Solid and crystalline dutasteride and processes for...

C - Chemistry – Metallurgy – 07 – J

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C07J 73/00 (2006.01)

Patent

CA 2709971

The present invention relates to a synthetic process for manufacturing Dutasteride comprising the mixed anhydride formation, subsequent reaction with 2,5- bis(trifluoromethyl)phenylamine in the presence of an appropriate Lewis catalyst and its isolation, purification and crystallization from acetonitrile/water. The invention also relates to a novel polymorphic form of Dutasteride, called form III, and a pharmaceutical composition comprising it.

L'invention concerne un procédé de synthèse pour la fabrication de dutastéride comprenant la formation d'anhydride mixte, la réaction ultérieure avec de la 2,5-bis(trifluorométhyl)phénylamine en présence d'un catalyseur de Lewis approprié et son isolation, sa purification et sa cristallisation à partir d'acétonitrile/d'eau. L'invention concerne également une nouvelle forme polymorphe de dutastéride, appelée forme III, et une composition pharmaceutique comprenant celle-ci.

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