A NOVEL PROCESS FOR THE PREPARATION OF AMORPHOUS FORM OF

Application 489/CHE/2004 published 2006-06-23, filed 2004-05-28
The present invention provides a novel process for the preparation of amorphous form of Candesartan and pharmaceutically acceptable salts thereof. A process for the preparation of Candesartan Cilexetil amorphous form of the present invention comprises, a) Heating water to a temperatures of 45°C -50°C (optionally 0-10°C); b) Dissolving Candesartan Cilexetil in an aprotic polar solvents like Dimethyl sulfoxide, dimethylformamide and tetrahydrofuran c) Addition of reaction solution of step (b) to the water of step (a) under stirring; d) Filtering the precipitated solid of step (c) by conventional methods; e) Washing the obtained solid from step (d) with water; f) Drying the solid of step (e) at the temperatures comprising preferably 35-55°C to afford stable amorphous form of Candesartan and salts thereof; Candesartan Cilexetil can be shown as Formula (I)

Applicant

DR.REDDY'S LABORATORIES LIMITED,
7-1-27, AMEERPET,, HYDERABAD,500 016,, ANDHRA PRADESH,, INDIA.

Inventor

International Info

Classification: A61 K31/41;31/4184
Publication Number: