| abstract |
Crystalline forms of vortioxetine hydrobromide, designated as form-M 1 , form-M 2 , form-M 3 , and form-M 4 are disclosed herein.The present disclosure also provides apharmaceutical premix of crystalline form-M 2 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. |