Process and composition using ondansetron
AssigneeGlaxo Group Limited
InventorDavid T. Collin
Life of this patent
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Abstract
The invention relates to a process for reducing the crystal size of ondansetron hydrochloride dihydrate produced by crystallisation from solvent to a size which is suitable for effective distribution in a tablet blend, in particular 100% less that 250 .mu.m. The ondansetron hydrochloride dihydrate is desolvated by drying at elevated temperature and reduced or atmospheric pressure and is then rehydrated.
Claims10
A process for reducing the crystal size of ondansetron hydrochloride dihydrate produced by crystallisation from solvent, in which said ondansetron hydrochloride dihydrate is desolvated by drying at elevated temperature and reduced or atmospheric pressure and is then rehydrated, wherein the resulting crystals are suitable for homogeneous distribution in a tablet blend, and wherein 100% of the resulting crystals have a size of less than 250 .mu.m and at least about 80% by weight of the crystals have a size of less than 63 .mu.m.
Crystalline ondansetron hydrochloride dihydrate in which 100% of the crystals have a size of less than 250 .mu.m and at least about 80% by weight of the crystals have a size of less than 63 .mu.m.
A pharmaceutical composition in the form of tablets containing crystalline ondansetron hydrochloride dihydrate as active ingredient, in which 100% of said ondansetron hydrochloride dihydrate crystals have a size less than 250 .mu.m and at least about 80% by weight of said crystals have a size less than 63 .mu.m.
Dependencies are inferred from the claim text.