Polymorphic forms of asenapine maleate and processes for their preparation

摘要

Are disclosed new crystalline forms of asenapine maleate, useful in the production of pharmaceutical formulations for the treatment of diseases of the central nervous system, in particular schizophrenia; processes for the production of these new crystalline forms are also disclosed.

主权项

1. Anhydrous crystalline form of asenapine maleate characterized by an XRPD pattern comprising peaks at 10.1°, 10.7°, 12.1°, 17.1°, 20.0°, 22.4°, and 24.4° 2θ, each angle value having an approximation of ±0.2° 2θ, and a DSC thermogram, obtained at a scanning rate of 10° C./min under inert atmosphere, showing an intense endothermic feature between 112.8 and 144.2° C., each temperature value having an approximation of ±0.5° C.