Patent ID: 8987448
Filing Date: 2015-03-24
Classification: A61P,C07D

Abstract:
1. A method of making Form B, a monohydrate crystalline form of a lactic acid salt of a compound of formula I, comprising: heating to a temperature ranging from 50 to 70° C. a suspension of the free base of the compound of formula I or a polymorphic form or a mixture of polymorphs of the lactic acid salt of compound of formula I and lactic acid in a solution comprising at least two solvents and a water activity of about 0.3 to about 0.6; and, isolating crystals of at least 90% pure form B from the solution at a temperature ranging from 50 to 60° C., wherein the CuKα XRPD pattern for the Form B has 2Θ peaks at 7.6°, 11.8°, 12.8°, 15.3°, 16.1°, 17.5°, 18.4°, 19.24°, 23.2°, 23.4°, 25.9°, 28.0°, 29.2° and 29.8°±0.2°, respectively.