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US 2021/0228561 A1Published application
Compositions and methods for treating schizophrenia
AssigneeMinerva Neurosciences, Inc.
InventorsRemy LUTHRINGER, Nadine NOEL, Sandra WERNER
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Abstract
The disclosure provides a novel polymorph of Compound (I): 2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I).HCl.2H2O. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2H2O and related methods of treatment are also disclosed.
Claims18
A crystalline form of Compound (I);
- comprising a polymorph form (A) of Compound (I).HCl.2H2O, and wherein the form (A) has a X-ray powder diffraction pattern with at least one major peak substantially similar to at least one major peak shown in FIG. 11.
-8. (canceled)
A pharmaceutical formulation comprising Compound (I);
- wherein the formulation comprises a release modifier that provides a maximum plasma concentration (Cmax) of Compound (I) or the polymorph form (A) of Compound (I).HCl.2H2O below 50 ng/mL when a dose of between about 1-100 mg of the formulation is administered to a human.
-27. (canceled)
-37. (canceled)
Dependencies are inferred from the claim text.