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Asenapine Maleate

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.

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Patent Information

Application #
Filing Date
21 November 2012
Publication Number
01/2015
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

Dr. Reddys Laboratories Limited
8-2-337  Road No. 3  Banjara hills  Hyderabad  Andhra Pradesh  India- 500034
Dr. Reddy’s Laboratories Inc.
200 Somerset Corporate Boulevard  7th Floor  Bridgewater  New Jersey  US-08807

Inventors

1. Katkam Srinivas
H.No: 13-1/32/3 Saipuri Colony Malkajgiri Hyderabad-500047  Andhra Pradesh  India.
2. Polavarapu Srinivas
H.No : 48-509 Flat No –G-3 Maruthi Enclave  Ganesh Nagar  Hyderabad-500054 Andhra Pradesh  India.
3. Yaddanapudi Venkata Madhavi
H.No: 6-291/2  Venkateshwara Nagar  Chintal  Hyderabad-500054 Andhra Pradesh  India.
4. Vinigari Krishna
H.No : 2-121  Shivaji Nagar  Devarakadra Mandal  Mahaboob Nagar   Hyderabad- 509204  Andhra Pradesh  India.
5. Pagadala Narasimha Rao
H.No : 174  Temple Raod  J.P.Nagar Miyapur  Hyderabad - 500050 Andhra Pradesh  India.
6. Sagyam Rajeshwar Reddy
Plot No. 1322 &1323  Flat No. 204  Vindhya Hills  Pragathi Nagar  Hyderabad-500072

Specification

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.

Documents

Application Documents

# 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

Search Strategy

1 SearchStrategyandreport_17-01-2018.pdf