A Process For Preparing Paroxetine Hcl Which Limits Formation Of Pink

A Process For Preparing Paroxetine Hcl Which Limits Formation Of Pink Colored Compounds

Abstract: The present invention provides a process for preparing paroxetine HCl from paroxetine base which provides paroxetine HCl substantially free of pink-colored compounds or an impurity identified by an HPLC RRT of about 1.5. The processes of the present invention utilize a buffer, a molar ratio of HCl to paroxetine base of less than one, and crystallize/recrystallize in the presence of an effective amount of an anti-oxidant. A preferred way to create a buffer is by using ammonium chloride. A preferred anti-oxidant is ascorbic acid. The present invention also provides for re-crystallizing paroxetine HCl prepared by the above methods or any other methods in the presence of an effective amount of an anti-oxidant such as ascorbic acid. A preferred solvent system for recrystallization is a mixture of acetone and methanol. Processes of the present invention can combine these various features.

Patent Information

Application #

Filing Date

25 November 2003

Publication Number

17/2007

Publication Type

INA

Invention Field

PHARMACEUTICALS

Status

Email

remfry-sagar@remfry.com

Parent Application

Applicants

TEVA PHARMACEUTICAL INDUSTRIES LTD.

5 BASEL STREET, P.O. BOX 3190, PETAH TIQVA 49131,

Inventors

1. ILYA AVRUTOV

601 FINCH AVE. W. #1202, TORONTO, ONTARIO M2R 1N9,

2. GIDEON PILARSKI

12/29 ATAROTH, HOLON 58487,

Specification

Documents

Application Documents

#	Name	Date
1	1081-mumnp-2003-annexure to form 3(18-3-2004).pdf	2018-08-08
1	1081-mumnp-2003-wo international publication report(25-11-2003).pdf	2003-11-25
2	1081-mumnp-2003-form 5(25-11-2003).pdf	2003-11-25
2	1081-mumnp-2003-correspondence(15-4-2005).pdf	2018-08-08
3	1081-mumnp-2003-form 3(25-11-2003).pdf	2003-11-25
3	1081-mumnp-2003-correspondence(ipo)-(27-1-2010).pdf	2018-08-08
4	1081-mumnp-2003-form 2(title page)-(complete)-(25-11-2003).pdf	2003-11-25
4	1081-mumnp-2003-form 18(20-5-2005).pdf	2018-08-08
5	1081-MUMNP-2003-FORM 3(20-5-2004).pdf	2018-08-08
5	1081-mumnp-2003-form 2(complete)-(25-11-2003).pdf	2003-11-25
6	1081-mumnp-2003-power of authority(31-3-2004).pdf	2018-08-08
6	1081-mumnp-2003-form 1(25-11-2003).pdf	2003-11-25
7	1081-mumnp-2003-drawing(25-11-2003).pdf	2003-11-25
7	1081-mumnp-2003-claims(complete)-(25-11-2003).pdf	2003-11-25
8	1081-mumnp-2003-description(complete)-(25-11-2003).pdf	2003-11-25
9	1081-mumnp-2003-drawing(25-11-2003).pdf	2003-11-25
9	1081-mumnp-2003-claims(complete)-(25-11-2003).pdf	2003-11-25
10	1081-mumnp-2003-form 1(25-11-2003).pdf	2003-11-25
10	1081-mumnp-2003-power of authority(31-3-2004).pdf	2018-08-08
11	1081-MUMNP-2003-FORM 3(20-5-2004).pdf	2018-08-08
11	1081-mumnp-2003-form 2(complete)-(25-11-2003).pdf	2003-11-25
12	1081-mumnp-2003-form 2(title page)-(complete)-(25-11-2003).pdf	2003-11-25
12	1081-mumnp-2003-form 18(20-5-2005).pdf	2018-08-08
13	1081-mumnp-2003-form 3(25-11-2003).pdf	2003-11-25
13	1081-mumnp-2003-correspondence(ipo)-(27-1-2010).pdf	2018-08-08
14	1081-mumnp-2003-form 5(25-11-2003).pdf	2003-11-25
14	1081-mumnp-2003-correspondence(15-4-2005).pdf	2018-08-08
15	1081-mumnp-2003-wo international publication report(25-11-2003).pdf	2003-11-25
15	1081-mumnp-2003-annexure to form 3(18-3-2004).pdf	2018-08-08