This document provides information on capsules, including definitions, advantages, disadvantages, types (hard gelatin and soft gelatin capsules), and manufacturing processes. It defines capsules as solid preparations with shells containing a single dose of active ingredients. Hard gelatin capsules are made of gelatin and can contain powders, granules, or pellets, while soft gelatin capsules contain liquids, suspensions, or semisolids. The manufacturing of both types involves processes like dipping, drying, trimming, and filling. Specifications for gelatin and requirements for capsules in compendia are also outlined.

2. CAPSULES
• DEFINITION:
According to B.P.
“Capsules are solid preparations with hard
and soft shells of various shapes and
capacities, usually containing a single dose of
active ingredients.”

3. ADVANTAGES
• Capsules are tasteless, odorless and can easily be
administered.
• 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.
• Physician can change the dose and combination of
drug according to patient requirement.
• They are economical.
• They are easy to handle and carry.

4. DISADVANTAGESDISADVANTAGES::
• Hygroscopic drugs are not suitable for filling
into capsules, because they absorb water
present in capsule shell makes shell very
brittle and ultimately lead to crumble into
pieces.
• The concentrated solutions which require
previous dilution are unsuitable for capsules
because if administered as such lead to
irritation into stomach

5. TYPES
• Hard gelatin capsules
• Soft gelatin capsules

6. HARD GELATIN CAPSULE
• DEFINITION:-
These are solid dosage form of medicaments,
in which drug is enclosed within the shells
made up of gelatin.
These capsules are made up of gelatin blends,
small amount of certified dyes, opaquants,
plasticizers and preservatives.

7. Certified Dyes
Colour approved by D & C act.
Opacifiers
Tio2
Plasticizers
Sorbitol, Glycerin.
Preservatives
Propyl and Methyl Parabens

8. GELATIN
• Gelatin is heterogeneous product derived by
hydrolytic extraction of animal's collagen.
• The sources of gelatins including animal
bones, hide portions and frozen pork skin.
TYPES OF GELATIN
Type A
Type B

9. TYPE A
Derived from acid treated precursor that
exhibits an iso electric point at pH-9. It is
manufactured mainly from pork skin.
TYPE B
Derived from alkali treated precursor that
exhibits an iso electric point at pH-4.7. It is
manufactured mainly from animal bones

10. PARTS OF CAPSULE
CAP
BODY

11. MANUFACTURE OF EMPTY
GELATIN CAPSULES
Steps involved in making empty gelatin
Capsules:-
• Dipping
• Spinning
• Drying
• Stripping
• Trimming and Joining
• Polishing

13. 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 500
C in a heated, jacketed
dipping pan.

14. 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.

15. 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

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.

17. SIZE OF CAPSULES

18. SIZE OF CAPSULES
The largest size of the capsule is No: 000.
*The smallest size is No: 5.
*The standard shape of capsules is traditional, symmetrical
bullet shape.

19. FILLING OF HARD CAPSULES
Various Filling Machine Available…
• Eli-lily and Co
• Farmatic
• Hofliger and Karg
• Zanasi
• Parke-Davis.
• These machine differ in there design and output

20. POLISHING AND STORAGE
Pan Polishing : Acela-cota pan is used to dust and
polish.
Cloth Dusting : Capsule are rubbed with cloth.
Brushing : Capsule are feed under soft rotating
brush.
STORAGE
• Finished capsules normally contain an
equilibrium moisture content of 13-16%.
• To maintain a relative humidity of 40-60% when
handling and storing capsules

21. SOFT GELATIN CAPSULE
Definition:-
•Soft Gelatin capsules are
one piece, hermetically
sealed, soft gelatin shells
containing a liquid, a
suspension, or a semisolid.
•Soft gelatin is mainly
composed of gelatin,
plasticizers, preservative,
colouring and opacifying
agents, flavoring agents
and sugars.

22. APPLICATIONS
The pharmaceutical applications of soft gelatin
capsules are:
as an oral dosage form
as a suppository dosage form
as a specialty package in tube form, for
human and veterinary use, single dose
application for topical, ophthalmic, and rectal
ointments.

