PROCESS FOR THE PREPARATION OF STABLE AND HIGHLY PURE CRYSTALLINE FORM 2 OF BILASTINE

摘要

Disclosed herein is a consistently reproducible process for the production of highly pure and stable crystalline Form 2 of Bilastine essentially free of other polymorphic forms. Provided also herein is a pharmaceutical composition comprising the highly pure crystalline Form 2 of Bilastine essentially free from other crystalline forms made by the process disclosed herein, and one or more pharmaceutically acceptable excipients.