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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. Gelatin. protein, prepared from hydrolysis of collagen (animal bones and skin)
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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 CHEE 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 CHEE 440
Hard Gelatin Capsules • contain 12 - 16 % moisture • typically filled with dry solids • powders • granules • pellets • tablets • also contain • colorant • preservatives CHEE 440
Manufacture http://www.rjengineering.com/process.htm CHEE 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 CHEE 440
Capsule Filling • auger • semi-automatic operation • filling based on volume • need good powder flow properties • dosator • fill based on weight • continuous operation CHEE 440
Capsule Filling • dosing disc • filled based on weight • continuous operation CHEE 440
Bioavailability • factors which influence bioavailability CHEE 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 CHEE 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 CHEE 440
Manufacture CHEE 440
Bioavailability CHEE 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 CHEE 440