CAPSULES solid dosage form the drug is enclosed within either a hard or soft shell shell is...
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Transcript of CAPSULES solid dosage form the drug is enclosed within either a hard or soft shell shell is...
CAPSULES• solid dosage form• the drug is enclosed within either a hard or soft shell
shell is typically made of gelatin• primarily intended for oral delivery• provide a rapid release of contents
B. Amsden 1CHEE 440
Gelatin
protein, prepared from hydrolysis of collagen (animal bones and skin) type A : pI = 7-9, pig skin type B : pI = 5, animal bones
possesses 4 essential properties
• stable when dry• subject to microbial degradation when moist• digested and absorbed
B. Amsden 2CHEE 440
Hard Gelatin Capsulescontain 12 - 16 % moisturetypically filled with dry solids
powders granules pellets tablets
also contain colorant preservatives SIZE VOLUME (cm3)
000 1.3700 0.950 0.681 0.502 0.373 0.304 0.215 0.13
B. Amsden 3CHEE 440
Manufacture
B. Amsden 4CHEE 440
http://www.rjengineering.com/process.htm
Filling
operations involved rectification of empty capsules separation of caps from bodies filling capsule bodies replacing caps and ejecting filled capsules
3 basic methods for powder filling auger or screw dosator dosing disc
B. Amsden 5CHEE 440
Capsule Filling
auger• semi-automatic operation• filling based on volume• need good powder flow properties
dosator• fill based on weight• continuous operation
B. Amsden 6CHEE 440
Hard Gelatin Capsules
Advantages tasteless and odorless swallowing is easy flexibility in formulating uniquely suitable for blinded clinical trials useful for extemporaneous compounding by pharmacist
Disadvantages tend to be more expensive to produce than tablets not suitable for highly soluble salts
B. Amsden 9CHEE 440
Soft Gelatin Capsules (Softgels)
• consist of a continuous gelatin shell surrounding a liquid core
• formed, filled, and sealed in one operation• shells are softened by addition of glycerin or
polyhydric alcohol (ex. sorbitol)• oblong, spherical, elliptical in shape
B. Amsden 10CHEE 440