Saturday, December 8, 2012

Production of Capsule in Pharmaceutical Industry

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
250 + 20 to 350 + 20 C
 
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




7 comments:

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