Claims for Patent: 6,099,863

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).