2. ►Capsules are
Capsules are solid dosage forms with
solid dosage forms with
hard or soft shells. They are of various
hard or soft shells. They are of various
shapes and sizes, and contain a single dose
shapes and sizes, and contain a single dose
of one or more active ingredients. They are
of one or more active ingredients. They are
intended for oral administration.
intended for oral administration.
►In capsules the drug is enclosed within hard
In capsules the drug is enclosed within hard
or soft shell.
or soft shell.
3. Capsule shells are made of gelatin or
Capsule shells are made of gelatin or
other substances, the consistency of which
other substances, the consistency of which
may be modified by the addition of
may be modified by the addition of
substances such as glycerol or sorbitol.
substances such as glycerol or sorbitol.
The shell should disintegrate in the
The shell should disintegrate in the
presence of digestive fluids so that the
presence of digestive fluids so that the
contents are released.
contents are released.
The contents should not cause
The contents should not cause
deterioration of the shell.
deterioration of the shell.
4. Excipients for production
Excipients for production
of the Capsule shells :
of the Capsule shells :
diluents,
diluents,
solvents,
solvents,
surface-active substances,
surface-active substances,
opaque fillers,
opaque fillers,
antimicrobial agents,
antimicrobial agents,
sweeteners,
sweeteners,
colouring matter,
colouring matter,
flavouring substances,
flavouring substances,
disintegrating agents,
disintegrating agents,
glidants,
glidants,
lubricants,
lubricants,
substances capable of modifying the behaviour of the active
substances capable of modifying the behaviour of the active
ingredient(s) in the gastrointestinal tract.
ingredient(s) in the gastrointestinal tract.
6. Type of capsules depend on
Type of capsules depend on
plasticizer content
plasticizer content
and technological principle
and technological principle
1. Hard-Shell Gelatin Capsules;
1. Hard-Shell Gelatin Capsules;
2. Soft- Gelatin Capsules
2. Soft- Gelatin Capsules
(
(softgels
softgels);
);
7. Soft gelatin capsules (softgels) are hermetically
sealed one-piece capsules containing a liquid or
a semisolid fill.
Soft capsules are usually formed, filled, and
sealed in one operation.
8. 8
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.
9. 9
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
11. Advantages
of soft-gelatin capsules
1. Improved bioavailability, as the drug is presented in a
solubilized form.
2. Enhanced drug stability.
3. Consumer preference regarding ease of swallowing,
convenience, and taste can improve compliance.
4. Offer opportunities for product differentiation via colour,
shape, and size and product line extension.
5. The softgels can be enteric coated for delayed release.
They are popular for pharmaceuticals, cosmetics, and
nutritional products.
12. Hard capsules have shells consisting of two
prefabricated cylindrical sections that fit
together.
One end of each section is rounded and closed,
and the other is open. The contents of hard
capsules are usually in solid form (powder or
granules).
13. In the manufacture of capsules,
measures are taken to:
ensure that the active ingredient(s) when
present in solid state form have appropriate
solid-state properties such as particle-size
distribution and polymorphic form;
ensure that mixing with excipients is carried
out in a manner that ensures homogeneity;
minimize the degradation of the active
ingredient(s);
minimize the risk of microbial contamination;
minimize the risk of cross contamination.
14. Stage of capsules production:
1. Preparing of gelatin
solutions.
2. Preparing of gelatin
shells.
3. Hard-gelatin
capsule filling.
4. Packing and
labeling.
1. Preparing of gelatin
solutions.
2. Preparing and filling
of soft-gelatin
capsules.
3. Packing and
labeling.
16. Droplet method
1. Container with
medicines substance
2. Hoper with
medicines substance
3. Container with
gelatin solution
4. Conical nozzle
5. Pulsater
6. Cooler
7. Container with
Vaseline oil
17. Characteristic of Droplet
method
It is based on formation of spherical
gelatinous drop filled with a solution or
suspension of medicinal substance at
simultaneous drop dosage of medicinal
substance solution followed by subsequent
cooling of heated gelatinous mass in cool
liquid petrolatum. As the result joinless
spherical gelatious capsule with elastic
shell is formed.
18. Droplet method
1. Container with
medicines substance
2. Hoper with
medicines substance
3. Container with
gelatin solution
4. Conical nozzle
5. Pulsater
6. Cooler
7. Container with
Vaseline oil
19. Pressing method
Preparing of an initial gelatinous
tape, placing it into metal plates
and rolls having deepening holes
resembling half of the capsules.
While heating gelatin fills this
mould. Drug is fed into a hollow
in a gelatinous tape, then this
half of a capsule is joined with
another one formed and filled in
the same way. Obtained
capsules have a horizontal weld.
20. Pressing (rotate die)
method
The glycerol – gelatin solution is heated
and pumped onto two chilled drums-1
to form two separate ribbons-2, which
form each half of the softgel.
The ribbons are lubricated and fed into
the filling machine, forcing the gelatin
to adopt the contours of the die.
The fill-4 is manufactured in a separate
process and pumped in, and the
softgels are sealed by the application
of heat and pressure.
Once cut from the ribbon (5), they are
tumble - dried and conditioned at
20 % relative humidity.
21. APPLICATION OF SOFT GELATIN CAPSULE:
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.
21
22. Difference between Hard and Soft Gelatin
Capsule
Features Hard Gelatin Capsule Soft Gelatin Capsule
Structure Composed of two parts-
1) Body, 2) Cap
Composed of a Single part.
Composition
of Shell
Composed of gelatin
blends, dyes ,
plasticizers and water.
Gelatin, plasticizers and
water
State of
Medicament
s
Only solid medicaments
are enclosed
Solid, semi-solid
medicaments are enclosed
Shape and
Size
Capsule shell is
cylindrical
Capsule shell may be
round, oblong, oval
23. Difference between Hard and Soft Gelatin
Capsule
Features Hard Gelatin Capsule Soft Gelatin Capsule
Thickness Less thicker Thicker
Routes of
administration
Only orally Oral, Opthalmic,
Suppository
Sealing Not completed sealed Completely sealed
Manufacturing Can be made by hand,
semiautomatic or
automatic machine.
Not by hand.
