Process for forming amorphous atorvastatin
View Patent ↗A process for forming amorphous atorvastatin comprising the steps of dissolving atorvastatin in a non-hydroxylic solvent and removing the solvent by freeze-drying, as well as processes of dissolving atorvastatin in a hydroxylic solvent with a solubilizing agent or an alkalizing agent or an antioxidant and removing the solvent by freeze-drying to afford amorphous atorvastatin.
1. A process for forming amorphous atorvastatin comprising:
(a) dissolving atorvastatin in a water solvent containing an alkalizing agent selected from the group consisting of: an alkali metal salt; an alkali metal hydroxide; and alkaline earth metal salt; an alkaline earth metal hydroxide; an amino acid; and a volatile base; and
(b) lyophilizing the solution to afford said amorphous atorvastatin.
2. The process of claim 1 wherein volatile base is selected from the group consisting of: ammonium hydroxide; a tetraalkylammonium hydroxide; a secondary amine; a tertiary amine; an aryl amine; and ammonium bicarbonate.
3. The process of claim 1 wherein the alkali metal hydroxide is sodium hydroxide.