NOVEL CRYSTALLINE FORMS OF VORTIOXETINE, PREMIXES, AND PROCESSES FOR THE PREPARATION THEREOF

摘要

Crystalline forms of vortioxetine hydrobromide, designated as form-M1, form-M2, form-M3, and form-M4are disclosed herein.The present disclosure also provides apharmaceutical premix of crystalline form-M2 of vortioxetine hydrobromide and pharmaceutically acceptable excipients and a process for the preparation thereof, as well as a pharmaceutical premix of amorphous vortioxetine hydrobromide and pharmaceutical acceptable excipients and a process for the preparation thereof. In some embodiments, the generation of a premix that includes amorphous vortioxetine hydrobromide and β-cyclodextrin was found to be particularly stable and advantageous.