TOFACITINIB ORAL SUSTAINED RELEASE DOSAGE FORMS
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Abstract
The present invention relates to oral sustained release formulations of tofacitinib and pharmaceutical acceptable salts thereof. The formulations described herein have desirable pharmacokinetic characteristics.
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112 Claims
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1-104. -104. (canceled)
- 105. A method of treating immunological disorders in a subject comprising administering to the subject in need thereof a once daily pharmaceutical dosage form in an amount effective in treating such disorders, wherein the once daily pharmaceutical dosage form comprising tofacitinib, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein said dosage form is a sustained release dosage form, and when administered to a subject has a mean area under the plasma concentration versus time curve following administration from about 17 ng-hr/mL per mg of tofacitinib dosed to about 42 ng-hr/mL per mg of tofacitinib dosed and a ratio of geometric mean plasma Cmax to Cmin from about 10 to about 100.
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112-114. -114. (canceled)
Specification