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

Capsule Filling dosing disc

• filled based on weight• continuous operation

B. Amsden 7CHEE 440

Bioavailability

factors which influence bioavailability

B. Amsden 8CHEE 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

Manufacture

B. Amsden 11CHEE 440

Bioavailability

B. Amsden 12CHEE 440

Soft Capsules

ADVANTAGES may contain liquids, suspensions, pastes rapid release of contents useful for drugs prone to oxidation

DISADVANTAGES have a greater tendency to adhere to each other more expensive increased possibility of interactions between drug and shell

B. Amsden 13CHEE 440