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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 method of treating a disorder selected from dementia, mania or nicotine dependence in a patient in need thereof comprising administering to the patient 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. The method of claim 1 wherein the disorder is dementia.
3. The method of claim 2 wherein the disorder is Alzheimer's dementia.
4. The method of claim 1 wherein the disorder is mania.
5. The method of claim 1 wherein the disorder is nicotine dependence.
6. A fast-dissolving galanthamine hydrobromide (1:1) tablet made by (i) dry blending the active ingredient, an insoluble or poorly soluble cross-linked polymer disintegrant and an optional glidant with a diluent comprising a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25); (ii) optionally mixing a 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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