Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2011-08-09
2011-08-09
Wilson, James O (Department: 1624)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C544S336000
Reexamination Certificate
active
07994178
ABSTRACT:
The present invention provides a crystalline form of rosuvastatin calcium characterized by an X-ray powder diffraction pattern having peaks at about 4.7, 19.4 and 22.3° 2θ±0.2° 2θ. The crystalline form of the invention may be further characterized by a DSC thermogram with an endotherm at about 132° C. and another broad endotherm at about 220° C. to about 240° C., and a TGA thermogram showing a weight loss of about of 3 to about 5 percent up to about 100° C. The invention also provides a pharmaceutical composition comprising the crystalline rosuvastatin calcium, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient.
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Niddam-Hildesheim Valerie
Shabat Shalom
Wizel Shlomit
Kenyon & Kenyon LLP
Teva Pharmaceutical Industries Ltd.
Willis Douglas M
Wilson James O
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