Patent ID: 7994343
Filing Date: 2011-08-09
Classification: A61P,C07D

Abstract:
1. A process for the production of atorvastatin calcium in amorphous form comprising: a) reacting a solution of (4R-cis)-1,1-dimethylethyl-6-{2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)-carbonyl]-1H-pyrrol-1yl]ethyl}-2,2-dimethyl-1,3-dioxane-4-acetate (Compound H) in a water-miscible solvent with an acid to obtain [R—(R*,R*)]-1,1-dimethylethyl-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoate (Compound I); b) treating Compound I with an alkali metal hydroxide to obtain an alkali metal salt of atorvastatin; c) washing the solution of alkali metal salt of atorvastatin with a solvent immiscible or slightly miscible in water; d) treating the washed solution of alkali metal salt of atorvastatin with a calcium salt or calcium hydroxide to obtain atorvastatin calcium; e) isolating crude atorvastatin calcium; f) purifying crude atorvastatin calcium by dissolving in a mixture of tetrahydrofuran and methanol, and precipitating with water to obtain pure atorvastatin calcium in crystalline form; and g) converting crystalline pure atorvastatin calcium so obtained into amorphous form.