Title of Invention

A NOVEL METHOD FOR PREPARING HIGH PURITY ANHYDROUS PAROXETINE HYDROCLORIDE ISOPROPANOL SOLVATE

Abstract A novel form of anhydrous Paroxetine hydrochloride is prepared by dissolving Paroxetine base in ispropanol, which is treated with a solution of hydrougen chloride in isopropanol. 50 to 60% of isopropanol used in the reaction is then distilled at atmospheric pressure. The product thus obtained after drying contains isopropanol not more than 3% and water content which is less than 2.0% The product is found to be stable even after 3 days upon direct exposure t 75% RH at 40C andt the product is unchanged as confirmed by X-ray powder difractogram. The product is also found t be stable for three months as per ICH satiability conditions.
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Documents:


Patent Number 235757
Indian Patent Application Number 614/MUM/2003
PG Journal Number 35/2009
Publication Date 28-Aug-2009
Grant Date 21-Aug-2009
Date of Filing 12-Jun-2003
Name of Patentee CADILA HEALTHCARE LIMITED
Applicant Address ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
Inventors:
# Inventor's Name Inventor's Address
1 SHAH, ASHOK HASMUKHALAL CADILA HEALTHCARE LIMITED ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
2 PATEL, MAHESH SANKARBHAI ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
3 MANAKIWALA, SATISH CHAMPAKLAL. ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
4 AGRAWAL VIRENDRAKUMAR. ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
5 PANDITA KANWAL ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
6 PATEL PANKAJ RAMANBHAI ZYDUS TOWER, SATELLITE CROSS ROAD, AHMEDABAD-380 015
PCT International Classification Number C07D405/12
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA