PROCESS FOR PRODUCTION OF BUPRENORPHINE PHARMACEUTICAL PREPARATION TO BE APPLIED TO MOUTH MUCOSA

摘要

The invention aims at providing a process for the production of a buprenorphine pharmaceutical preparation to be applied to mouth mucosa. The process is characterized by comprising the step of preparing granules for rapid release layer containing buprenorphine hydrochloride crystals whose 90% cumulative diameter is 200µm or below, the step of preparing granules for sustained release layer containing buprenorphine hydrochloride crystals whose 90% cumulative diameter is 250µm or below, and the step of compressing both the granules into double-layer tablets.