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Claims for Patent: 6,099,863

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Claims 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).
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