A novel process for preparation of substantially pure...

C - Chemistry – Metallurgy – 07 – D

Patent

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Details

C07D 207/38 (2006.01) A61K 31/4015 (2006.01) A61P 3/10 (2006.01)

Patent

CA 2582230

The present invention discloses a novel process for purification of trans-4- methyl cyclohexylamine HC1 and 4-[2-(3-Ethyl-4-methyl-2-carbonyl pyrrolidine amido) ethyl] benzene sulfonamide used in the synthesis of 3-Ethyl-2,5-dihydro- 4-methyl-N-[2-[4-[[[[(trans-4-methyl cyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1- carboxamide(I), popularly known as Glimepiride. The present invention also discloses a novel purification of Glimepiride Form I (I), having the undesired cis isomer below 0.15%. Glimepiride (I) is useful in the treatment of diabetes mellitus.

L~invention concerne un nouveau procédé de purification de trans-4-méthylcyclohexylamine HC1 et de 4-[2-(3-éthyl-4-méthyl-2-carbonylpyrrolidinamido)éthyl]benzènesulfonamide utilisés dans la synthèse de 3-éthyl-2,5-dihydro-4-méthyl-N-[2-[4-[[[[(trans-4-méthylcyclohexyl)amino]carbonyl]amino]sulfonyl]phényl]éthyl]-2-oxo-1H-pyrrole-1-carboxamide (I), populairement connu sous le nom de Glimépiride. L~invention concerne également un nouveau procédé de purification de Glimépiride de forme I (I), ayant moins de 0,15% de l~isomère cis indésirable. Le Glymépiride (I) est utile pour le traitement du diabète mellitus.

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