Its All About Capsule... i tried to explain in short... hope you liked it.. please like and share to all students, which are want to more study in minimum time.. Thank You.. also join on whatsapp to bring newthings contact no. 9765763626

1. PRESENTATION ON CAPSULE
Presented By :- Natique Ali Mushtaque Ali Sayyed
Roll No. :- 27753
Guided By :- Dr. K.B. Gabhane
VIDYABHARTI COLLEGE OF PHARMACY, AMRAVATI 444602
2019-2020

2. CAPSULE

3. INTRODUCTION
Capsules are solid dosage forms in which drug substance is enclosed within
hard or soft shell. The shells are generally formed from gelatin.
Capsules are of two types
1. Hard Gelatin Capsules
2. Soft Gelatin Capsules

4. ADVANTAGES
Capsules are tasteless, odourless, and can easily be administered.
Combination of powders we can use.
There are attractive in appearance.
The drugs having unpleasant odour and taste are enclosed in a tasteless shell.
They can be filled quickly and conveniently.
They are economical.
They are easy to handle and carry.

5. DISADVANTAGES
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.

6. CAPSULE SIZE
For human use empty capsules ranging in size from 000 the largest to 5 the
smallest. Generally, hard gelatin capsules are used to encapsulate between 6.5mg to
1gm
Size Volume in ml Size in mm
000 1.37 26.1
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

7. GELATIN
Gelatin is heterogeneous product derived by hydrolytic extraction of animals
collagen.
The sources of gelatins including animal bones, hide portions and frozen pork skin.
TYPES OF GELATIN
1. Type A
2. Type B

8. THERE ARE TWO BASIC TYPES OF GELATIN
Type A
Derives from acid treated precursor that exhibits an isoelectric point at pH-
9. It is manufactured mainly from pork skin.
Type B
Derived from alkali treated precursor that exhibits an isoelectric point at pH-
4.9. It is manufactured mainly from animal bones.

9. MANUFACTURING OF HARD GELATIN CAPSULES
Steps involving in making empty gelatin capsules..
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming and Joining
6.Polishing

10. 1. DIPPING:-
Pairs of stainless still pins are dipped into the dipping solution to simultaneously from
the caps and bodies. The dipping solution is maintained at temperature of a about 50oC in a
heated dipping pan.
2. Spinning:-
The pairs are rotated to distribute the gelatin over the pins uniformly and to avoid
the formulation of a bead at the capsule ends.
3. 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

11. 4. Stripping:-
A series of bronze jaws strip the cap and body portions of the capsules
from the pins.
5. Trimming and Joining:-
The stripped and body portions are trimmed to the required
length by stationary knives.
After trimming to the night length, the cap and body portion
are joined and ejected from the machine.
6. Polishing
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

12. PREPARATION OF FILLED HARD GELATIN
CAPSULES:
In large scale or small preparations of filled hard gelatin capsules divide into
the following general steps.
Developing and preparing formulation.
Filling the capsule shell.
Capsule sealing.
Cleaning and polishing the filled capsules.

13. DEVELOPING AND PREPARING THE FORMULATION
Diluents and fillers: lactose, microcrystalline cellulose, starch.
Disintegrants: Sodium starch glicolate, pregelatinised starch.
Gligants and lubricants: silicon dioxide, magnesium sterate, calsium sterate.
Wetting agents: Sodium Lauryl Sulphate (SLS)

14. FILLING OF HARD GELATIN CAPSULES
1. Hand operated Methods
eg. Fecton capsule filling machine
2. Semi Automatic Capsules Devices.
3. Automatic Filling Machines.
eg. Osaka capsule filling machine, macofar capsule filling machine

15. HAND OPERATED CAPSULE FILLING MACHCHINE..
It is having following parts..
a] Bed Having 200-300 holes.
b] loading tray having 200-300 holes.
c] powder tray
d] pin plate having 200-300 pins.
e] Sealing plate having rubber top.
f] lever
g] cam handle

19. CAPSULE SEALING
1. Tamper evident capsules by sealing the joint between the capsule parts
2. Distinctive looking capsules by sealing them with coloured band of gelatin
(Capseals). If removed, the band cannot be restored without expert sealing with
gelatin.
3. Through a heat welding process that fuses the capsule cap to the ring around the
capsule where heat welded. Example: Weld’s Gelatin Seal
4. Capsules may also be sealed through a heat welding process that fuse capsule
cap to the body
5. Lightly coating the inner surface of the cap with a warm gelatin solution
immediately prior to placement on the filled capsule body

