Compositions and methods for treating bile acid malabsorption
AssigneeCosmo Technologies Limited
InventorsLuigi Maria LONGO, Stefania PAGANI
Life of this patent
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Abstract
Pharmaceutical compositions comprising bile acid sequestrants, their use in treating bile acid malabsorption, and associated conditions such as bile acid diarrhea and colitis are described herein. Methods for treating bile acid malabsorption and associated conditions are also described.
Claims32
A unit dose pharmaceutical composition for oral administration comprising a tablet core and a gastro-resistant coating covering the core,
- wherein the tablet core comprises a granulate component and a non-granulate component:
- wherein the granulate component comprises colesevelam, a pharmaceutically acceptable salt thereof, or a combination thereof, a diluent and a binder;
- wherein the non-granulate component comprises colesevelam or a pharmaceutically acceptable salt thereof and one or more of:
- a diluent, a disintegrant, a glidant and a lubricant;
- wherein the colesevelam, and/or the pharmaceutically acceptable salt thereof, or a combination thereof is present in an amount of at least about 66 wt % to about 90 wt % of the tablet core.
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A method of manufacturing a unit dose pharmaceutical composition for oral administration comprising the steps of:
- (a) providing a tablet core wherein the tablet core comprises:
- 1. a granulate component and a non-granulate component,
- 2. wherein the granulate component comprises colesevelam and/or a pharmaceutically acceptable salt thereof, a diluent and a binder,
- 3. wherein the non-granulate component comprises colesevelam or a pharmaceutically acceptable salt thereof, and optionally, one or more of a diluent, a disintegrant, a glidant and a lubricant, and
- 4. wherein the colesevelam and/or the pharmaceutically acceptable thereof is present in an amount of at least about 66 wt % to about 90 wt % of the tablet core, or at least about 70 wt % to about 90 wt % of the tablet core;
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- (b) coating the tablet core with a gastro resistant coating and optionally a sub-coating.
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Dependencies are inferred from the claim text.