1. 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

2. 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

3. Hard Gelatin Capsules contain 12 - 16 % moisture typically filled with dry solids  powders  granules  pellets  tablets also contain  colorant  preservatives B. Amsden3CHEE 440

4. Manufacture B. Amsden4CHEE 440 http://www.rjengineering.com/process.htm

5. 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

6. 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

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

8. Bioavailability factors which influence bioavailability B. Amsden8CHEE 440

9. 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

10. 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

11. Manufacture B. Amsden11CHEE 440

12. Bioavailability B. Amsden12CHEE 440

13. 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