Crystalline forms of atorvastatin 4-(nitrooxy) butyl ester

Details Crystalline forms of atorvastatin 4-(nitrooxy) butyl ester Crystalline forms of atorvastatin 4-(nitrooxy) butyl ester

C - Chemistry, Metallurgy

07

D

C07D 207/34 (2006.01) A61K 31/40 (2006.01) A61P 25/00 (2006.01) A61P 37/00 (2006.01)

Patent

CA 2681596

The present invention relates to two crystalline forms designated as form A and form B, of (.beta.R, .delta.R) -2 (4-fluorophenyl) - .beta., .delta.-dihydroxy-5- (1-methylethyl) -3-phenyl-4- [ (phenylamino) carbon-yl] -1H-pyrrole-1-heptanoic acid 4- (nitrooxy) butyl ester (atorvastatin 4- (nitrooxy) butyl ester), represented by the formula (I), The invention also relates to processes for the preparation of the forms A and B, to pharmaceutical compositions comprising the two forms, and to their use for treating and/or preventing acute coronary syndromes, stroke, neurodegenerative disorders, such as Alzheimer's and Parkinson's disease as well as autoimmune diseases, such as multiple sclerosis.

La présente invention concerne deux formes cristallines, appelées forme A et forme B, de l'ester 4-(nitrooxy)butylique de l'acide (.beta.R, .delta.R)-2(4-fluorophényl)-.beta.,.delta.-dihydroxy-5-(1-méthyléthyl)-3-phényl-4-[(phénylamino)carbon-yl]-1H-pyrrole-1-heptanoïque, c'est-à-dire l'ester 4-(nitrooxy)butylique de l'atorvastatine, représenté par la formule (I). L'invention concerne également des procédés de préparation desdites formes A et B, des compositions pharmaceutiques comprenant lesdites formes, ainsi que leur utilisation pour traiter et/ou prévenir les syndromes coronaires aigus, les accidents vasculaires cérébraux, les troubles neurodégénératifs tels que les maladies d'Alzheimer et de Parkinson, ainsi que les maladies auto-immunes telles que la sclérose en plaques.

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