NOVEL CRYSTALLINE FORM OF ESOMEPRAZOLE MAGNESIUM TRIYHDRATE AND PROCESS FOR PREPARATION THEREOF
852/MAS/2002 A (852/MAS/2002)
Filed on 2002-11-18
Publication date 2007-08-03
The present invention relates to the novel crystalline Fonn-II of Esomeprazole magnesium trihydrate salt and the process for the preparation thereof. Esomeprazole magnesium trihydrate salt is chemically known as (-) 5-methoxy-2- [[(4-methoxy-3, 5- dimethyl-2-pyridinyl)-methyl] sulphinyl]-IH-benzimidazole magnesium trihydrate, which is represented by the Fonnula (1). The process for the preparation of novel crystalline Fonn-II of Esomeprazole magnesium trihydrate salt comprises the reaction of Esomeprazole with magnesium metal in a mixture of methanol and dichloromethane to result the magnesium salt of Esomeprazole. The resulted salt is successively washed with acetone, recrystallized in methanol and isolated the solid using mixture of water and acetone to afford the novel crystalline Form-II of Esomeprazole magnesium trihydrate salt. The process of the present invention is simple, eco-friendly and cost effective and commercially viable over prior art process.
Applicant
Dr.REDDY'S LABORATORIES LIMITED
7-1-27, AMEERPET, HYDERABAD-500 016 Andhra Pradesh India
Inventor
MANNE SATYANARAYANA REDDY, MUPPA KISHORE KUMAR, KOILKONDA PURANDHAR, LEKKALA AMARNATH REDDY
International Information
Classification
C07D 401/12
Publication number
NA