Process for preparing ondansetron hydrochloride dihydrate having a defined particle size
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United States of America Patent
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Oct 30, 2007
Grant Date -
Nov 24, 2005
app pub date -
May 5, 2005
filing date -
May 7, 2004
priority date (Note) -
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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 .mu.m, 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.degree. C. or less.
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