Pharmaceutical composition comprising crystalline...

C - Chemistry – Metallurgy – 07 – C

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C07C 309/04 (2006.01) A61K 31/135 (2006.01) A61K 31/185 (2006.01) C07C 211/29 (2006.01) C07C 303/00 (2006.01)

Patent

CA 2501321

The present invention relates to a pharmaceutical composition for treating or preventing obesity, comprising novel crystalline sibutramine methanesulfonate hemihydrate of formula (I). The crystalline sibutramine methanesulfonate hemihydrate according to the present invention has a much higher solubility in water, and enhanced stability under a high humidity/temperature condition, as compared with sibutramine hydrochloride monohydrate.

L'invention concerne une composition pharmaceutique de traitement ou de prévention de l'obésité, comprenant un nouvel hémihydrate de méthanesulfonate de sibutramine cristallin de formule (I). Ledit hémihydrate de méthanesulfonate de sibutramine cristallin de l'invention présente une hydrosolubilité supérieure ainsi qu'une stabilité accrue dans des conditions d'humidité/température élevées, par rapport au monohydrate d'hydrochlorure de sibutramine.

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