Novel polymorphic forms of metopimazine
AssigneeNeurogastrx, Inc.
InventorsShu Yu, Robert Wenslow
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Abstract
Provided herein are novel polymorphic forms of metopimazine mesylate. These polymorphic forms are useful in methods, compositions, and kits for the treatment of an enteric nervous system disorder.
Claims78
A crystalline form of metopimazine mesylate,
The crystalline form of any preceding claim, wherein the crystalline form comprises metopimazine mesylate Crystal Form A.
A crystalline form of metopimazine mesylate characterized by an X-ray powder diffraction (XRPD) pattern comprising two or more of the following 2θ values:
- 9.37°, 9.87°, 14.33°, 15.26°, 15.91°, 16.55°, 17.52°, 17.75°, 18.75°, 19.09°, 19.72°, 20.80°, 21.22°, 21.77°, 23.29°, 23.91°, 24.44°, 25.37°, 26.39°, 26.92°, 27.96°, 28.23°, 28.78°, 29.27°, 29.64°, 30.67°, 31.29°, 31.84°, 32.09°, 32.99°, 33.40°, 33.99°, 35.91°, 36.80°, 37.41°, 37.92°, and 39.27°±0.2°.
A crystalline form of metopimazine mesylate characterized by an XRPD pattern comprising one or more of the following 2θ values:
- 9.37°, 15.26°, 15.91°, 18.75°, 19.09°, 20.80°, 21.22°, 21.77°, and 24.44°±0.2°.
A crystalline form of metopimazine mesylate characterized by a 13C solid state Nuclear Magnetic Resonance (ssNMR) spectrum comprising at least one peak, expressed as chemical shift in ppm, selected from the following:
- 176.8, 176.4, 142.2, 141.7, 140.9, 140.0, 128.3, 127.0, 126.2, 125.1, 121.1, 119.9, 114.7, 110.9, 57.0, 55.7, 50.6, 47.1, 45.6, 42.1, 40.2, 27.4, and 21.3±0.20 ppm.
A crystalline form of metopimazine mesylate characterized by a differential scanning calorimetry pattern comprising a single endotherm comprising an onset temperature range of 208° C. to 212° C.
A crystalline form of metopimazine mesylate characterized by a thermogravimetric analysis profile comprising a total weight loss of 0.4% up to 150.0° C.
Dependencies are inferred from the claim text.