

readily redispersed upon gentle
shaking of the container.

2. The particle size of the “suspensoid”

should be fairly constant throughout
long period of undisturbed standing.

3. The suspension should pour readily

and evenly from its container.
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Suspension
■ Depending on particle size, some suspensions
settle so rapidly that a uniform dispersion cannot
be maintained long enough for an accurate dose
to be withdrawn. Such preparations require a
suspending agent, a thickening agent that gives
some structure to a suspension.
■ Typical agents are carboxymethylcellulose,
methylcellulose, bentonite, tragacanth, and
others.
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2 types of suspension
■Diffusible

These are suspensions containing light powders

that are insoluble, or only very slightly soluble, in the
vehicle but which on shaking disperse evenly
throughout the vehicle for long enough to allow an
accurate dose to be poured.

■Indiffusible
These are suspensions containing heavy powders
that are insoluble in the vehicle and which on shaking
do not disperse evenly throughout the vehicle long
enough to allow an accurate dose to be poured.
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A. Insoluble diffusible solids

■ freshprecipitates from a cold dilute

solution
■ micronized form
■ sufficiently small sized particles
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B. Insoluble, Indiffusible solids

1. Requires suspending agents (acacia,

tragacanth, methyl cellulose, glycerin,
bentonite and other clay products)
2. Factors considered for a good suspending
agent
■ The amount to be suspended
■ Volume of the prescription
■ Method for compounding
■ Possibility of incompatibility
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Suspending agents used

1. Acacia 10%

2. Sodium alginate 1-2%

3. Bentonite 6%

4. Tragacanth 1-3%

5. Carboxymethylcellulose 1-3%

6. Veegum 6%

7. Methylcellulose 1-7%
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Lotions
■ Lotions are liquid preparations intended
for external application.
■ The most common lotions are “shake”
lotions in which insoluble substances are
dispersed by agitation.
■ Often gums or other agents are used as
suspending agents to prevent rapid
settling of suspended particles.
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Emulsion
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Emulsions
■ Are dispersed system in which the
dispersed phase is composed of small
globules of a liquid distributed throughout a
vehicle in which it is immiscible

■ Two-phase system
■ May be used internally or externally
■ Requires an emulsifying agent
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Classifications of Emulsifying agents
■ Hydrophilic colloids – anionic, sensitive to high
concentrations of electrolyte and alcohol, greatly increases
the viscosity of the external phase, supports the growth of
microorganisms, requires preservative

■ Inorganic solids – particle sizes approaching colloidal

range.

■ Synthetic Emulsifying agent – ANIONIC ( carboxyl, sulfate,

sulfonate) CATIONIC (quaternary and pyridinium nitrogen)
NONIONIC (polyhydroxyl groups)

ANIONICS – monovalent, polyvalent and organic soaps

CATIONIC – benzalkonium Chloride

NONIONIC – Spans (1 - 9) Tweens ( 11 – 20)

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General formulation of Emulsions

1. Active ingredients 7. Sweeteners

2. Aqueous phase 8. Flavoring agent
3. Oleaginous phase 9. Colorant
4. Emulsifiers 10. Humectant
5. Antioxidant
6. Preservative
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Compounding of Emulsions
■ Procedure is dependent on the emulsifying agent to
be used
■ Know the order of mixing

1. DRY GUM (continental)

2. WET GUM (english)
3. BOTTLE METHOD
4. BEAKER METHOD
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Compounding of Emulsions

■ If
a preservative is to be used, it
should be water soluble to be
effective.
■ If
a flavor is to used, it should be
added to the external phase
before emulsification
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 Powdered
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Dosage Forms
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Powdered Dosage Forms

■ Intimate
mixtures of dry, finely divided
drugs and/or chemicals that may be
intended for internal or external use.

■ Used
when powders are too bulky to
make into capsules.
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TYPE OF POWDERS
BULK DIVIDED

AKA CHARTULA
GEOMETRIC
DRUG USED NON POTENT
DILUTION
BLOCK AND
PREPARATION INDIVIDUAL
DIVIDED
INDIVIDUALLY
DOSE NOT INDIVIDUAL
PACKED
WIDE MOUTH
PLASTICS OR
PACKING PAPER
GLASS BOTTLE,
SIFTER CANS
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TYPES OF PAPERS

■ White bond paper – it cannot protect drug

from moisture and cannot prevent
efflorescence
■ Glassine paper – minimal moisture
■ Vegetable parchment – thin semi opaque
paper with limited moisture resistance
■ Waxed paper – transparent and water proof
resistant paper
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Terms used in describing POWDERS

■ Hydroscopic – absorbs water but

does not dissolve in it.
■ Deliquescent – absorbs water of
hydration and dissolve in it.
■ Efflorescent – gives up water of
hydration
■ Effervescent – release of CO2
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Preparations of Powdered DF
Bulk powders, which may be used internally or
topically include:
■ dusting powders
■ douche powders

■ laxatives, antacids
■ and insufflation powders
■ After a bulk has been pulverized and blended, it
should be dispensed in an appropriate container.
■ Hygroscopic or effervescent salts- placed in a tight,
wide-mouthed jar.
■ Dusting powders -sifter top container.
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Preparation of Powdered DF

■ Eutecticmixtures of powders can

cause problems because they may
liquefy.

