The document provides an overview of hard and soft gelatin capsules, including their definitions, advantages, disadvantages, and manufacturing processes. It details the steps involved in producing empty gelatin capsules, filling them with solid medicaments, and the components needed for soft gel formulations. Additionally, it describes the composition and methods used to manufacture soft gel capsules, emphasizing the importance of gelatin and various additives.

1. CAPSULE
G A N A P A T H I N A Y A K
P H A R M . D
J A Y A M U K H I C O L L E G E O F
P H A R M A C Y

3. DEFINITIONS
❖Capsules are solid dosage form in which the drug
substance is enclosed in a water soluble shell or an
envelope
❖ a capsule shell is made up of gelatin
❖Primary intended for oral delivery

4. ADVANTAGES DISADVANTAGES
➢The drug having unpleasant taste
and odour can be administered by
enclosing them in a tasteless shell
➢They are smooth become slippery
when moist and can be easily
swallowed
➢The ready solubility of gelatin at
gastric PH provides rapid release
of medicament in the stomach
➢They are attractive in appearence
➢The Hygroscopic drugs can’t be filled in
capsules
➢The concentrated preparations which
need previous dilutionare unsuitable for
capsule because it may lead to irritation
in stomach if administers as such

5. ❖ Gelatin is heterogenous product derived by hydrolyte
extraction of animal collagen
❖ The sources of gelatin including animal bones and
frozen pork skin
❖ Type – A : gelatin is mainly derived from pork skin by
acid treatment
❖ Type – B : gelatin is derived from bones and animal skin
by alkaline process
GELATIN

6. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
1. DIPPING :
▪ pairs of the stainless steel pins are dipped into the dipping
solution to simultaneouslyfrom the caps and bodies.
▪ The dipping solution is maintained at a temperatureof
about 50 degrees centigrade in a heated jacketed dipping
pan.
2. 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.

7. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
3. DRYING :
▪ The capsule 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
4. STRIPPING :
▪ A series of bronze jaws strip the cap and body portions of the
capsules from the pins

8. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
5. TRIMMING AND JOINING :
▪ The stripped cap and body portions are trimmed to the
required length by stationary knives
6. POLISHING :
▪ Pan polishing – Aceta – cota pan is used to dust &
polish
▪ Cloth dusting – capsule are rubbed with cloth
▪ Brushing – capsule are feed under soft rotating
brush

9. ADJUVENTS
▪ In large scale or small preparation of filled Hard gelatin capsule
divided into following steps :
- Developing the capsule shell
- Filling the capsule shell
- Capsule sealing
- Cleaning and polishing the filled capsule
▪ Diluents and fillers : lactose, micro crystalline cellulose,
starch.
▪ Disintegrants : sodium starch , pregelatinizedstarch
▪ Glidants and Lubricants : silicon dioxide , magnesium
stearate,calcium stearate.
▪ Wetting agents : SLS

10. HARD GELATIN CAPSULE
➢ These are used for administration of solid medicaments
➢ The capsule shell is prepared from gelatin ,It consists of two parts i.e.,
body and cap
➢ The powdered material is filled into the cylindrical body of the capsules
and then the cap is placed over it.
➢ Contain 12 – 16 % moisture
➢ Typically filled with dry solids – powers, granules, pellets, tablets
Filling of Hard Gelatin Capsules :
1. Punch method or Manual Filling
2. Hand Filling or Semi Automatic Capsules Devices
3. Automatic Filling Machine

11. Preparation Methods
1. PUNCH METHOD :
❑Powder is placed on a shut of a clean paper or
porcelain plate using spatula which is formed
into a cake having a depth of approx. – one
fourth to one third the level of the capsule
body.
❑Then empty capsule body is held b/w the
thumb and fore finger, punched vertically into
the powder cake repeatedly until filled

12. Preparation Methods
2. Capsule Filling Machine :
❑It consists of…
❑A bed having 200 – 300 holes
❑A loading tray having 200 – 300 holes
❑A power tray
❑A pin plate having a rubber top
❑A lever
❑A cam handle

13. Preparation Methods
3. Automatic capsule Filling Machine :
❑It has been designed and developed to fill Hard
Gelatin capsule with powder or pellets
❑It can be applicable to the widest range of
capsule at all sizes and guarantee the integrity
of all capsule
❑Capsule of filling, 6 capsules at a time with
operation from 10 stations . Accurate operation
for orientation opening, filling, joining and
ejecting of the capsule

14. Finishing of Capsule
➢Cloth dusting :capsule are rubbed with cloth
➢Polishing :
➢Pan polishing – aceta – cola pan is used to dust and
polish which is lined with cheese or a polyurethane
cloth
➢Brushing :capsule are feed under soft rotating brush
➢Sorting :
➢Rotosort – 1,50,000 capsules/ hr

15. SOFT GELATIN CAPSULE
• Soft gelatin capsule are one piece, hermetically sealed, soft gelatin shells
containing a liquid, a suspension, or a semisolid.
Composition of shell of Soft gel Capsule :
• The capsule shell is basically composed of gelatin,
a plasticizer and water. It may contain additional
ingredients such as preservative, coloring and
opacifying agents, flavoring agents, sugars, acids
and medicaments to achieve desired effects.

16. SOFT GELATIN CAPSULE
1. capsule shell water :
• NMT 45% w/w the ratio by weight of water to
dry gelatin can vary from 0.7% to 1.3[water] to
1.0 [dry gelatin] depending on the viscosity of
the gelatin being used.
2. Plasticizer :
• Used to make the soft gel shell elastic & pliable
• Ratio used is b/w 0.3 to 1.8 for soft to hard
shell on dry basis Ex :- glycerin, sorbitol.

17. SOFT GELATIN CAPSULE
3. Color :
• Used in shell has to be darker than color of encapsulating
material color may be natural or synthetic
4. Opacifier :
• Usually titanium dioxide, may be added to produce an
opaque shell.
• When the fill formation is a suspension or to prevent photo
degradationof light sensitive fill ingredients

18. SOFT GELATIN CAPSULE
5. Chelating agent :
• Iron is always present in raw gelatin,
should not contain iron more than
15ppm
• Additionally chelating agent may be
used for preventing the reaction of
iron with materials or colors.

19. Manufacture of soft gelatin capsule
1. Plate process :
❖A warm sheet of gelatin is placed on the bottom plate of
mold
❖The liquid medicament is poured on it
❖Then the 2nd sheet of the prepared gelatin is carefully laid in
place on top of the medicament, and the top plate of the
mold is put in place
❖The entire mold is then subjected to a press where pressure is
applied to form fill and seal the capsule simultaneously
❖Then the capsule is removed

20. Manufacture of soft gelatin capsule
2. Rotatory Machine :
❖ In this process the die cavities are machined into the outer
surface of the two rollers
❖ Gelatin is properly weighed & dispensed in melting
temperature under vacuum of 93’c
❖ Two plasticizedgelatin ribbons are continuously and fed
with the liquid or paste fill b/w the rollers of the rotatory
die mechanism
❖ As the die rolls rotate, the convergence of the matching die
packets seals & cuts out the filled capsules

21. Manufacture of soft gelatin capsule
3. Accogel capsule Machine :
❖ It consists of 3 parts : 1. measuring roll
2. die roll
3. sealing roll
❖ As the measuring roll and die rolls rotate, the measured doses
are transferred to the gelatin – linked pocket of the die roll.
❖ The continued rotation of the filled die converges with the
rotating sealing roll where a 2nd gelatin sheet is applied to form
the other half of the capsule
❖ Pressure developed b/w the die roll and sealing roll seals and
cuts out the capsules