Patent ID: 6750353
Filing Date: 2004-06-15
Classification: A61P,C07D,Y02P

Abstract:
A process for preparing a pharmaceutically acceptable atorvastatin salt in non-crystalline form, which comprises:a) providing a solution in a non-hydroxylic solvent of a compound of formula (I) â€ƒwhere A denotes a common protecting group or separate protecting groups for the two hydroxy groups, and B denotes a carboxylic acid protecting group; b) deprotecting the two hydroxy groups; c) deprotecting the carboxylic acid group; where steps b) and c) may be performed in either order; d) optionally concentrating the solution to not more than half its initial volume; e) adding water to the optionally concentrated solution; f) adding a solvent which is slightly miscible or immiscible with water and in which the pharmaceutically acceptable atorvastatin salt is insoluble or practically insoluble, in an amount not less than the water volume added in step e); g) optionally mixing the phases, and then separating the two phases; h) neutralizing the aqueous phase; i) converting atorvastatin in the aqueous phase to the pharmaceutically acceptable salt; and j) precipitating the pharmaceutically acceptable atorvastatin salt in non-crystalline form.