Abstract: Aspects of the present application relate to a microcrystalline monoclinic form of asenapine maleate represented by structural Formula I; processes for its preparation; and pharmaceutically acceptable dosage forms thereof.
The following specification particularly describes the nature of the invention and the manner in which it is to be performed:
8. The monoclinic form of asenapine maleate which is stable to micronization of claim 6 with a powder X-ray diffraction (PXRD) pattern having at least three peaks located at about 9.5 20.3 21.9 23.3 25.1 26.1 26.6 29.0 or 29.9 ? 0.2 degrees 2-theta.
9. The monoclinic form of asenapine maleate which is stable to micronization of claim 6 with a powder X-ray diffraction (PXRD) pattern with peaks located substantially as illustrated by Fig.1.
10. The monoclinic form of asenapine maleate which is stable to micronization of claim 6 with any one or more of a powder X-ray diffraction (PXRD) pattern a differential scanning calorimetry (DSC) curve and a thermogravimetric analysis (TGA) curve substantially as illustrated by Figs. 1 3 and 4 respectively.
11. A process for the preparation of the monoclinic form of asenapine maleate which is stable to micronization of any one of claims 7 to 10 comprising:
a) providing a solution of asenapine in a solvent;
b) combining the solution of asenapine prepared in step a) with a solution of maleic acid in a solvent; and
c) isolating the monoclinic form of asenapine maleate.
12 A process for the preparation of the monoclinic form of asenapine maleate which is stable to micronization of any one of claims 7 to 10 comprising:
a) providing a solution of asenapine maleate in a solvent;
b) optionally seeding the solution prepared in step a with crystals of the monoclinic form; and
c) isolating the monoclinic form of asenapine maleate.
| # | Name | Date |
|---|---|---|
| 1 | 9837-CHENP-2012-AbandonedLetter.pdf | 2018-11-16 |
| 2 | 9837-CHENP-2012-FER.pdf | 2018-01-29 |
| 3 | abstract-9837-CHENP-2012.jpg | 2014-11-24 |
| 4 | ABSTRACT.pdf | 2014-11-24 |
| 4 | FORM 2.pdf | 2014-11-24 |
| 5 | ABSTRACT.pdf | 2014-11-24 |
| 5 | FORM 2.pdf | 2014-11-24 |
| 6 | abstract-9837-CHENP-2012.jpg | 2014-11-24 |
| 7 | 9837-CHENP-2012-FER.pdf | 2018-01-29 |
| 8 | 9837-CHENP-2012-AbandonedLetter.pdf | 2018-11-16 |
| 1 | SearchStrategyandreport_17-01-2018.pdf |