Soft Gelatin Capsules .ppt

Soft Gelatin Capsules .ppt

1. Topic- Soft Gelatin CapsulesTopic- Soft Gelatin Capsules
Presented by Presented by
Hariom JaiswalHariom Jaiswal
Asst. Pro. B.PH 3Asst. Pro. B.PH 3
rdrd
Year Year
Industrial PharmacyIndustrial Pharmacy
Rajiv Gandhi College of Pharmacy Nautanwa Rajiv Gandhi College of Pharmacy Nautanwa
Maharajganj Maharajganj
UP 273164UP 273164

2. ContentsContents
 Introduction.
 Advantages.
 Disadvantages.
 Shapes Of Capsules.
 The Nature Of Capsule Shell.
 The Nature Of Capsule Content.

3.  Manufacturing / Production Process Of Soft
Gelatin Capsule.
 In Process Testing.
 Finished Product Testing.
 Application of SGC

4. Soft gelatin capsuleSoft gelatin capsule
Definition:-
Soft gelatin capsules are one
piece, hermetically sealed, soft
gelatin shells containing a liquid,
a suspension, or a semisolid.
The nomenclature for this
dosage form has now been
changed to soft gel
 They have long been preferred
dosage form for those, taking
health & nutritional supplements.

5. ADVANTEGESADVANTEGES
Easy to administer
Easy to Manufacture
Liquids can be encapsulated ( non water soluble)
Small to large sizes possible
Elegance
Portability
Odour and taste masking
Ready availability of drug hence faster action.
Specialised dosage forms can be made e.g. chewable,
extended release, captabs etc.
Can be used for ophthalmic preparations e.g. aplicaps,
vaginal / rectal suppositories

6. DISADVANTEGESDISADVANTEGES
Water soluble material are difficult to
incorporate
Highly Moisture sensitive

Efflorescent material cannot be incorporated,
they may cause softening / leaching
Deliquescent materials cannot be
incorporated, they may cause hardening or
brittle capsules. .

7. SHAPES OF CAPSULES SHAPES OF CAPSULES

10. NATURE OF CAPSULE SHELLNATURE OF CAPSULE SHELL
 The capsule shell is basically composed of Gelatin,
a plasticizer & water, it may contain additional
ingredients such as preservative ,coloring &opacifying
agents, flavorings, sugars, acids & medicaments to
achieve desired effects.
 GELATIN:- Obtain from partial hydrolysis of
collagen derived from the skin, connective tissue &
Bones of animals. may have viscosity of 38 mpa
Bloom strength:-150-250
cost of gelatin α Bloom strength

11. WATER:- n.m.t. 45% w/w
•The ratio by weight of water to dry gelatin can
vary from 0.7 to1.3(water) to 1.0(dry gelatin)
depending on the viscosity of the gelatin being
used.
PLASTICIZER:-Used to make the soft gel
shell elastic & pliable.
• Ratio used is between 0.3 to 1.8 for soft to hard
shell on dry basis.
•E.g. glycerin , sorbitol

12. Preservatives :- added in concentration of
0.2%. Eg. methyl paraben and propyl
paraben.
Opacifying agent :- titanium oxide used in
0.2 – 1.2%
Flavouring agent :- used in concentration of
0.1-2%. Eg. ethyl vanillin.

13. CAPSULE CONTENTCAPSULE CONTENT
Content may be liquid, or a combination of
miscible liquids,
A solution of a solid(s) in a liquid(s) or a
suspension of a solid(s) in a liquid(s).
It can be a liquid like a volatile oil
composition. e.g.Pudin hara.
Vegetable oils like arachis oil or aromatic or
aliphatic hydrocarbons, ethers, esters, or
alcohols.

14. Solids that are not Sufficiently
soluble in liquids or in combination
of liquids are capsulated as
Suspension.
Suspending agents used are
Lecithin, Soyabean oil, yellow wax.

15. BASE ADSORPTION FACTOR (BA)BASE ADSORPTION FACTOR (BA)
Base adsorption is defined as the number of
grams of liquid base required to produce the
capsulated mixture when mixed with 1 gm of
solid(s). BA of a solid is influenced by its particle
size and shape, its physical state ( fibrous,
amorphous or crystalline), its density, its moisture
content, and its oleophilic or hyrophilic nature.
In determination of a BA factor, the solid must be
wetted thoroughly by the liquid base, and in case of
solids that are not easily done, a wetting agent is
required.

16. Procedure :-
Two 150 ml beakers are taken. Weigh a definite amount of solid
(40gm) into one beaker, and 100g of the liquid base in the other.
Add small increments of the liquid base to the solid, and using a
spatula, stir the base into the solid, until the solid is thoroughly
wetted and uniformly coated with the base. This produces a
mixture that has a soft ointment like consistency.
Continue to add liquid and stir until the mixture flows steadily
from the spatula when held at a 45 angle. As the mixture tends to
⁰
stop flowing, note down the weight of the added liquid base.
Formula of finding BA Factor :-
BA = weight of the liquid base added / weight of the solid
Lower the BA of the solid, higher the density of the mixture,
smaller the capsule size.

