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Last Updated: December 22, 2024

Claims for Patent: 7,741,358

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Summary for Patent: 7,741,358

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:	11/399,204
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,741,358
Patent Claims:	1. Orthorhombic trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- ,5-c]pyrrole (Z)-2-butenedioate isolated in a form which contains at least about 90 wt. % of the orthorhombic crystalline form. 2. 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.. 3. 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., 20.3.degree., 20.8.degree., 22.2.degree., 23.2.degree., 25.6.degree. and 27.5.degree.. 4. The compound according to claim 1 which is characterized by a Raman spectroscopic pattern with peaks at values of 3051 cm.sup.-1, 3029 cm.sup.-1, 3011 cm.sup.-1, 2888 cm.sup.-1, 824 cm.sup.-1 and 717 cm.sup.-1. 5. The compound according to claim 1 which is characterized by a Raman spectroscopic pattern with peaks at values of 3072 cm.sup.-1, 3051 cm.sup.-1, 3029 cm.sup.-1, 3011 cm.sup.-1, 2909 cm.sup.-1, 2888 cm.sup.-1, 1245 cm.sup.-1, 824 cm.sup.-1, 747 cm.sup.-1, 717 cm.sup.-1 and 194 cm.sup.-1. 6. A method of preparation of the compound according to claim 1 characterized in that trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7]oxepino[4,5-c]pyrrole (Z)-2-butenedioate is crystallized from an ethanol/water mixture. 7. A pharmaceutical composition comprising a pharmaceutically acceptable excipient and trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7]oxepino[4,5-c]pyrrole (Z)-2-butenedioate in the orthorhombic crystal form, wherein said composition is prepared by using the trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4- ,5-c]pyrrole (Z)-2-butenedioate of claim 1. 8. A method of treating a mental disorder selected from schizophrenia and bipolar disorder in a mammal, comprising administering a therapeutically effective amount of a composition of claim 7. 9. The method according to claim 8, wherein the mammal is a human. 10. Then method according to claim 8, wherein the mental disorder is schizophrenia. 11. The method according to claim 8, wherein the mental disorder is bipolar disorder.

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