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US 8,911,787 B2Granted
Stable oral benzimidazole compositions and process of preparation thereof
AssigneeRanbaxy Laboratories Limited
InventorsRajesh Gandhi, Chayapathy Issa, Vishnubhotla Nagaprasad
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Abstract
The present invention relates to stable oral compositions of one or more benzimidazole compounds and processes for their preparation. Also provided are methods for treating various gastrointestinal disorders.
Claims16
A stable oral benzimidazole composition comprising;
- a) a benzimidazole core in the form of bead, the core comprising a pharmaceutically acceptable inert carrier coated with amorphous esomeprazole magnesium and one or more pharmaceutically acceptable additives;
- b) a separating layer surrounding the core;
- and
- c) an enteric coating surrounding the separating layer,
- wherein the composition contains less than about 30% by weight of crystalline esomeprazole magnesium after storage at 40° C. and 75% relative humidity for 3 months.
2 more elements
A stable oral benzimidazole composition prepared according to a process, which process comprises the steps of
- a) preparing a benzimidazole core formed by dispersing amorphous esomeprazole magnesium and one or more pharmaceutically acceptable additives in an aqueous or hydroalcoholic medium to obtain a dispersion;
- b) spraying the dispersion on to a pharmaceutically acceptable inert carrier;
- c) coating the core with a separating layer;
- and
- d) coating the product of step (b) with an enteric coating, wherein the composition contains less than about 30% by weight of crystalline esomeprazole magnesium after storage at 40° C. and 75% relative humidity for 3 months.
2 more elements
A stable oral benzimidazole composition prepared according to a process, which process comprises the steps of
- a) preparing a benzimidazole core formed by dispersing amorphous esomeprazole magnesium and one or more pharmaceutically acceptable additives in an aqueous or hydroalcoholic medium to obtain a dispersion;
- b) spraying the dispersion on to a pharmaceutically acceptable inert carrier:
- c) coating the core with a separating layer;
- and
- d) coating the product of step (b) with an enteric coating,
- wherein said composition contains less than about 5% by weight of crystalline esomeprazole magnesium after storage at 40° C. and 75% relative humidity for 3 months.
3 more elements
A stable oral benzimidazole composition comprising;
- a) a benzimidazole core in the form of bead, the core comprising a pharmaceutically acceptable inert carrier coated with one or more amorphous benzimidazole compounds and one or more pharmaceutically acceptable additives, wherein during coating of the core a dispersion of the one or more amorphous benzimidazole compounds and the one or more pharmaceutically acceptable additives in an aqueous or hydroalcoholic medium was applied onto the pharmaceutically acceptable inert carrier at a bed temperature of less than about 50° C. for a total spraying time of less than about 24 hours;
- b) a separating layer surrounding the core;
- and
- c) an enteric coating surrounding the separating layer,
- wherein the composition contains less than about 30% by weight of crystalline benzimidazole, after storage at 40° C. and 75% relative humidity for 3 months.
2 more elements
Dependencies are inferred from the claim text.