■ One remedy is to add an inert powder,

such as magnesium oxide, to separate
the eutectic materials.
+Molded tablets and
capsules
+
Tablets

■ Soliddosage form which may or may

not contain medicinal subtances with
or without diluents/excipients and
prepared either by molding or
compression

■ Widely used dosage form

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Tablet excipients

■ Diluents / fillers – to bring out the weight

of the tablet
■ Binders/adhesives – adhesion among the
particles on the formulary.
■ Disintegrants – promotes the breaking up
of the tablets
■ Glidants – reduces friction between the
particles
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Tablet excipients

■ Lubricant – reduces the tablets’ friction among

tablets.
■ Anti-adherants – reduce the sticking on dies.
■ Adsorbents – absorbs moisture
■ Coloring agent – for aesthetic purposes and product
identification.
■ Flavoring agents – can be oils or dry powders
■ Sweetening agents – Natural or Artificial
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Capsules
■ Capsules are solid dosage forms in which
the drug is enclosed within either a hard or
soft soluble container or shell.

■ The shells are usually made form a suitable

gelatin.
■ Hard gelatin capsules may be naturally
filled for extemporaneous compounding.
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Capsule sizes
1. A list of capsule sizes and the approximate amount of
powder that may be contained in the capsule appear
on the side of the capsule box.
2. Capsule sizes for oral administration in humans range
from no. 5, the smallest, to no. 000, the largest.
3. No. 0 is usually the largest oral size suitable for
patients.
4. Capsules for veterinarians are available in nos. 10, 11,
and 12, containing approximately 30, 15, and 1.5 g,
respectively.
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Approximate Amount of Powder
Contained in Capsules
CAPSULE SIZE RANGE OF POWDER
CAPACITY (MG)
No. 5 60-130
No. 4 95-260
No. 3 130-390
No. 2 195-520
No. 1 225-650
No. 0 325-910
No. 00 390-1300
No. 000 650-2000
 OINTMENTS,
+ CREAMS, PASTES
AND GELS
+

■ Creams are generally o/w or w/o emulsions

■ Pastes are characterized by their high
content of solids (about 25%).
■ Gels (sometimes called jellies) are
semisolid systems consisting of suspensions
made up of either small inorganic particles or
large organic molecules interpenetrated by a
liquid.
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General Characteristics

Semisolid dosage forms may

contain active drugs intended to:
1. Act solely on the surface of the skin to produce a local
effect (e.g., antifungal agent).

2. Release the medication, which, in turn, penetrates into the

skin (e.g., cortisol cream)

3. Release the medication for systemic absorption through the

skin (e.g., nitroglycerin
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MATERIALS USED FOR PACKAGING

AND STORAGE CONDITION OF
PHARMACEUTICAL PRODUCTS
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GLASS

TYPE GENERAL
USES TEST
DESCRIPTION

I Highly resistant For Parenteral Powdered

borosilicate glass glass test

II Treated soda- For Parenteral Powdered

lime glass glass test and Water
Attack

III Soda-lime For Parenteral Powdered

glass glass test

NP Non-parenteral For other Powdered

products except glass test
parenterals
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Plastics

■ Does not apply to a single material but

rather to a vast number of materials
each developed to have desired
features.

■ Two types
■ Thermoplastic
■ Thermoset
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Examples of Plastics
■ Polyethylene (PE)
■ cannot be autoclaved; low density
(droppers and sprays); high density (for
oral preps)
■ Polyethylene Terephthalate (PET)
■ for beverages; APETG (amorphous PET
glycol); PETG (PET glycol)
■ Have transparency and luster; gamma
radiation sterilization
■ Polypropylene (PP)
■ autoclavable
■ Polyvinyl chloride (PC)
■ rigid and good clarity; blister packaging
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STORAGE TEMPERATURES OF
PHARMACEUTICAL PRODUCTS
TERM CONDITION

FREEZER -25C TO -10C

REFRIGERATOR 2 - 8C

COOL 8-15C
ROOM
20-25C to 15C-30C
TEMPERATURE

CONTROLLED
20 - 25 C
TEMPERATURE

WARM 30 C to 40C

EXCESSIVE HEAT Above 40C

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End of slide

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