20. SOFT GELATIN CAPSULES

21. DEFINATION
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 agent, flavouring agents and sugars.

22. SHAPE OF CAPSULES
The shape of capsules are round, oval, oblong, tube.

23. MANUFACTURING OF SOFT GELATIN CAPSULES
1. Composition of the shell
The basic component of soft gelatin shell is gelatin; however, the shell has been
plasticize.
The ratio of dry plasticizer to dry gelatin determines the ‘hardness’ of the shell and
can vary 0.3-1.0 for very hard shell and 1.0-1.8 for very soft shell.
Up to 5% sugar may be included to give a ‘chewable’ quality to the shell.
The residual shell moisture content of finished capsules will be in range of 6-10%

24. FORMULATION
Formulation for the soft gelatin capsules involves liquid, rather than powder
technology.
Materials are generally formulated to produce the smallest possible capsule
consistent with maximum stability, therapeutic effectiveness and manufacture
efficiency.
The liquids are limited to those that do not have an adverse effect on gelatin walls.
Emulsion cannot be filled because that do not have an adverse effect on gelatin
walls.
The pH of the liquid can be between 2.5 – 7.5.

25. MANUFACTURE OF SOFT GELATIN CAPSULES
Is manufactured by four methods:-
1) Plate Process
2) Rotary Die Process
3) Reciprocating Die
4) Accogel Machine

26. PLATE PROCESS
Plate the gelatin sheet over a die plate containing numerous die pockets.
Application of vacuum to draw the sheet in to the die pockets.
Fill the pockets with liquid or paste.
Place another gelatin sheet over the filled pockets.
Sandwich under die press where the capsule are formed and cut out.

27. ROTARY DIE PRESS
1] In this machine the soft gelatin capsules are prepared and then filled immediately with liquid
medicaments it is having two hoppers and two rotating dies.
2] liquid mixture is placed in one hopper and the liquid medicament in other hopper.
3] The two rotating dies rotate in opposite directions when the fluid gelatin mixture enters the
machine from the hopper. It produce two continuous ribbons.
4] These half shell of the capsule is formed.
5] At this stage the measured quantity of the medicament is filled in to it with the stroke of a
pump with the subsequent movement of the dies the other half capsule is formed.
6] The two halves of the capsules are sealed together by the heat and pressure of the rotating
dies.
7] As the die rolls rotate, the convergence of the matching die pockets seals and cuts out the
filled capsule

28. ROTARY DIE MACHINE

29. ACCOGEL CAPSULE MACHINE
Accogel capsule machine or Stem machine, uses a system of rotary
dies but is unique in that it is the only machine that can successfully fill dry powder into
a soft gelatin capsule.

30. VEHICLES USED IN SOFT GELATIN CAPSULES:
All liquids used for filling must flow by gravity at a temp. of 350C or less
The sealing temperature of gelatin films in 37-400C
Two main groups:
1] Water Immiscible
volatile or more likely more volatile liquidssuch as vegetable oils,
mineral oils, medium-chain tryglycerides and acetylated glycerine.
2] Water Miscible
Non-volatile liquids such as low molecular weight PEG have come in
contact in to use more recently because of their ability to mix with water and accelerate
dissolution of dissolved or suspended drugs.

31. HARD GELATIN CAPSULE SOFT GELATIN CAPSULE
1] Two pieces (Large body & short cap) 1] One piece
2] Cylindrical shape 2] available in round, oval & tube like shape
3] Powder drug or pellets coated with drug are
encapsulated.
3] Liquid and semi-liquid fill and unstable substances
are encapsulated.
4] Hard gelatin is used. 4] Molten gelatin is used.
5] capsules are sealed after they are filled to ensure
that the medicaments may not come out of the capsule
due to rough handling.
5] filling and sealing of soft gelatin capsules are done
in a combined operation on machine.
6] 8 different types of sizes are available 6] No specific sizes are available

32. EVALUATION OF CAPSULES
Weight Variaton Test
Content Uniformity Test
Dissolution Test
Disintegration test

33. Weight variation test:
In which 20 capsules are individually weighed
and standard deviation from mean weight was measured that should not be <90% or 110%
Content Uniformity:
The amount of active ingredient should be within the
range of 85% to 115% of the label amount for 9 of 10 capsules, with no unit outside the
range of 70% to 125% of label amount

34. THANK YOU