Rosiglitazone hydrochloride hemihydrate

Details Rosiglitazone hydrochloride hemihydrate Rosiglitazone hydrochloride hemihydrate

C - Chemistry, Metallurgy

07

D

C07D 417/12 (2006.01) A61K 31/427 (2006.01) A61P 3/10 (2006.01)

Patent

CA 2646627

5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione, hydrochloride hemihydrate (rosiglitazone hydrochloride hemihydrate) characterized in that: (i) comprises water in the range of from 1.0 to 2.5% w/w; and (ii) provides an infrared spectrum containing peaks at about 3504, 2751, 1688, 1601 and 1215 cm-1 ; and/or (iii) provides an X-ray powder diffraction (XRPD) pattern containing peaks at about 12.5, 17.1, 21.3, 26.7, 27.7 °2 .theta.; a process for preparing such a compound, a pharmaceutical composition containing such a compound and the use of such a compound in the treatment and/or prophylaxis of diabetes mellitus.

La présente invention concerne la 5-[4-[2-(N-méthyl-N-(2-pyridyl)amino)éthoxy]benzyl]thiazolidine-2,4-dione, chlorhydrate hémihydraté (chlorhydrate de rosiglitazone hémihydraté), caractérisée en ce que : (i) sa teneur en eau varie de 1,0 à 2,5 % (poids/poids) ; et (ii) son spectre infrarouge présente des pics d'environ 3504, 2751, 1688, 1601 et 1215 cm-1 ; et/ou (iii) son spectre de diffraction des rayons X sur poudre (XRPD) présente des pics d'environ 12,5, 17,1, 21,3, 26,7, 27,7 °2 .theta. ; l'invention concerne également un procédé permettant de préparer un tel composé, une composition pharmaceutique contenant un tel composé et l'utilisation de ce composé pour le traitement et/ou la prophylaxie du diabète sucré.

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