CHEE 4401 CAPSULES u solid dosage form u the drug is enclosed within either a hard or soft shell ä shell is typically made of gelatin u primarily intended for oral delivery u provide a rapid release of contents

CHEE 4402 Gelatin u protein, prepared from hydrolysis of collagen (animal bones and skin) ä type A : pI = 7-9, pig skin ä type B : pI = 5, animal bones u possesses 4 essential properties u stable when dry u subject to microbial degradation when moist u digested and absorbed

CHEE 4403 Hard Gelatin Capsules u contain % moisture u typically filled with dry solids ä powders ä granules ä pellets ä tablets u contain ä colorant ä preservatives

CHEE 4404 u come in 2 sections - body and cap u may be colored u may have a tamper-proof band u can be self-locking (ex. Coni-Snap) u come in varying sizes Hard Gelatin Capsules

CHEE 4405 Manufacture

6 Filling u operations involved ä rectification of empty capsules ä separation of caps from bodies ä filling capsule bodies ä replacing caps and ejecting filled capsules u 3 basic methods for powder filling ä auger or screw ä dosator ä dosing disc

CHEE 4407 Capsule Filling ä auger »semi-automatic operation »filling based on volume »need good powder flow ä dosator »fill based on weight »continuous operation

CHEE 4408 Capsule Filling ä dosing disc »filled based on weight »continuous operation

CHEE 4409 Bioavailability u factors which influence bioavailability ä disintegration rate »at body T, gelatin dissolves ä drug particle size

CHEE Factors Influencing Bioavailability ä concentration of lubricants and glidants ä packing density of powder

CHEE Hard Gelatin Capsules u Advantages ä tasteless and odorless ä swallowing is easy ä flexibility in formulating ä uniquely suitable for blinded clinical trials ä useful for extemporaneous compounding by pharmacist u Disadvantages ä tend to be more expensive to produce than tablets ä not suitable for highly soluble salts

CHEE SOFT GELATIN CAPSULES u consist of a continuous gelatin shell surrounding a liquid core u formed, filled, and sealed in one operation u shells are softened by addition of glycerin or polyhydric alcohol (ex. sorbitol) u oblong, spherical, elliptical in shape

CHEE Soft Capsules u fill material ä liquids are limited to those which do not affect capsule shell »water-immiscible u vegetable oils, mineral oil, triglycerides »water-miscible, nonvolatile u PEG 400 and 600 ä must flow under gravity at 35 C or less u shell provides a good barrier to oxygen and contains little residual water (7-10%)

CHEE Manufacture

CHEE Bioavailability ä rapid absorption, typically as good as liquids ä better than tablets

CHEE Soft Capsules u ADVANTAGES ä may contain liquids, suspensions, pastes ä rapid release of contents ä useful for drugs prone to oxidation u DISADVANTAGES ä have a greater tendency to adhere to each other ä more expensive ä increased possibility of interactions between drug and shell