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US 2011/0218228 A1Published application
Crystalline sodium atorvastatin
AssigneeArrow International, Inc.
InventorsKailan Zhou, Hong Liu, Zhirong Chen, Huabin Hong, Yang Sun, Yunde Wang, Jiangchun Pan
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Abstract
Crystalline sodium atorvastatin, compositions containing the same and methods for the production thereof.
Claims9
1-55. (canceled)
A method for the preparation of crystalline sodium atorvastatin, the method comprising:
- (a) adding amorphous sodium atorvastatin to a first organic solvent to form a first solution;
- (b) adding a second organic solvent to the first solution to form a second solution;
- (c) allowing sodium atorvastatin to crystallize out from the solution;
- and
- (d) collecting the crystallized sodium atorvastatin, wherein the first organic solvent is ethanol and wherein the second organic solvent is butanone thereby obtaining crystalline sodium atorvastatin which exhibits an X-ray diffraction pattern comprising peaks expressed in degrees two-theta at approximately 3.67±0.2, 5.05±0.2, 6.85±0.2, 7.18±0.2, 8.33±0.2, 8.62±0.2, 9.38±0.2, 10.02±0.2, 10.35±0.2, 10.71±0.2, 11.76±0.2, 12.66±0.2, 13.87±0.2, 16.01±0.2, 16.38±0.2, 17.1±0.2, 19.1±0.2, 19.42±0.2, 20.88±0.2, 21.16±0.2, 22.9±0.2, 23.6±0.2, 30.12±0.2, 33.12±0.2, 37.92±0.2 and 41.47±0.2.
2 more elements
A pharmaceutical composition comprising amorphous sodium atorvastatin wherein the amorphous sodium atorvastatin is made by a method comprising:
- (i) preparing a first solution comprising sodium atorvastatin;
- (ii) adjusting the pH of the first solution to between about 1 and 4;
- (iii) adding an organic solvent to form a second solution;
- (iv) isolating an organic layer;
- (v) adjusting the pH of the organic layer to between about 9 and 10;
- and
- (vi) collecting precipitated amorphous sodium atorvastatin, wherein the first solution comprises about 5% sodium atorvastatin and the organic solvent is dichloromethane.
4 more elements
Dependencies are inferred from the claim text.