EP3492070A1 — Process and device for preparing a solid dispersion

USPTO Abstract

The present invention relates to a melt extrusion process for preparing a solid dispersion comprising a pharmaceutically active ingredient, a polymeric binder, and, optionally, one or more auxiliary agents, comprising a) placing a pre-determined amount of the polymeric binder, a pre-determined amount of the active ingredient, and, optionally, a pre-determined amount of the auxiliary agent(s) in a melting vessel; melting the polymeric binder with agitation to disperse the active ingredient in the polymeric binder to obtain a molten pre-dispersion; b) feeding the pre-dispersion into an extruder to homogenize the pre-dispersion and release a melt through a die; and c) allowing the melt to solidify.