Multiparticulates of preferably an opioid, and method of manufacturing using extrusion

摘要

Disclosed are melt extruded, controlled release multiparticulates containing a pharmaceutically active agent, an insoluble ammonium methacrylate copolymer, a water permeability modifier and a non-dominating plasticiser, substantially free of dominating or non-dominating lubricants selected from stearic acid, glyceryl behenate, magnesium stearate, calcium stearate, talc or silicone dioxide (fused silica), wherein the water permeability modifier is chosen from an insoluble hydrophilic wicking agent, a gelling agent which hydrates to form a gel to control the water movement, a high molecular weight polyethylene glycol, or a water permeable ammonium methacrylate copolymer, and wherein the amount of non-dominating plasticiser is 10 to 20 percent based on the total weight of ingredients. Also disclosed is a unit dose comprising said multiparticles, a process for preparing said multiparticles and the use of the unit dose in the treatment of analgesia.