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"Crystalline Form Of Fosamprenavir Calcium"

Abstract: The present invention relates to a crystalline form of fosamprenavir calcium. The crystalline form of the present invention is designated as Form II of fosamprenavir calcium. The present invention also relates to a process for the preparation of crystalline Form II of fosamprenavir calcium. The present invention further relates to a pharmaceutical composition comprising crystalline Form II of fosamprenavir calcium.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
30 January 2012
Publication Number
36/2016
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

RANBAXY LABORATORIES LIMITED
12TH FLOOR, DEVIKA TOWER, 6 NEHRU PLACE, NEW DELHI-110019, INDIA,

Inventors

1. SATISH MANOHAR BHOGE,
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON - 122001, HARYANA, INDIA.
2. PRAKASH KSHIRSAGAR
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON - 122001, HARYANA, INDIA.
3. SANTOSH RICHHARIYA
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON - 122001, HARYANA, INDIA.
4. KAPTAN SINGH
RANBAXY LABORATORIES LIMITED, PLOT NO. 20, SECTOR - 18, UDYOG VIHAR INDUSTRIAL AREA, GURGAON - 122001, HARYANA, INDIA.

Specification

WE CLAIM:
1. Crystalline Form II of fosamprenavir calcium characterized by an XRPD pattern comprising interplanar spacing (d) values substantially at 15.98, 9.25, 8.02, 6.07, 5.35, 5.04, 2.86 and 2.70 (A).
2. Crystalline Form II of fosamprenavir calcium according to claim 1 characterized by an XRPD pattern comprising interplanar spacing (d) values substantially at 15.98, 9.25, 8.02, 6.47, 6.07, 5.35, 5.04, 4.61, 4.46, 4.35, 4.13, 4.07, 4.00, 3.69, 3.63, 3.51, 3.46, 3.42, 3.27, 3.18, 3.04, 2.93,2.89, 2.86,2.77, 2.70,2.63, 2.58, 2.53, 2.43,2.34 and 2.29 (A).
3. Crystalline Form II of fosamprenavir calcium having substantially the same FTIR pattern as depicted in Figure 5.
4. A process for the preparation of crystalline Form II of fosamprenavir calcium, wherein the process comprises:

a) dissolving fosamprenavir calcium in a water miscible organic solvent, wherein the water miscible organic solvent comprises a propanol,
b) treating the solution obtained in step a) with water and
c) isolating crystalline Form II of fosamprenavir calcium from the mixture thereof.

5. A process according to claim 4, wherein the water miscible organic solvent further comprises methanol, ethanol, or a mixture thereof.
6. A pharmaceutical composition comprising crystalline Form II of fosamprenavir calcium and a pharmaceutically acceptable carrier.
7. A method of treating HIV infection comprising a step of administering to a patient in need thereof a therapeutically effective amount of crystalline Form II of fosamprenavir calcium.

Documents

Application Documents

# Name Date
1 848-delnp-2012-Form-2.pdf 2012-09-10
2 848-delnp-2012-Form-1.pdf 2012-09-10
3 848-delnp-2012-Drawings.pdf 2012-09-10
4 848-delnp-2012-Description (Provisional).pdf 2012-09-10
5 848-delnp-2012-Correspondence Others.pdf 2012-09-10
6 848-delnp-2012-Claims.pdf 2012-09-10
7 848-delnp-2012-Abstract.pdf 2012-09-10