Process for annealing amorphous atorvastatin
AssigneePfizer Inc.
InventorsRenuka Devi Reddy, Evgenyi Shalaev, Ravi Mysore Shanker, Carl Bernard Ziegler
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Abstract
Processes for annealing amorphous atorvastatin is described. Pharmaceutical compositions and formulations containing annealed amorphous atorvastatin are also described.
Claims10
A process for annealing amorphous atorvastatin admixed with a pharmaceutically acceptable diluent, carrier, or excipient at elevated temperature comprising heating at ambient pressure amorphous atorvastatin in an essentially solvent-free system wherein no additional solvent is added to a temperature of between approximately 50° C. to approximately 140° C.;
- holding said temperature for approximately 30 minutes to approximately 12 hours;
- and cooling the resulting annealed amorphous atorvastatin.
A process for annealing amorphous atorvastatin at elevated or high pressure comprising treating amorphous atorvastatin in an essentially solvent-free system wherein no additional solvent is added at a pressure of between approximately 0.1 kBar to approximately 250 kBar at a temperature of between ambient temperature to approximately 150° C. for approximately 1 minute to approximately 30 days.
Dependencies are inferred from the claim text.