Stable micronized candesartan cilexetil and methods for...

C - Chemistry – Metallurgy – 07 – D

Patent

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C07D 403/10 (2006.01) A61K 31/4184 (2006.01) A61P 9/10 (2006.01)

Patent

CA 2599415

The invention encompasses sable candesartan cilexetil of fine particle size, wherein desethyl-candesartan (desethyl-CNS) within the stable candesartan cilexetil does not increase to more than about 0.1%w/w by HPLC relative to the initial amount of candesartan cilexetil, when the stable candesartan cilexetil is maintained at a temperature of about 550~C for at least 2 weeks, methods of making the same and pharmaceutical compositions thereof.

L'invention porte sur un candésartan cilexetil stable de fine granulométrie, dans lequel le déséthyl-candésartan (déséthyl-CNS) dans le candésartan cilexetil stable n'augmente pas plus d'environ 0,1 % p/p par CLHP par rapport à la quantité initiale de candésartan cilexetil lorsque le candésartan cilexetil stable est maintenu à une température d'environ 550 °C pendant au moins 2 semaines. L'invention porte également sur des procédés de fabrication du candésartan cilexetil et de ses compositions pharmaceutiques.

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