This document discusses capsules, including definitions of hard and soft gelatin capsules. Hard gelatin capsules have two sections and are used to store dry materials, while soft gelatin capsules contain glycerin or sorbitol and store semi-solid preparations. The document outlines the manufacturing process for both types of capsules and describes quality control tests like disintegration testing, weight variation testing, and dissolution testing to ensure capsule quality and stability.

2.  DEFINITION
 TYPES OF CAPSULES
 SIZE & SHAPE OF CAPSULE
 MANUFACTURING OF HARD GELATIN
CAPSULES
 MANUFACTURING OF SOFT GELATIN
CAPSULES
 BLOOM STRENGTH OF GELATIN
 BASE ABSORPTION FACTOR
 Q.C OF CAPSULES AND STORAGE
 FILLING OF CAPSULES

3.  Capsules are solid dosage forms in which the drug
substance is enclosed within either a hard or soft
soluble shell, usually formed from Gelatin.

4. • Hard gelatin capsules Soft gelatin capsules

5.  Hard gelatin capsules shells are hard and consists of
two sections used for filling dry materials in body
capsules.
 These are plasticized gelatin capsules vastly used
nowadays.
 Solid form of drugs are stored.
 Dissolves slower than soft gelatin capsules.
 Drug formulations:
Powders
Granules

6. • Particle size
• Polymorphism
• Influence of diluents & excipients

7.  Soft gelatin capsules are made of gelatin to which
glycerine or a polyhydric alcohol such as sorbitol has
been added to render the gelatin elastic or plastic like.
 These are non-plasticized gelatin capsules.
 Hydrophobic drugs are stored.
 Semi solid preparations are stored.

8. • High water content
• Crystallisation
• Alter in drug dissolution character
• High moisture content

9. Stainless steel mould pins
Dipped into warm gelatin solution
Shells are formed by gelatin on the pin surfaces
Gelatin produced by hydrolysis of animal collagen from
connective tissue, bone, skin

10. Two basic types
Type A Type B
Produced by acid Produced by alkaline
hydrolysis mainly hydrolysis mainly from
from pork skin. Animal bones.

11. Both are differentiated by iso electric points, viscosity and
film forming characters
Some cases pork skin and animal bones are combined in
optimizing the capsules.
Pork skin provides clarity and plasticity
Animal skin provides firmness
Iron oxides are used as pigments

12. Titanium di oxides are used to render the shell opaque to
protect from light
Parabens are used as preservative
Capsule fill weight = tapped bulk density x capsule
volume

13. Soft gels

16.  Bloom is a test measure the strength of gelatin. The
test was originally developed and patented by
O.T.Bloom.
 The test determines the weight (in gms) necessary to
depress the surface of the gel 4mm with a standard
plunger. The result is expressed in Bloom, it is usually
between 30 - 300.
Strength of gel,
Low – 120g
Medium – 120 – 200g
High - >200g

17.  This test is generally performed for soft gels, a 6.67%
gelatin solution is kept for 17 – 18 hrs at 10°C .
 Gel strength increases with concentration and decreases
with temperature.

18. Base adsorption factor = weight of the base
weight of the solid
Minim per gram factor
The minim per gram factor is the volume in minims
that is occupied by one gram (S) of the solid plus the weight
of the liquid base (BA) required to make a capsulatable
mixture.
(BA+S) x V/W = M/g
V = minims
W = weight

19.  PHYSICAL TEST:
◦ Disintegration test
◦ Weight variation test
◦ CHEMICAL TEST:
◦ Dissolution
◦ Assay
◦ Content uniformity
◦ Stability testing
◦ Moisture permeation test

20.  DISINTEGRATION TEST
This test helps to determine whether the capsules disintegrate
within the prescribed time when placed in a liquid medium
under the prescribed experimental conditions.
• WEIGHT VARIATIONS TEST:
This demonstrates the uniformity of dosage units
• CHEMICAL TEST
DISSOLUTION TEST:
It determines the amount of drug substance that goes into
the solution per unit time under standard conditions of liquid /
solid interphase, temperature and solvent composition.

21.  CONTENT UNIFORMITY:
◦ It shows the distribution of active contents within the
production batch.
STABILITY TESTING:
• To determine the intrinsic stability of the active drug molecule
and the influence of environmental factors such as
temperature, humidity, light, formulative components and the
container and closure system.

22.  MOISTURE PERMEATION TEST:
◦ To determine the degree and rate of moisture penetration by
packaging the dosage unit together with a color revealing
dessicant pellet and exposing the packaged unit to known
relative humidity over a specified time. Then observing the
described pellet for color change and comparing the pre-test
and post-test weight of the packaged unit.

23.  Capsules attain a equilibrium moisture content of 13-16%. It is
critical to physical properties of shell.
 Low moisture content (<12%) – too brittle
 High moisture content (>18%) – too soft.
 Relative humidity of 40-060% is maintained.
 Bulk moisture in capsules shells is physically bound and it
readily transfer to other shells, which cause splitting/cracking
in deliquescent drugs.
eg: potassium acetate & sodium cromate
Transfer of moisture to drugs cause cocking and retard
disintegration and stability problems.