abstract |
The present invention is concerned with a process for the preparation of 2n-butyl-4-spirocyclopentane-1-[(2'-(tetrazol-5-yl)biphenyl-4-yl) methyl]-2-imidazolin-5-one hydrochloride, irbesartan hydrochloride, novel hydrated and anhydrous crystalline forms thereof, amorphous irbesartan hydrochloride, formulations containing the same, therapeutic uses thereof and methods of treatment employing the same. The process of the present invention is a one-pot process which comprises reacting intermediate compounds 2n-butyl-1, 3-diazaspiro [4,4] non-1-en-4-one and 5-(4' -bromomethyl-biphenyl-2-yl)-1-trityl-lH-tetrazole. |