| 摘要 |
1. A bioadhesive pharmaceutical composition comprising a pharmaceutically effective amount of an active ingredient, from 80 % to 98.8 % (w/w) pre-gelatinized starch, and from 1 % to 10 % (w/w) of a hydrophilic matrix forming polymer, characterized in that the composition further comprises from 0.2 % to 5 % (w/w) alkali C16-C22 alkyl fumarate as a lubricant. 2. A composition according to claim 1 wherein the lubricant is micronized sodium stearyl fumarate. 3. A composition according to claim 1 comprising from 2.5 to 7.5 % (w/w) of a hydrophilic matrix forming polymer. 4. A composition according to claim 3 wherein the polymer is polyacrylic acid (carbomer), hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, polyvinyl alcohol or a mixture thereof. 5. A composition according to claim 1 further comprising a glidant. 6. A composition according to claim 5 wherein the glidant is colloidal anhydrous silica. 7. A composition according to claim 1 comprising by weight based on the total weight: from 0.001 % to 10 % active ingredient; from 80 % to 99.8 % pre-gelatinized starch; from 1 % to 10 % hydrophilic matrix forming polymer; from 0.2 % to 5 % sodium stearyl fumarate; and from 0 % to 1 % glidant. 8. A dosage form suitable for oral, nasal, rectal or vaginal administration whic h comprises a composition as claimed in any one of claims 1 to 7 and which is shaped as a tablet. 9. A buccal tablet according to claim 8 comprising by weight based on the total weight of the tablet: 10 % microfine miconazole nitrate; 82.8 % drum dried waxy maize starch; 2 % sodium stearyl fumarate; 5 % carbomer 974 P; and 0.2 % colloidal anhydrous silica. 10. A buccal tablet according to claim 8 comprising by weight based on the total weight of the tablet: 1 % microfine triamcinolone; 91.8 % drum dried waxy maize starch; 2 % sodium stearyl fumarate; 5 % carbomer 974 P; and 0.2 % colloidal anhydrous silica. 11. A dry process for preparing tablets or capsules comprising the steps of: - intimately mixing the active ingredient, the pre-gelatinized starch and the hydrophilic matrix forming polymer in the dry state; - compacting the thus obtained mixture into a sheet; - breaking the sheet into a granulate; - blending the granulate with the lubricant and optionally the glidant; and - compressing the blend into tablets. 12. Products obtainable by the process according to claim 11. |
