CA P S UL E S

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 The definition of capsules

Capsules are solid dosage forms in which

medicinal agents and/or inert substances are
enclosed within a small shell of gelatin. Gelatin
capsule shells may be hard or soft depending on
their composition.

capsules so much that today about 20% of dosage

forms (popular like tablets)

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 Administration route of capsules

1. Orally .
2. Modern uses of gelatin capsules
1. Rectum (instead of suppositories)
2. Vagina (instead of suppositories)
3. Hard gelatin capsules have also been used for drug delivery in
bronchial tract. The drug in the micronized from in a capsule.(To
release the drug the capsule is punctured thereby releasing a fine
powder mist which is inhaled into the lungs along with the

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 Advantages of capsules for oral
administration
1. Conveniently carried
2. Readily identified
3. Easily taken
4. Prescribing flexibility
6. Packaged and shipped at lower cost and with less breakage
7. More stable and have a longer shelf-life
8. Empty hard gelatin capsules are often used in the
extemporaneous compounding of prescriptions.

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 Disadvantages
1) More expensive.
2)Prone to the effect of humidity &microbial
contamination.
3) Difficult for some peoples to swallow.

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 Capsules formulation

1) Active ingredient(drug).
2) Non-active ingredients:-
2-a)diluents &fillers.
2-b)lubricants& glidants.

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 Diluents
1) Organic diluents 2) Inorganic diluents
- Lactose.  Calcium sulphate.

- Starch.  Dicalcium phosphate.

- Microcrystalline cellulose??  Magnesium carbonate.

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 Diluents
Water soluble diluents are not
recommended for both hydrophilic &
hydrophobic drugs?
Competition with the drug for dissolution
in G.I.T—retard the dissolution of
drugs.

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 Lubricants & Glidants
 Essential ---------- Flowability.
 When certain diluents having low flowability such
as lactose----addition of lubricants &/or glidants
will be essential.

 E.g. (lubricants): Magnesium stearate &

Magnesium stearyl fumarate.
 E.g. (glidants) : Silicon dioxide

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 Types of capsules

Gelatin capsule shells may be hard or soft depending on

their composition.

 Hard gelatin capsules

 Soft gelatin capsules

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 Hard Gelatin Capsules
 Composed of gelatin, plasticizers and water.
 Contain 10 - 15 % moisture
 Typically filled with dry solids
 Powders
 Granules
 Pellets
 Tablets
 Now days it used to enclose
» Oils
» Pastes
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 Hard Gelatin Capsules
 Advantages
 Tasteless and odorless
 Swallowing is easy
 Flexibility in formulating
 Uniquely suitable for blinded clinical trials
 Useful for extemporaneous compounding by pharmacist
 Disadvantages
 Tend to be more expensive to produce than tablets
 Not suitable for highly soluble salts

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 Hard Gelatin Capsules sizes
 The shells for human use are marketed in 8 size
depends upon its density and compressibility.
Normally the shell manufacturers give a guidance of
the approximate quantities of selected drugs that can
be contained in different sizes.
SIZE VOLUME (cm3)
000 1.37
00 0.95
0 0.68
1 0.50
2 0.37
3 0.30
4 0.21
5 0.13
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 Preparation of filled hard gelatin
capsules
 The general steps of preparation
1. Developing and preparing the formulation and
selecting the size of capsule.
2. Filling the capsule shells.
3. Capsule sealing (optional).
4. Cleansing and polishing the filled capsules.

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 Developing the formulation and
selection of capsule size

The pharmaceutical processing in the preparation

of filled hard gelatin capsules
1. Blending: → uniform powder mix, uniform drug
distribution
2. Comminution/milling: 50~100 microns, suitable
for a drug of low dose (10mg or greater)

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 Developing the formulation and
selection of capsule size
The pharmaceutical excipient in the preparation of filled
hard gelatin capsules
1) Diluents/filler: to produce the proper capsule fill volume; to
provide cohesion to the powders,
e.G. Lactose, microcrystalline cellulose and starch
2) Disintegrants/disintegration agents: to assist the break-up and
distribution of the capsule contents
e.g. pregelatinized starch, croscarmellose and sodium starch
glycolate

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 Developing the formulation and
selection of capsule size
The pharmaceutical excipient in the preparation of filled
hard gelatin capsules (continued)
3) Lubricant or glidant: to enhance the flow properties of the
powder mix
e.g. fumed silicon dioxide, magnesium stearate, calcium stearate,
stearic acid, or talc
#: magnesium stearate, water-proofing characteristics, retard
penetration of the GI fluids, delay drug dissolution and absorption
4) Wetting agents: to facilitate wetting of the dry powder
e.g. surfactants, as sodium lauryl sulfate

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 Other additives
 Plasticizers used are glycerine, sorbitol etc.
 Preservatives, if included, are generally a mixture
of methylparaben (4 part) and propylparaben (1
part ) to the extent of 0.2%.
 Flavours, if added, should not exceed 2% and are
generally ethylvanillin or essential oils.
 Sugar, if included, may be up to 5% to give the
gelatin shell desirable chewable characteristics.

