Patent ID: 9056846
Filing Date: 2015-06-16
Classification: A61K,A61P,C07D

Abstract:
1. A method of treating a condition selected from the group consisting of schizophrenia, bipolar disorder, acute mania, and depression, the method comprising administering to a patient in need thereof a solid oral pharmaceutical formulation comprising from about 0.05 to about 9 mg trans-1{4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and an excipient having low water activity selected from the group consisting of pregelatinized starch, mannitol, anhydrous calcium hydrogen phosphate, and mixtures thereof, wherein the formulation provides an in vivo plasma profile comprising a mean C max of less than about 26.3 ng/mL, a mean AUC 0 -∞ of more than about 2 ng·hr/mL and a mean T max of about 3 or more hours, wherein the formulation has a dissolution rate of more than about 80% within about the first 60 minutes following administration of the composition to the patient; and wherein the formulation has a pH in the range of about 9.0 to about 12.0.