Patent ID: 6992194
Filing Date: 2006-01-31
Classification: A61K,A61P,C07D

Abstract:
1. A process for preparing the crystalline atorvastatin hemi-calcium and solvates thereof characterized by a physical or spectroscopic analysis result selected from the group consisting of: a) a powder X-ray diffraction pattern generated using CuK b) a powder X-ray diffraction pattern generated using CuK c) d-spacings of about 30.81, 18.46, 16.96, 15.39, 14.90, 12.78, 11.05, 9.58, 9.22, 7.42, 6.15, 5.43, 4.62, 4.44, and 3.98 Å; d) a monoclinic unit cell with cell parameters: a=18.55-18.7 Å, b=5.52-5.53 Å, c=31.0-31.2 Å and β=97.5-99.5 e) a solid state cross-polarization/magic angle spinning f) a solid state cross-polarization/magic angle spinning the process comprising the steps of: (i) suspending any other crystalline or amorphous form of atorvastatin hemi-calcium in a diluent selected from the group consisting of lower alcohols and mixtures of lower alcohols and water for a period of time sufficient to cause substantial conversion to the crystalline atorvastatin hemi-calcium characterized by a physical or spectroscopic analysis result selected from the group consisting of a), b), c), d), e) and f), or a solvate thereof, and (ii) separating the diluent.