Pharmaceutical Dosage Form

Official Pharmacopeia
- USP 37/ NF 32

COMMINUTION TECHNIQUE
1.
2.
a.
b.

Large Scale various mills, pulverizers

Small Scale
Trituration motar and pestle
Pulverization by intervention reduce particle
size with the aid of volatile solvent
c. Levigation reduce particle size and form a
paste (mineral oil and glycerin are levigating
agents)

Bottles:
Amber Affected by the presence of light
Flint not affected by light
Wide mouth very viscous
- 2 phase system
POWDERS
- Mixture of finely divided drugs or chemicals in
drug form
- May be used internally or externally
ADVANTAGES
- Flexibility of compounding
- Good chemical stability
- Rapid dispersion of ingredients
DISADVANTAGES
- Time consuming preparations
- Inaccuracy of dose
- Unsuitably for many unpleasant tasting,
hydroscopic and deliquescent drugs

1. Sieving
2. Microscopy optical microscope to check the
particle size
3. Sedimentation rate big particles easy to fall (to
calculate: stokes law)
4. Light energy diffraction or Light scattering
5. Laser holography
6. Cascade impaction
USP STANDARDS FOR POWDERS OF ANIMAL
VEGETABLE DRUGS
Type of Powder

MICROMERITICS study of particles

MIXING mechanical process of reducing the particles
size of solids (comminution) before mixing with other
components, further process or incorporation into final
product.
ADVANTAGES
- Increase surface area, which may increase the
dissolution and bioavailability
- Increase extraction or reactivity
- Facilitates the drying of hot masses
- Improves blending and mixing
- Permits uniform distribution of coloring agents
- Improves the function of lubricants
- Improve the texture, appearance and physical
stability
DISADVANTAGE
- Can change the polymorphic form of the active
ingredients
- Degrade the drug
- Decrease bulk density
- Decrease the particle size which can cause
particle aggregation and decrease dissolution
- Increase surface area, which promotes air
absorption and inhibits wettability

Charmaine Joyce M. Matias

METHOD FOR THE DETERMINATION OF PARTICLE

SIZE

Page 1

Very coarse

Sieve size all

particles pass
through
#20

Coarse

#20

Moderately
coarse
Fine

#40

Very Fine

#80

#60

Sieve size %
particles pass
through
20% through #60
sieve
40% through #60
sieve
40% through #80
sieve
40% through
#100 sieve
No limit

USP STANDARDS FOR POWDERS OF CHEMICALS

Type of Powder
Coarse
Moderately
coarse
Fine
Very fine

Sieve size all

particles pass
through
#20
#40
#80
#120

Sieve size %
particles pass
through
60% through #40
sieve
60% through #60
sieve
No limit
No limit

Pharmaceutical Dosage Form

MIXING TECHNIQUE
1.
2.
3.
4.
5.

b. DRY GRANULATION METHOD

Spatulation
Trituration reducing and mixing
Geometric dilution equally distributed
Also used to mix potent substances
Sifting light, fluffy powder
Tumbling Large scale

1. Dry Method or Fusion

2. Shrugging compressed into a tablet and
will form small granulation
CHARACTERISTICS OF GRANULES WHICH ARE
ADVANTAGEOUS OVER POWDER

Depending on their intended use, powders are packaged

and dispensed as:
1. Bulk Powders
- Powders commonly dispensed in bulk form
- Antacid or laxative powders, douche powders,
medicated and non medicated powders for
external use, dentifrices powders for ear, nose,
throat, tooth sockets or vagina.
2. Divided Powders
- Dispensed in individual doses usually in folded
paper (latin chartulae)
- Block and divide method
- Papers that may be used:
a. Vegetable parchment semi opaque;
moisture resistance
b. White bond paper opaque; no moisture
resistant
c. Glassine paper glazed, transparent,
moisture resistant
d. Waxed paper transparent; waterproof
paper
SPECIAL PROBLEMS
1. Volatile substances
2. Liquids
3. Hygroscopic and deliquescent substances
4. Eutectic Mixtures mixing powders tend to
liquefy (have low melting points)
GRANULES
- Prepared agglomerates of small particles of
powder
- Irregularly shaped but may be spherical (ideal)
METHOD OF PREPARATION
a. WET METHOD
Powder moisture with small amount of H2O
Moistured powder
wet granules

Can be dried with oven dry or air dry and the

result will be dried granules

Charmaine Joyce M. Matias

Page 2

1.
2.
3.
4.

