⦿

⦿
✔ Animal protein, mainly gelatin
✔ Plant polysaccharides or their derivatives like
carrageenans and modified forms of starch and
cellulose.
✔ Other ingredients can be added to the gelling agent
solution like:
❑plasticizers such as glycerin or sorbitol to
decrease the capsule's hardness,
❑coloring agents,
❑preservatives,
❑disintegrants,
❑Lubricant
❑surface treatment
1. Gelatin
2. Certified dyes
3. Sugar
4. Water - 12 to 16 % but may vary depending on the
storage condition
5. Sulfur dioxide (0.15%) - prevent decomposition
during manufacture
6 Opaquants /Opacifying agent - titanium dioxide
Gelatin or gelatine (from Latin: gelatus
meaning "stiff", "frozen") is a translucent,
colourless, brittle (when dry), flavourless
foodstuff, derived from collagen obtained from
various animal by-products.
It is commonly used as a gelling agent in food,
pharmaceuticals, photography, and cosmetic
manufacturing.
Gelatin is an irreversibly hydrolyzed form of
collagen
TYPE
A
Derived from acid treated precursor that exhibits an
iso electric point at pH-9. It is manufactured mainly
from animal bones
TYPE B
Derived from alkali treated precursor that exhibits an
iso electric point at pH-4.7. It is manufactured
mainly from pork skin
 HARD GELATIN CAPSULES

•Also referred to as “DFC” Dry Filled Capsule. CAPSULE SIZES:

•For human use, empty capsules ranging in size from 000 (the largest) to
5
•(the smallest) are commercially available.
•Generally encapsulates between 65mg to 1g of powdered material.

•For veterinary use: No's 10, 11and 12 having capacities of 30, 15 and
7.5 g, respectively
⦿

⦿
⦿

⦿
⦿
⦿

⦿
 Steps involved in making empty gelatin capsules
with peg/pin method…

1.Dipping 2.Spinning 3.Drying 4.Stripping

5. Trimming and Joining
6. Polishing

•
 DIPPING :
Pairs of the stainless steel pins are dipped into the dipping solution to
simultaneously form the caps and bodies.
The dippin solution is maintained at a temperature of about 50 degree
centigrade in a heated ,jacketed dipping pan.

• SPINNING:
The pins are rotated to distribute the gelatin over the pins unifomly and to
avoid the formation of a bead at the capsule ends.

• 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.
 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.

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.

• During production the thickness of the capsule wall is controlled by the viscosity
of the gelatin solution, speed and time of dipping.
• Empty capsules should not be subjected to temperature above 38 ºC (might
destroy the capsule shells such that they can not be handled in the Filling
equipments)
• Empty capsules should maintain moisture Content between 12% and 15%.
Below 10% they become brittle
Above 16% they might increase in size (causing problems inthe filling
equipment) or they might become soft.
❑

❑
 Hard capsule FILLING

1) Bench scale filling.(for small scale filling)

- Manual filling machine
eg: feton capsule filling machine
2) Industrial scale-filling.
Comes in varying shapes and sizes
- semi automatic machine
- fully automatic machine
•

▪
▪
▪
▪
▪
▪
▪
▪
▪
❑

❑
 HAND OPERATED CAPSULE FILLING
MACHINE
✔

✔
✔

✔
•
❑

❑
❑
Lilly/Parke-Davi
s
Rectifying unit
Two piece filling ring

Powder hopper

Peg ring

Closing plate

Collecting chamber
•
 FARMATIC SNC

Farmatic offers three models of filling equipments

Model

2000/15 40000 capsules

per hour
2000/30 80000 capsules
per hour
2000/60 160000
capsules per
hour
⦿ MANUAL FILLING
METHOD(PUNCH METHOD)

⦿ HAND OPERATED METHOD

⦿ AUTOMATIC OPERATED FILLING

MACHINES
Used for filling a small number of capsules in the pharmacy,
at the prescription counter.

The ingredients are triturated to fine & uniform powder.

The powder is placed on a powder paper or ointment slab
and smoothed with a spatula to a height approximately half
the length of the capsule body
▪The base of the capsuleis held vertically andthe open end
is
repeatedly pushed or "punched" into the powder until the capsuleis
filled;
▪The cap is then replaced to close the capsule. Each filled capsule is

weighed using an empty capsule as a counterweight.

▪Powder is added or removed until the correct weight has

been
placed in the capsule.
▪The filled capsule is tapped so that no air spaces are visible within the

contents
⦿ Pharmacists that prepare capsules on a regularor
extensive basis

may use hand-operated capsule machines.

⦿ These machines are available in capacities of 24, 96, 100, and

144 capsules.

⦿
⦿ Machines developed for industrial use can automatically
remove the caps from empty capsules, fill the capsules,
replace the caps, and clean the outside of the capsules
at a rate of up to capsules and greater per
hour.
⦿ TAMPER-EVIDENT CAPSULES

⦿ DISTINCTIVE LOOKING CAPSULES

⦿ HEA T WELDING PROCESS

⦿ LIQUID WETTING AGENT

⦿

⦿ (ACCELACOTA APPARATU..S)
⦿ Hard gelatin capsules are stored in a
tightly closed glass or plastic
containers, protected from dust and
extremes of humidity and temperature.
⦿
These capsules contain 12 - 16% water but
water content vary according to the storage
conditions.
Capsules become brittle in low humidity but are
flaccid and lose their shape if stored in high
humidity.
They do not protect hygroscopic materials from
atmospheric water vapor as moisture can
diffuse through the gelatin wall. When storage
temperature condition is high the quality of the
hard gelatin capsules are affected
⦿

⦿
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⦿
Types of
softgels

.
▪

▪
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