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. Amsden1CHEE 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. Amsden2CHEE 440

Hard Gelatin Capsules contain % moisture typically filled with dry solids  powders  granules  pellets  tablets also contain  colorant  preservatives B. Amsden3CHEE 440

Manufacture B. Amsden4CHEE 440

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. Amsden5CHEE 440

Capsule Filling  auger semi-automatic operation filling based on volume need good powder flow properties  dosator fill based on weight continuous operation B. Amsden6CHEE 440

Capsule Filling  dosing disc filled based on weight continuous operation B. Amsden7CHEE 440

Bioavailability factors which influence bioavailability B. Amsden8CHEE 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. Amsden9CHEE 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. Amsden10CHEE 440

Manufacture B. Amsden11CHEE 440

Bioavailability B. Amsden12CHEE 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. Amsden13CHEE 440