Production of Capsule in Pharmaceutical Industry
Capsule
The word capsule is deriving from the Latin word
capsulac meaning a small box. Capsule is the solid unit dosage form of
medication with a separate body & cap (Both are gelatin shells). There are
two types of capsules-Capsule with hard gelatin shell & Capsule with soft
gelatin shell. Hard capsules are filled with powders & pellets, whereas
soft capsules are filled with liquid or semisolid product.
According to British Pharmacopoeia,”
Capsules are the solid dosage form in which the drug is enclosed either in a
hard or soft, soluble container or shell of a suitable form of gelatin”.
In
this pharmaceutical industry filling (encapsulation), sealing and polishing (if
required) of capsules of hard gelatin shell are done during manufacturing, as
the industry does not manufacture any capsule shell.
The active is filled in the empty the hard
gelatin capsule shell in the form of-
Ø Powder
Ø Pellets
Powder
and pellets are encapsulated using hard gelatin shell. Powders to be
encapsulated are pre-compacted and do not need compaction. However, few powders
need to be compacted to increase their flow properties. Different size of shell
is used (0-3) but most abundance shell size used is size two, which are
imported from India and some are locally made.
Source of EHGCS
1.
Global capsule Ltd. Bangladesh.
2.
Chemcaf capsule Ltd – India
3.
Associate capsule Ltd – India
After dispensing of
essential from pharmacy according to FO the manufacturing process take place.
Machines used in
encapsulation:
[ Sejong Encapsulation Machine
Source: Korea
Capacity:
60,000-65,000 cap/hour
[ p + am
Source: India
Capacity: 1, 20, 000 cap/
day
Parts of Encapsulation Machine
Ä Shell
portion contains- magazine
Æ upper
& lower segment/race way
Æ pusher
Æ ejection
filler
Ä The
powder portion contains- nozzles
Ä Polisher
portion contains- vacuum line & Brush
|
The environment control sheet capsule production
room contains the following things:
ü
Temperature level:
ü %
RH
ü Dry
bulb temperature
ü Wet
bulb temperature
ü Date
ü Time
ü Extreme
condition of month-
Ä Maximum
Ä Minimum
ü Remarks
This condition of the encapsulation room is
inspected by production by officers and by the respective officers of QA
department
Capsule Polishing
Not all but most
capsules need polishing. Polishing is done first by machine (p + am) and then
by hand. Towel polish is done with silicone emulsion which removes dust,
adherent powder and gives a shiny appearance.
Problem associated during
encapsulation:
Ä Formulation
of pin hole in the shell
Ä Cap
& body color variation
Ä Brittleness
of the shell
Ä Logo
imprintation
