Capsules

(Dr.) Mirza Salman Baig

Assistant Professor (Pharmaceutics)
AIKTC, School of Pharmacy,New Panvel
Affiliated to University of Mumbai (INDIA)

Defination
"Solid Unit dosageform for internal
use in which drug or mixture of drug
enclosed in hard or soft gelatin shell"

Advantage
Capsules are tasteless, odorless and can easily be
administered.
Combination of powders we can used
They are attractive in appearance.
Those drugs having un/ pleasant odor 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.

Capsule size
For human use, empty capsules ranging in size from 000 the
largest to 5 the smallest. Generally, hard gelatin capsule are
used to encapsulate between 65 mg to 1 gram.

Gelatin
Gelatin is heterogeneous product
derived by hydrolytic extraction of
animal's collagen.
TYPES OF GELATIN
Type A
Derived from acid treated precursor that exhibits an
iso electric point at pH/ 9. It is manufactured from
pork skin.

Type B
Derived from alkali treated precursor that exhibits an
iso electric point at pH-4.7. It is manufactured mainly
from animal bones

Making Hard Gelatin

capsules
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming
6.Joining
7.Polishing

Contd...
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.

Contd...
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 moisture
Stripping :
A series of bronze jaws strip the cap and
body portions of the capsules from the
pins.

Contd...
Trimming and joining
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.
Vid

Contd...
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.

Hard Gelatin Capsule shell

Moisture content 12-15%
below 10% they become brittle
abovbe 16% they become soft

The capsule is soft because it contains a large

proportion of a plasticizer.
This can be varied to produce capsules for
different applications.
The plasticizer which is most frequently used is
glycerol, sorbitol, propylene glycol, sucrose and
acacia have been used also.
The pigment used are of two types.
Titanium dioxide
Oxide of iron; three are used : black, red and yellow.

Steps in Capsule Manufacturing

Developing and preparing formulation.
Filling the capsule shell
Capsule sealing
Cleaning and polishing the filled capsules.

Formulation
Diluents and fillers: lactose,
microcrystaline cellulose, starch.
Disintegrants: sodium starch
glicolate ,pregelatinised starch
Gligants and lubricants: silicon
dioxide,magnesium stearte,calcium
stearate
Wetting agents: SLS

Capsule filling
Hand Operated methods.
ex: feton capsule filling machine

Semi Automatic Capsules Devices.

Automatic filling machine.
machine

ex: osaka capsule filling machine ,macofar capsule filling

HAND OPERATED
CAPSULE FILLINGMACHINE
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 handel

Sealing
1. Tamper evident capsules by sealing the joint
between the 2 capsule parts
2. Distinctive looking capsules by sealing them with
colored band of gelatin (Kapseals). 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

Vid

Example: Welds gelatin seal

Soft Gelatin Capsule

Contd...
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.
Gelatin:Plasticizer (0.8:1)----->Soft G Capsule
Gelatin:Plasticizer (0.4:1)----->HardG Capsule

The shape of soft

gelatin capsule are
round, oval, oblong,
tube.

20

Manufacturing Soft Gelatin Capsule

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 from 0.3-1.0 for very hard shell to
1.0-1.8 for very soft shell
Up to 5% sugar may be included to give a
chewable quality to the shell
Water:dry gelatin (1:1)

2. Formulation :

Materials are generally formulated to produce

the smallest possible capsule consistent with
maximum stability, therapeutic effectiveness
and manufacture efficiency.
Emulsion can not be filled because water will
be released that will affect the shell
Useful for semisolids
The pH of the liquid can be between 2.5 and
7.5.

Manufacture of soft gelatin

capsule
Is manufactured by four methods
1)Plate process
2)Rotary die process
3)Reciprocating die
4)Accogel machine

Plate Processes
Place 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, and
Sandwich under a die press where the
capsules are formed and cut out.

Rotary die press

In this machine the soft gelatin capsules are
prepared & then filled immediately with
liquid medicaments it is having two hoppers
& two rotating dies
Liquid mixture is placed in one hopper & the
liquid medicament in other Hooper.
The two rotating dies rotate in opposite
directions when the fluid gelatin mixture
enters the machine from the hopper it
produces two continuous ribbons .
These half shell of the capsule is formed.

Contd...
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.
The two halves' of the capsules are
sealed together by the heat & pressure
of the rotating dies
As the die rolls rotate, the convergence of
the matching die pockets seals and cuts
out the filled capsules

Rotary die machine

HARD GELATIN CAPSULE

SOFT GELATIN CAPSULE

1) Two piece (large body &

short cap)

1)

One piece & hermetically

sealed.

2)

Cylindrical shape.

2)

Available in round , oval

& tube like shapes.

3) Powder drug or pallets

coated with drug are
encapsulated.

3)

Liquid & Semi liquid fill &

unstable substances are
encapsulated.

4)

Molten gelatin are used.

5)

Filling & sealing of soft

gelatin capsules are done
in a combined operation
on machine.

6)

No specific sizes are

available.

4) Gelatin in Hard form 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.

6) 8 different type of sizes

are available

EVALUTION OF CAPSULES

WEIGHT VARIATION TEST

CONTENT UNIFORMITY TEST
DISSOLUTION TEST
DISINTEGRSTION TEST

Weight variation test:

In which 20 capsules are individually
weighedand standard deviation from
mean weight wasmeasured 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.