This document discusses capsules as a pharmaceutical dosage form. It defines capsules as solid dosage forms where the drug is enclosed in a soluble shell, usually made of gelatin. There are two main types of capsules: hard gelatin capsules which contain powders, and soft gelatin capsules which contain liquids. The document describes the components, manufacturing process, filling, and evaluation of both hard and soft gelatin capsules. It also discusses the advantages and disadvantages of capsules as a dosage form.

1. Presented by – Vedant Kumar Gupta
M. Pharma (Pharmaceutics)
2nd Semester (2019-2020)
CSJM UNIVERSITY KANPUR
(UNIVERSITY INSTITUTE OF PHARMACY)
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2. CONTENT
 DEFINITION
 ADVANTAGES
 DISADVANTAGES
 GELATIN
 HARD GELATIN CAPSULE
 SOFT GELATIN CAPSULES
 COMPONENTS OF CAPSULES
 MANUFACTURE OF EMPTY GELATIN CAPSULES
 FILLING OF HARD GELATIN CAPSULES
 FILLING OF SOFT GELATIN CAPSULES
 EVALUATION OF CAPSULES
 PACKING AND STORAGES OF CAPSULES
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3. Definition
 Capsules are a unit solid dosage form in which
the drug substance is enclosed in a water
soluble shell or an envelope. A capsule shell is
made from gelatin. The capsules are divided in
to two part cap and body
Capsules are of two types
1. Hard gelatin capsules
2. Soft gelatin capsules
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5. Advantages
 Capsules are tasteless, odorless and can easily
be administered.
 Combination of powders we can use
 There are attractive in appearance.
 The drugs having un-pleasant odor and taste are
enclosed in a tasteless shell.
 They can be filled quickly and conveniently.
 They are economical.
 They are easy to handle and carry.
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6. Disadvantages
 The hygroscopic drugs can not be filled in
capsules. They absorb water present in the
capsule shell and hence make it very brittle,
which ultimately breaks into pieces.
 The concentrated preparations which need
previous dilution are unsuitable for capsules
because it may lead to irritation in stomach
if administered as such.
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7. Capsules size
 For human use, empty capsules ranging in size from 000
the largest to 5 the smallest. Generally, hard gelatin
capsule are used to encapsulate between 65 mg to 1
gram.
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8. Gelatin
 Gelatin or gelatine (from Latin: gelatus meaning
"stiff", "frozen") is a translucent, colourless, brittle
(when dry), flavourless foodstuff, derived from collagen
obtained from various animal by-products.
 It is commonly used as a gelling agent in food,
pharmaceuticals, photography, and cosmetic
manufacturing.
 Gelatin is an irreversibly hydrolyzed form of collagen
 Gelatin is heterogeneous product derived by hydrolytic
extraction of animal's collagen.
 The sources of gelatins including animal bones, and
frozen pork skin.
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9. Types of gelatin
 TYPE A
Derived from acid treated precursor that exhibits an
isoelectric point at pH-9. It is manufactured mainly from
pork skin.
 TYPE B
Derived from alkali treated precursor that exhibits an
isoelectric point at pH-4.7. It is manufactured mainly
from animal bones
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10. Preparation of gelatin
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11. 1. Hard gelatin capsules
 These are used for administration of solid medicaments.
 The capsule shell is prepared from gelatin, color and
titanium dioxide to make it opaque.
 It consists of two parts i.e. body and cap.
 The powdered material is filled into the cylindrical body
of the capsule and then the cap is placed over it.
 The empty capsules are available in various sizes.
 They are numbered according to the capacity of the
capsules.
 The number starts from 000 and goes up to 5.
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12. 2. Soft gelatin capsules
 These are used for administration of liquid
medicaments.
 Soft gelatin capsules are available in round, oval
and tube like shapes.
 They are made from gelatin.
 The gelatin is plasticized by the addition of
glycerin and sorbitol etc.
 The soft gelatin shell may contain a preservative
to prevent the growth of fungi.
 They are used to enclose liquid medicaments-oils,
suspensions, food concentrates and ophthalmic
products.
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13. Components of capsules
1. Gelatin
2. FD & C and D & C colorant
3. Sugar
4. Water - 12 to 16 % (may vary depending on the storage
condition )
5. Sulfur dioxide (15%) - prevent decomposition during
manufacture
6. Colorants / Opacifying agent : There are two types
A) water soluble dyes – e.g. erythrosine
B) pigments – e.g. iron oxides , titanium dioxide
(make the capsule opaque to provide protection
against light)
7. Preservatives: To prevent microbial growth
during manufacture
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14. Manufacture of empty gelatin
capsules
 Steps involved in making empty gelatin
capsules…
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming and Joining
6.Polishing
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15.  Dipping :
Pairs of the stainless steel pins are dipped into the dipping solution to
simultaneously form the caps and bodies.
The dipping solution is maintained at a temperature of about 500C in a
heated, jacketed dipping pan.
 Spinning :
The pins are rotated to distribute the gelatin over the pins
uniformly and to avoid the formation of a bead at the capsule ends.
 Drying :
The gelatin is dried by a blast of cool air to form a hard shells.
The pins are moved through a series of air drying kilns to remove water
 Stripping :
A series of bronze jaws strip the cap and body portions of the capsules
from the pins.
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16.  Trimming and joining
The stripped cap and body portions are trimmed to the
required length by stationary knives.
After trimming to the right length, the cap and body
portion are joined and ejected from the machine.
 Polishing
1. Pan Polishing : Acela-cota pan is used to dust and
polish.
2. Cloth Dusting : Capsule are rubbed with cloth.
3. Brushing : Capsule are feed under soft rotating brush.
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17. Filling of hard gelatin
capsules
 The capsules can be filled either by hand or by a
semiautomatic device or by an automatic filling machine.
 Capsule filling machine (Hand operated) It consists
of:-
1. A bed having 200-300 holes
2. A loading tray having 200-300 holes
3. A powder tray
4. A pin plate having 200-300 pins
5. A sealing plate having a rubber top
6. A lever
7. A cam handle
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18. Hand operated capsules filling machine
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19. Filling of soft gelatin capsules
 Soft gelatin capsules are generally filled mechanically.
 The manufacturing of the capsule shell and the filling of
the medicament take place simultaneously.
 Nowadays, a rotary machine is used for this purpose.
 In a rotary die machine, the soft gelatin capsules are
prepared and then filled immediately with the liquid
medicaments.
 The machine consists of two hoppers.
 Liquid gelatin mixture is placed in one hopper and the
liquid medicament in the other hopper.
 There are two rotating dies which rotate in opposite
directions.
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20. Rotary dia process
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21. Plate process
 Place the gelatin sheet over a die plate
containing numerous die pockets.
 Application of vacuum to draw the sheet in to the
die pockets.
 Fill the pockets with liquid or paste.
 Place another gelatin sheet over the filled
pockets.
 Sandwich under die press where the capsules
are formed and cut out
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22. Evaluation of capsules
 Disintegration test
 Dissolution test
 Content uniformity
 Weight variation
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23. Packing and storages of
capsules
 Capsules should be packed in well-closed glass or
plastic containers and stored at a temperature not
exceeding 30ºC.
 Capsules can be individually protected by enclosing
them in a strip or blister packs
 In strip packing, the capsule is hermetically sealed within
the strips of an aluminum foil and/or plastic film.
 The contents are removed from the strip packs by
tearing or cutting to separate the capsules.
 In case of blister packs, a press on the blister forces the
capsule through the backing strip.
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