3. DEFINITION:-
These are solid dosage form ofmedicaments,
in which drug and some other ingredients is
enclosed within the shells made up of gelatin.
4. ADVANTAGES OF CAPSULES
• Capsules mask the taste and odour of unpleasant drugs
and can be easily administered.
• They are slippery when moist and hence easy to swallow
with a draught of water.
• As compared to tablets less adjuncts are required.
• The shells are physiologically inert and easily and
quickly digested in the gastrointestinal tract.
• They are economical .
• They are easy to handle and carry.
5. DISADVANTAGES OF CAPSULES
The drugs which are hygroscopic absorb water
from the capsule shell making it brittle and hence are
not suitable for filling into capsules.
The concentrated solutions which require previous
dilution are unsuitable for capsules because if
administered as such lead to irritation of stomach.
6. These capsules are made up of gelatin blends,
small amount of certified dyes, opaqueness ,
plasticizers and preservatives.
7. Certified Dyes
Colour approved by D & C act.
Opacifiers
Titanium dioxide.
Plasticizers
Sorbitol, Glycerin.
Preservatives
Propyl and Methyl Parabens.
8. 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
GELATIN
9. TYPE A
Derived from acid treated precursor that
exhibits an iso electric point at pH-9. It is
manufactured mainly from pork skin. Plasticity
and clarity
TYPE B
Derived from alkali treated precursor that
exhibits an iso electric point at pH-4.7. It is
manufactured mainly from animal bones .
tough and brittle
11. Steps involved in making empty gelatin
capsules…
Dipping
Spinning
Drying
Stripping
Trimming and Joining
Polishing.
12.
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 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.
14. 14
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.
15. 15
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.
16. 16
Size Volume in ml Size in mm
000 1.37 26.3
00 0.95 23.7
0 0.68 21.8
1 0.50 19.2
2 0.37 18.3
3 0.30 15.3
4 0.21 14.7
5 0.15 11.9
17. 17
*The largest size of the capsule is No: 000.
*The smallest size is No: 5.
*The standard shape of capsAules is traditional,
symmetrical
bullet shape.
18. Types materials filling into hard
gelatin capsules
Dry solids : powder, pellets, granules
Semisolids : suspensions or pastes
Liquids : non aqueous liquids
Filled by depending up on the capsule
size
19. FILLING OF HARD GELATIN
CAPSULES
• Hand operated hand gelatin capsule
filling method
A hand gelatin capsule filling machine consists of
• A bed with 200 – 300 holes
• A capsule loading tray
• A powder tray
• A pin plate having 200 – 300 pines
number of holes on the bed and capsule loading tray
• A lever
• A handle
• A plate fitted with rubber
20. 20
Various Filling Machine Available…
Eli-lily and Co.
Farmatic.
Hofliger and Karg.
Zanasi.
Parke-Davis.
These machine differ in there design and
output
22. Filling capsule with a
semisolid mass
1. Pipe
materials are sufficiently plastic .it can be rolled in to a
adjustable diameter of pipe with slightly less diameter in to
the capsules .the materials are through in to the capsules
with the help of spatula or knife
2.Semisolid pour
it’s a easy method compared to pipe method because of
in pipe method maintain the satisfactory temp other wise
its make a melting its difficult to pour and seriously
change the cap
24. 24
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
26. 26
1. STABILITY TESTS.
a) Shell integrity test
b) Determination of shelf life
2.INVARIABILITY TESTS.
a ) Weight variation
b) Content uniformity
3. DISINTEGRATION TEST.
4. DISSOLUTION TEST.
5. MOISTURE PERMEATION TEST.
27. Stability tests for capsules are performed to know
the integrity of gelatin capsule shell ( but not to
know the stability of therapeuticallay active agent )
and for determining the shelf life of capsules.
The tests helps in improving the quality of contents
of capsule shell and for choosing the appropriate
retail package.
BEFORE ACTUALLY PERFORMING THE TESTS
FOLLOWING FACT:
(i).the capsule shell are to be stabilized to know
atmospheric condition with relative humidity
about 20-30 % and temperature about 21-24⁰c .
27
28. A ) SHELL INTEGRITY TEST :
▪ This test is performed to find out the integrity of
capsule shell.
The standard capsule shells kept at the room
temperature 40 ⁰c and 80% RH becomes more
soft ,sticky and swollen .
B) DETERMINATION OF SHELF
LIFE :
Shelf life or the expiry date of packed capsules is
determined under normal storage conditions.
28
29. The invariabilty in the medicaments packed in
the
capsule shells can be determined by performing
the
following tests :
a) Weight variation test
b) Content uniformity test
29
30. FOR HARD CAPSULES
weigh 20 capsules individually and determine the avg weight
The individual weight should be with in limit of 90-110% of avg weight
If not all of capsules fall with in the limits,
Weigh 20 capsules individually
Remove the net content of each capsule with the aid of a small brush
Weigh the empty shells individually
NET WT OF CONTENTS INDIVIDUALLY =
THE WT OF SHELL-GROSS WT
31. Determine the avg net content from the sum of individual
net weight
Then determine the difference b/w each individual net
content and avg net content
32. 10 capsules are taken and subjected to assay
9 of 10 capsules should be in the range of +_15%
(85-115%)
And 10th capsule are beyond +_ 15% range then
20 capsules are assayed
All capsules with in range of +_25% (75-125%)
CONTENT UNIFORMITY
33. Disintegration test is a method to evaluate the
rate of disintegration of solid dosage forms .
disintegration is defined as the breakdown of
solid dosage form into small particles after it is
ingested .
33
34. ▪ Dissolution test is an official method to
determine the dissolution rate of a solid dosage
form .
▪ Dissolution rate is defined as the rate at which
the drug is released into the systemic
circulation from the dosage from .
34
35. 35
a) . Apparatus -1 ( rotating basket dissolution
apparatus ) :-
▪Small wire mesh size basket – 22
▪Temperature – 37 +/- 5⁰c
▪Rotated speed – 25 -150 rpm
▪Dissolution medium hight from the
bottam of the vessel :- 23-27 mm
36. b) Apparatus -2 ( rotating paddle dissolution
apparatus) :-
Small wire mesh size :- 22
Dissolution medium hight from the
bottam of the vessel :- 23-27 mm
▪Temperature – 37 +/- 5⁰c
▪Rotated speed – 25 -150 rpm
▪Dissolution medium hight from the
36
37. To assure the suitability of containers for
packaging capsules .
The moisture permeating feature of capsules
packaged in
▪ single unit containers – blister pack or strip pack
▪ unit dose containers – glass or plastic bottles
Are to be determined .
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