Claims for Patent: 6,099,863
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Summary for Patent: 6,099,863
| Title: | Fast-dissolving galanthamine hydrobromide tablet |
| Abstract: | The present invention is concerned with a fast-dissolving tablet for oral administration comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, characterized in that said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and a disintegrant; and with a direct compression process of preparing such fast-dissolving tablets. |
| Inventor(s): | Gilis; Paul Marie Victor (Beerse, BE), De Conde; Valentin Florent Victor (Lommel, BE) |
| Assignee: | Janssen Pharmaceutica N.V. (Beerse, BE) |
| Application Number: | 09/202,187 |
| Patent Claims: |
1. A tablet comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, wherein said
carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and an insoluble or poorly soluble cross-linked polymer disintegrant.
2. A tablet according to claim 1 wherein the disintegrant is crospolyvidone or croscarmellose. 3. A tablet according to claim 1 wherein the carrier further comprises a glidant and a lubricant. 4. A tablet according to claim 3 wherein the glidant is colloidal anhydrous silica and wherein the lubricant is magnesium stearate. 5. A tablet according to claim 1 comprising by weight based on the total weight: (a) from 2 to 10% galanthamine hydrobromide (1:1); (b) from 83 to 93% spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25); (c) from 0.1 to 0.4% glidant; (d) from 3 to 8% insoluble crosslinked polymeric disintegrant; and (e) from 0.2 to 1% lubricant. 6. A tablet according to claim 5 comprising (a) about 2 to 10% galanthamine hydrobromide (1:1); (b) about 83 to 93% spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25); (c) about 0.2% colloidal anhydrous silica; (d) about 5% crospolyvidone; and (e) about 0.5% magnesium stearate. 7. A tablet according to claim 1 which is film-coated. 8. A tablet according to claim 7 wherein the film-coat comprises a film-forming polymer and a plasticizer. 9. A tablet according to claim 8 wherein the film-coat weighs from about 3% to about 8% of the uncoated tablet core. 10. A process of preparing a tablet according to claim 3 comprising the steps of: (i) dry blending the active ingredient, the disintegrant and the optional glidant with the diluent; (ii) optionally mixing the lubricant with the mixture obtained in step (i); (iii) compressing the mixture obtained in step (i) or in step (ii) in the dry state into a tablet; and (iv) optionally film-coating the tablet obtained in step (iii). |
