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Download week07.1.capsules 2004
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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 1 Gelatin protein, prepared from hydrolysis of collagen (animal bones and skin) possesses 4 essential properties stable when dry subject to microbial degradation when moist digested and absorbed CHEE 440 type A : pI = 7-9, pig skin type B : pI = 5, animal bones 2 Hard Gelatin Capsules contain 12 - 16 % moisture typically filled with dry solids contain CHEE 440 powders granules pellets tablets colorant preservatives 3 Hard Gelatin Capsules come in 2 sections - body and cap may be colored may have a tamper-proof band can be self-locking (ex. Coni-Snap) come in varying sizes SIZE 000 00 0 1 2 3 4 5 CHEE 440 VOLUME (cm3) 1.37 0.95 0.68 0.50 0.37 0.30 0.21 0.13 4 Manufacture CHEE 440 5 Filling operations involved 3 basic methods for powder filling CHEE 440 rectification of empty capsules separation of caps from bodies filling capsule bodies replacing caps and ejecting filled capsules auger or screw dosator dosing disc 6 Capsule Filling CHEE 440 auger » semi-automatic operation » filling based on volume » need good powder flow dosator » fill based on weight » continuous operation 7 Capsule Filling CHEE 440 dosing disc » filled based on weight » continuous operation 8 Bioavailability factors which influence bioavailability disintegration rate » at body T, gelatin dissolves CHEE 440 drug particle size 9 Factors Influencing Bioavailability concentration of lubricants and glidants packing density of powder CHEE 440 10 Hard Gelatin Capsules Advantages Disadvantages CHEE 440 tasteless and odorless swallowing is easy flexibility in formulating uniquely suitable for blinded clinical trials useful for extemporaneous compounding by pharmacist tend to be more expensive to produce than tablets not suitable for highly soluble salts 11 SOFT GELATIN CAPSULES CHEE 440 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 12 Soft Capsules fill material liquids are limited to those which do not affect capsule shell » water-immiscible vegetable oils, mineral oil, triglycerides » water-miscible, nonvolatile CHEE 440 PEG 400 and 600 must flow under gravity at 35 C or less shell provides a good barrier to oxygen and contains little residual water (7-10%) 13 Manufacture CHEE 440 14 Bioavailability CHEE 440 rapid absorption, typically as good as liquids better than tablets 15 Soft Capsules ADVANTAGES DISADVANTAGES CHEE 440 may contain liquids, suspensions, pastes rapid release of contents useful for drugs prone to oxidation have a greater tendency to adhere to each other more expensive increased possibility of interactions between drug and shell 16
