NEW CRYSTAL FORMS OF THE SALT OF TRANS-5-CHLORO-2-METHYL-2,3,3A,12b-TETRAHYDRO-1H-DIBENZO[2,3:6,7]OXEPINO[4,5-c]PYRROLE WITH MALEIC ACID

摘要

The present invention relates to two new crystal forms of the salt of trans-5-chloro-2- methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrolewith maleic acid, processes for preparing thereof and compositions comprising thereof. These new crystal forms of the salt of trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H- dibenzo[2,3:6,7]oxepino[4,5-c]pyrrolewith maleic acid are stable under micronization and show an improved water solubility when compared to other asenapine maleate crystalline forms described in the prior art, such as the orthorhombic form (form L) and the monoclinic form (form H).