Process for preparing ondansetron hydrochloride dihydrate...

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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Reexamination Certificate

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11122401

ABSTRACT:
The invention provides a process for preparing ondansetron hydrochloride dihydrate particles in which at least about 70% of the particles have a particle size of less than 250 μm, comprising the steps of:(a) preparing a solution comprising ondansetron hydrochloride and water; and(b) adding the solution into a precipitation medium which comprises a water-miscible nonsolvent for ondansetron hydrochloride, while maintaining the resulting mixture at a temperature of about 40° C. or less.

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