23. PLASTICIZER AND GELATIN
RATIO
• In soft gelatin capsule the amount of
plasticizers used is more
• In soft gelatin capsule the plasticizer and
gelatin ratio is
0.8 : 1
• In hard gelatin capsule the plasticizer and
gelatin ratio is
0.4 : 1

24. MANUFACTURING
Is manufactured by THREE methods
• Plate process
• Rotary die process/Reciprocating die
• Globex method

25. PLATE PROCESS
 A warm sheet of plain or colored gelatin is placed on
the bottom plate of the mold and the liquid-
containing medication is evenly poured on it.
 A second sheet of gelatin is carefully placed on top of
the medication and the top plate of the mold is put
into place.
 Pressure is then applied to the mold to form, fill, and
seal the capsules simultaneously.
 The capsules are removed and washed with a solvent
harmless to the capsules

26. ROTARY
DIE/RECIPROCATING
Liquid gelatin flowing from an overhead tank is
formed into two continuous ribbons by the
rotary die machine and brought together between
twin rotating dies.
At the same time, metered fill material is injected
between the ribbons precisely at the moment that
the dies form pockets of the gelatin ribbons.
These pockets of fill-containing gelatin are sealed
by pressure and heat and then severed from the
ribbon.

27. GLOBEX METHOD
Filling is pumped through the inner
capillary of a concentric double
capillary
• Shell forming solution is pumped
through the outer capillary of the
concentric double capillary
• The soft capsules are then immersed
in a cooling bath of about 4o
c (usually
liquid paraffin).
• Cooling bath ensures immediate sol-
gel transformation, hence formation
of flexible yet firm robust outer film.
• Soft capsules are collected, washed
with organic solvent to remove
residues of cooling liquid, and gently
dried at a relative humidity of 20% in
infrared tunnels

29. Use of soft Gelatin Capsules
POWDERS- CAPSEAL GRANULES

30. BEADS
TABLETS

31. PASTES
LIQUIDS - CAPSEAL

32. IMPORTANT
SPECIFICATIONS OF
GELATINBloom or gel strength: It is a measure of cohesive
strength of cross-linkage that occurs between
molecules and is proportion to the molecular
weight of gelatin.
Bloom is determined by measuring the weight in
grams required to move a plastic plunger of
0.5inches in diameter, 4mm into a 62/3% gelatin
that has held at 10°C for 17 hrs.
The unit of bloom is grams and it is between 150-
250g

33. Viscosity: Is determined on a 62/3% gelatin of
water at 60°C and it is a measure of the
molecular chain length.
Standard used: 25-45 mill poise.
Iron content: Iron is always present in raw
gelatin, and its concentration usually depends
on the iron content of the large quantities of
water used in its manufacture .
amount should not exceed 15ppm.

34. Compendial Requirements for
Capsules
• 1. Added Substances
a. Harmless in the quantities used
b. Do not exceed the minimum amounts required
to provide their intended effect
c. Do not impair the product’s bioavailability,
therapeutic efficacy or safety
d. Do not interfere with requisite compendial
assays and test

35. 2. Containers for dispensing
• Tight, well closed and light resistant containers
depending on the item
3. Disintegration Test for Capsules
• The capsules are placed in the basket rack
assembly, which is immersed 30 times per
minutes into a thermostatically controlled fluid at
37 0
C and observed over the time described in the
individual monograph

36. 4. Dissolution Test for capsules
5. Weight Variation
@ Hard Capsules - 10 capsules are individually weighed and
the content removed. Empty shells are individually weighed
and the net weight of the contents calculated by subtraction
@ Soft Gelatin - the gross weight of 10 intact capsules is
determined individually. Then each capsules is cut open and
the contents removed by washing with suitable solvent. The
solvent is allowed to evaporate at room temperature over
about 30 minutes. The individual shells are weighed and net
contents calculated

37. REFERENCES