Stable dosage forms of levomilnacipran
AssigneeForest Laboratories Holdings Limited
InventorsAnil Chhettry, Murali Divi, Rahul Surana
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Abstract
The present invention relates to stable dosage forms of levomilnacipran and pharmaceutically acceptable salts thereof. Processes for the preparation of these dosage forms and methods of using these dosage forms are also described.
Claims23
A stable dosage form comprising levomilnacipran or a pharmaceutically acceptable salt thereof.
A stable dosage form comprising an active ingredient that comprises at least 98% by weight of levomilnacipran or pharmaceutically acceptable salt thereof.
A stable dosage form comprising an active ingredient that comprises substantially pure levomilnacipran or pharmaceutically acceptable salt thereof, and about 0.01% to about 0.2% by weight of (1S,5R)1-phenyl-3-azabicyclo[3-1-0]hexane-2-one, wherein the dosage form comprises an X-ray powder diffraction (XRD) pattern that comprises characteristic peaks at 12.0, 20.1 and 22.5±0.2 degrees 2Ø.
Dependencies are inferred from the claim text.