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|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)|
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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