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 Developing the formulation and
selection of capsule size
Examples of filled hard gelatin capsules
1) Tetracycline capsules
Active ingredient: Tetracycline hydrochloride, 250 mg
Filler: Lactose
Lubricant/glidant: Magnesium stearate
Capsule colorants: omitted
Capsule opaquant: Titanium dioxide

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 Filling hard capsule shells

1. The “punch” method

suitable for filling a small number of capsules in the
pharmacy
1. Placing the powder on paper
2. Forming the powder mix into a cake
3. punching the empty capsule body into the powder
cake
4. Nonpotent drugs: the first filled capsules should be
weighed. The other capsules should be weighed
periodically.
5. Potent drugs: each capsules should be weighed .

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 Filling hard capsule shells

2. The pouring method

1. Suitable for filling a small number of capsules
in the pharmacy
2. Suitable for granular material

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 Filling hard capsule shells

3. Hand-operated capsule filling machines

consist of a couple of plates

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 Filling hard capsule shells

4. Machines for industrial use

The process of working:
1.Separating the caps from empty
capsules
2.Filling the bodies
3.Scraping the excess powder
4.Replacing the caps
5.Sealing the capsules
6.Cleaning the outside of the filled
capsules

165,000 capsules per hour

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 Soft Gelatin Capsules (Softgels)
 The composition of soft gelatin capsule shells is
similar to the hard gelatin capsules except that a larger
proportion of plasticizer is incorporated to make them
soft and elastic ) glycerine or polyhydric alcohol (ex.
Sorbitol)(
 Formed, filled, and sealed in one operation
 Shells are softened by addition of glycerin or
polyhydric alcohol (ex. Sorbitol)
 Oblong, spherical, elliptical in shape

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 Soft Gelatin Capsules (Softgels)

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 Soft Capsules
 ADVANTAGES
 May contain liquids, suspensions, pastes
 Rapid release of contents
 Useful for drugs prone to oxidation

 DISADVANTAGES
 Have a greater tendency to adhere to each other
 More expensive
 Increased possibility of interactions between drug and shell

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 Soft gelatin capsules
The pharmaceutical applications of soft gelatin capsules
are
1. As an oral dosage form
2. As a suppository dosage form
3. As a specialty package in tube form, for human and
veterinary single dose application of topical,
ophthalmic, and otic preparations, and rectal
ointments.

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 The fill material of soft gelatin capsules

 The liquids that are packaged are generally of the

following kinds:
1. Vegetable or aromatic oils, hydrocarbons, ethers, esters,
alcholos and organic acids which are water immiscible;
2. Polyethylene glycols and non-ionic surfactants which are
water miscible;
3. Water miscible and relatively non-volatile compounds such as
glycerin, propylene glycol (up to 5-10% of total liquid),
isopropyl glycol etc.
 The liquid combinations for encapsulation in soft gelatin
capsules must be able to flow by gravity at about 35 0C or
less (optimum viscosity)
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 Soft gelatin capsules
 Liquids which cannot be capsulated thus are:
1. Water (more than 5%), alcohols, ketones, acids, amines,
esters etc. which can leak through the capsule shell.
2. Liquids with pH below 2.5 or above 7.5 should also be
avoided since acidic liquids cause hydrolysis of the shell and
alkaline ones cause tanning affecting solubility characteristics
of the shells.

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 Soft gelatin capsules
 A suspending agent is generally incorporated in all such mixes
intended for encapsulation in soft gelatin capsules to maintain
homogeneity prior to, during and after encapsulation.
 For hydrophobic bases waxes (5 to 10% of base) may be used

 for hydrophilic ones PEG 4000 and PEG 6000 (1 to 15% of

base) are considered suitable.

 Sometimes incorporation of wetting agents also becomes
necessary when the solids are not properly wetted by the base.
 Soy lecithin (2-3% of the weight of base) is very good as

wetting agent

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 Preparation of soft gelatin capsules
1. The plate process (using a set of molds)
The plates contain die pockets.
1) placing a warm sheet of gelatin on the bottom plate
2) pouring the liquid-containing medications
3) placing the second sheet of gelatin
4) putting the top plate of the mold into place
5) pressing the mold to form, fill, and seal the capsules
simultaneously
6) removing and washing the capsule
Today, this equipment can no longer be purchased.

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 Preparation of soft gelatin capsules
2. The rotary die process
more efficient and productive
1) Liquid gelatin is formed into two ribbons
2) The two ribbons are brought together
3) Metered fill material is injected between the ribbons
4) These pockets of fill-containing gelatin are sealed

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 Rotary die soft capsule
machine The dies for production of soft
capsule

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