17. MINIM / GRAM FACTOR (M/G)MINIM / GRAM FACTOR (M/G)
BA factor is used to determine the minim/ gram factor of the
solid.
M/G factor is the volume in minims that is occupied by
one gram of solid plus the weight of the liquid base required
to make the capsulated mixture.
M/G factor is calculated by the following formula,
M/G = {( BA + S ) x V } / W
S = gram of solid
W = weight of the mixture
V = minim

18. Problem :-
A soft gelatin capsule (4gm mixture ) of drug (1gm) by
using vegetable oil (liquid base) is to be prepared. If BA =
0.75 gm and M/G = 25, then find the volume to be
capsulated.
Solution :-
M/G = {( BA + S ) x V } / W
25 = {( 0.75 + 1 ) x V } / 4
V = 3.52 ml or 57.14 minims
( 1 minim = 0.062 ml)

19. MANUFACTURE/ MANUFACTURE/
PRODUCTION PROCESS: PRODUCTION PROCESS:
 Originally, soft gelatin capsules are made using
leather mold and later iron mold for shaping the
capsules. As technology advanced, the individual iron
molds gave way to multiple molding units, and theses
led to sets of plates containing pockets.
1. Plate process
2.Rotary die press
3.Accogel process
4.Bubble method

20. 1. PLATE PROCESS1. PLATE PROCESS
•The process involved-:
Placing the upper half of a plasticized gelatin sheet over a die
plate containing numerous die pockets,
Application of vacuum to draw the sheet in to the die pockets,
Filling the pockets with liquor or paste,
Folding the lower half of gelatin sheet back over the filled
pockets, and
Inserting the “ sandwich” under a die press where the capsules
are formed and cut out

21. 2. Rotary die press2. Rotary die press
In this process, the die cavities are machined in to the outer
surface of the two rollers.
 The die pockets on the left hand roller form the left side of the
capsule and the die pockets on the right hand roller form the right
side of the capsule.
Two plasticized gelatin ribbons are continuously and
simultaneously fed with the liquid or paste fill between the rollers
of the rotary die mechanism.
As the die rolls rotate, the convergence of the matching die
pockets seals and cuts out the filled capsules.

23. 3. Accogel process3. Accogel process
 In general, this is another rotary process involving
• A measuring roll,
• A die roll, and
• A sealing roll.
 As the measuring roll and die rolls rotate, the measured doses are
transferred to the gelatin-linked pockets of the die roll.
 The continued rotation of the filled die converges with the rotating
sealing roll where a second gelatin sheet is applied to form the other
half of the capsule.
 Pressure developed between the die roll and sealing roll seals and
cuts out the capsules .

24. 4. Bubble method4. Bubble method
 A concentric tube dispenser simultaneously discharges the
molten gelatin from the outer annulus and the liquid
content from the tube.
The liquids are discharged from the concentric tube orifice
into a chilled-oil column as droplets that consists of a liquid
medicament core within a molten gelatin envelop.
 The droplets assume a spherical shape under surface
tension forces and the gelatin congeals on cooling.
The finished capsules must be degreased and dried

25. IN-PROCESS TESTING OF IN-PROCESS TESTING OF
SGCSGC
During the process, capsules are taken
periodically for checking :-
1.Seal thickness
2.Fill weight check
3.Capsule diameter sorter
4.Capsule colour sorter
5.Capsule counting

26. 1.Seal thickness :- is measured under a microscope and
changes in gelatin ribbon thickness, heat or pressure are
made if necessary. Acceptable seal thickness is ½ - 2/3 of
the ribbon thickness.
2.Fill weight check :- are made by weighing the whole
fresh capsule, slitting it open, and the contents are
removed. The shell is then washed in a suitable solvent,
and the empty shell is reweighed. If there is weight
variation, then necessary changes are made in the pump
that measure the weight of the material to be filled.
3.Capsule diameter sorter :- allows to sort and check the
capsules are within the range of ± 0.020 inch of the
theoretical diameter of the capsules. Overfills, underfills,
or foreign capsules are discarded.

27. 4.Capsule colour sorter :- capsules are fed
into the colour sorter automatically from the
diameter sorter. Any capsule whose colour
does not conform to the standard for that
particular product is discarded, while other
capsules that pass the test are accepted.
5.Capsule counting :- here the capsules are
counted, and about 8000 capsules can be
counted per minute. They are then, moved
to further quality control tests of the
finished product.

28. FINISHED PRODUCT TESTING OF
SGC
These normally includes
1.Capsule appearance,
2. Weight Variations
3.Content uniformity
4.Disintegration Test
5.Dissolution Test

29. APPLICATION OF SGCAPPLICATION OF SGC
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.
•It is used in water immiscible, volatile, and non-
volatile liquid such as vegetable and aromatic oils,
aromatic and aliphatic hydrocarbons, ether, esters,
alcohol, and organic acids.
•Solid also encapsulated into soft gelatin capsules as
solution in one of the suitable liquid solvent, as
suspension, or as dry powder, granules, or pelletized
materials.