AGOMELATINE FORMULATIONS COMPRISING AGOMELATINE IN THE FORM OF CO-CRYSTALS

摘要

A pharmaceutical formulation of agomelatine for oral use, comprising - agomelatine in the form of agomelatine co-crystals with organic acids and - pharmaceutically acceptable excipients, in which - the agomelatine co-crystals are used in the form of pre-blend of the agomelatine co- crystals with a glidant, - the ratio of the agomelatine co-crystals to the glidant in the pre-blend is lower than or equal to 30 : 1, and - the free-water content in the used pharmaceutically acceptable excipients is lower than or equal to 7% w/w.