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Claims for Patent: 8,022,228

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Claims for Patent: 8,022,228

Title:Crystal form of asenapine maleate
Abstract: The invention relates to an orthorhombic crystal form of compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- ,5-c]pyrrole(Z)-2-butenedioate, to methods for the preparation of this crystal form and to pharmaceutical compositions comprising an orthorhombic crystal form.
Inventor(s): Heeres; Gerhardus Johannes (Oss, NL)
Assignee: N.V. Organon (Oss, NL)
Application Number:11/939,023
Patent Claims: 1. The compound trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- ,5-c]pyrrole(Z)-2-butenedioate, wherein the compound is in a microcrystalline orthorhombic crystal form.

2. The microcrystalline form of the compound according to claim 1 which has a particle size distribution yielding a d95 value less than or equal to about 100 microns.

3. The microcrystalline form of the compound according to claim 2 which yields an X-ray powder diffraction pattern obtained with CuK.alpha. (radiation having peaks at values of 2-theta (20) of 10.5.degree. and 15.7.degree..

4. The compound according to claim 1 which is characterized by an X-ray powder diffraction pattern obtained with CuK.alpha. radiation with peaks at values of 2-theta (2.theta.) of 10.5.degree., 15.7.degree., 18.3.degree., 19.0.degree., 22.2.degree., 23.2.degree. and 27.5.degree..

5. A process for preparing an orthorhombic microcrystalline form trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- -5,c]pyrrole(Z)-2-butenedioate, wherein the orthorhombic microcrystalline form of the compound is at least about 90 wt. % of compound, the process comprising crystallizing the compound from an ethanol/water mixture which is in a 9:1 volume proportion and micronizing said crystalline material thus obtained.

6. The microcrystalline form of the compound according to claim 2 which has a particle size distribution yielding a d95 value of less than or equal to about 50 microns.

7. The microcrystalline form of the compound according to claim 2 which has a particle size distribution yielding a d95 value of less than or equal to about 30 microns.
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