Flow well
More stable to atmospheric humidity
Less likely to harden upon standing
Easily wetted by liquid

EFFERVESCENT GRANULATED SALTS

- Granules or coarse to a very coarse powders
containing a medicinal agent in a dry mixture
- Composed of NaHCO3, citric acid and tartaric
acid

If H2O is added CO2 is released

If Tartaric acid is added only loose firm
If Citric acid is added only pasty

Citric acid absorbs moisture from the air

METHOD OF PREPARATION
1. Dry or Fusion method
2. Wet method
CHOCOLATE BASE Ca LOZENGES
Dietary Reference intake for calcium
AGE
mg/day
TOLERABLE
UPPER INTAKE
LEVEL (mg/day)
Infants (0-6 mos)
200
1000
Infants (6-12
260
1500
mos.)
Children (1-3
700
2500
yrs)
Children (4-8
1000
2500
yrs)
Adolescent (9-18
1300
3000
yrs)
Adult M/F (19-50
1000
2500
yrs)
Adult males (511000
2000
70 yrs)
Adult females
1200
2000
(51-70 yrs)
Adult >70 yrs
1200
2000
Pregnancy and Lactation
14- 18 yrs
1300
3000
19-50 yrs
1000
2500

Pharmaceutical Dosage Form

Lozenges used for local effect
1. Topical anesthetic
2. Demulscents
3. Patients with difficulty in swallowing
4. Anti-fungal agent

2. Soft gel capsule elastic; glycerin or

polyhydrate alcohol (sorbitol) to make soft gel
capsule elastic; prone to have contamination;
add preservative
- Water, colorant, glycerin, preservative,
opacifying agent; easily decomposed

METHOD OF PREPARATION
Sulfur dioxide (0.15%) prevents or avoids
decomposition during manufacturing of soft gel
capsules.

1. Hand Rolled
Advantage:
- Do not require special calculations
- Special equipment is not required
Disadvantage:
- Preparing and forming requires experience and
good techniques

GELATIN from the skin of pig

- Partial hydrolysis of collagen that is usually
found in the skin
TYPE A acid treated gelatin
TYPE B - base treated gelatin
Several sized hard gel capsule # - depends on volume

2. Fusion or molding
000

Advantage:
- Better tasting lozenges
- Elegant appearance
Disadvantage:
- Special molds are required
- Special skills, experience and care required
- Not applicable for heat sensitive substance
3 TYPES OF LOZENGES:
-

1. Hard Lozenges
Made from syrups of sucrose and other sugars
or carbohydrates that are boiled
Moisture content is 0.5% to 1.5%
Preparing is similar to candy making
2. Soft Lozenges
Made from flavored fatty base such as
chocolate, polyethylene glycol (PEG) base and
sugar acacia base

7.5 gr

5 gr

4 gr

3 gr

2 gr

1 gr
(smallest)

Moisture content of hard gel capsule H2O 12-16%

Filling of capsule
1. Punch punch, rotate, punch, rotate
- Polish with clean towel moisten with small
amount of mineral oil
Do not hold the capsule just roll
Put in a bottle with dessicant (cotton)
2. Filling Machines

3. Chewable gummy gel lozenges

Glycerinated gelatin base

METHOD OF PREPARATION OF SOFT GELTATIN

CAPSULE

ASPIRIN CAPSULES
Capsules solid dosage form in which active ingredients
are enclosed in a gelatin capsule
Gelatin capsule made up of gelatin, water, (colorant),
opacifying agent (TiO2)
2 TYPES OF CAPSULES
1. Hard gel capsule / dry filled capsule (OFC)
- Made up of gelatin, sugar and water
Charmaine Joyce M. Matias

00

15 gr
(largest)
10 gr

Page 3

1. Plate Process
2. Rotary or Reciprocating Process
3. Accogel Capsule Machine

When very humid the capsule will absorb excess

moisture and will be deformed
When it is too hot the moisture will evaporate
and the capsule will be very brittle that is why
there is a need for a dessicant.