Patent ID: 7342120
Filing Date: 2008-03-11
Classification: A61K,A61P,C07D

Abstract:
1. A process for preparing atorvastatin hemi-calcium Form II comprising the steps of: a) suspending [R—(R*,R*)]-2-(4-fluorophenyl)-β,δ-dioxane-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-tert-butylheptanoic ester in methanol, b) deprotecting the [R—(R*,R*)]-2-(4-fluorophenyl)-β,δ-dioxane-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-tert-butylheptanoic ester by adding hydrochloric acid to the suspension, thereby forming a solution of atorvastatin ester derivatives in methanol, c) adding calcium hydroxide to the solution, thereby forming a solution of atorvastatin hemi-calcium in methanol, d) optionally removing any excess calcium hydroxide, and e) precipitating atorvastatin hemi-calcium from the solution as Form II; where Form II is characterized by having a powder X-ray diffraction pattern with peaks at 8.5, 9.0, 17.0, and 20.5±0.2 degrees 2θ.