Atorvastatin calcium propylene glycol solvates
AssigneeApotex Pharmachem Inc.
InventorsK.S. Keshava Murthy, Yajun Zhao, Allan W. Rey, Daqing Che, David A. Stradiotto, Uma Kotipalli
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Abstract
Atorvastatin calcium propylene glycol solvates and processes to prepare these novel solvates which are particularly useful and suitable for pharmaceutical applications.
Claims22
Atorvastatin calcium propylene glycol solvate.
Atorvastatin calcium propylene glycol solvate having a DSC endotherm with a peak onset temperature of about 183° C. and a peak maximum of about 192° C.
Atorvastatin calcium propylene glycol solvate having a DSC thermogram as shown in FIG. 1 of the description.
Atorvastatin calcium propylene glycol solvate characterized by an IR spectrum (1% KBr) having characteristic peaks at about 3382, 1652, 1510, 1436, 1315, 1221, and 844 cm−1.
Atorvastatin calcium propylene glycol solvate having an IR spectrum as shown in FIG. 2 of the description.
A process for preparing atorvastatin calcium propylene glycol solvate comprising the steps of:
- (a) adding atorvastatin calcium to propylene glycol;
- (b) adding an organic co-solvent;
- (c) optionally adding water, and
- (d) isolating and optionally drying the isolated solvate by filtration.
A process for the purification of atorvastatin calcium by formation of propylene glycol solvates of atorvastatin calcium and thereafter desolvation of the atorvastatin calcium propylene glycol solvates and recovery of atorvastatin calcium.
A process for the preparation of atorvastatin calcium by desolvating atorvastatin calcium propylene glycol solvate to produce atorvastatin calcium and propylene glycol.
Dependencies are inferred from the claim text.