Process for preparating ivabradine hydrochloride form IV and methods of treatment of disease using ivabradine hydrochloride form IV

摘要

Ivabradine hydrochloride Form IV, its pharmaceutical composition, process for its preparation, and its use as therapeutically active ingredient and pharmaceutical compositions containing Ivabradine hydrochloride Form IV.

主权项

1. A process for preparing ivabradine hydrochloride Form IV with a powder X-ray diffraction comprising the following degrees 2 theta (±0.2) peaks: 8.74, 15.55, 17.17, 19.89, and 24.29, wherein the X-ray diffraction is measured using a CuKα radiation, the process comprising:
a) slurrying ivabradine hydrochloride in a solvent system comprising toluene, ethanol, acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl acetate, isopropyl acetate and mixtures thereof; wherein said step of slurrying ivabradine occurs at a temperature of lower than 60° C. and the reaction time for said step of slurrying ivabradine is less than 48 h; and b) isolating the ivabradine hydrochloride Form IV.