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 with a solubilizing agent selected from a group consisting of: a polyoxyethylene fatty acid ester and a cyclodextrin; and
(b) lyophilizing the solution to afford said amorphous atorvastatin.
2. The process of claim 1 wherein the solubilizing agent is selected from the group consisting of polysorbate 80 and a cyclodextrin.
3. The process of claim 2 wherein the cyclodextrin is beta-cyclodextrin.