Euro-Celtique S.a.

Vincenzo Martinelli

Hassan Mohammad

Malcolm Walden

Geoffrey Gerard Hayes

Steve Whitelock

Harjit Tamber

Derek Allan Prater

The invention relates to a process for preparing a controlled release pharmaceutical extrudate using a melt extruder,

Extrusion

Extrusion of a mix containing a pharmaceutically active agent can be achieved using a plasticizing excipient in an amount sufficient to act as plasticizer and also act as lubricant, thereby avoiding the need for inclusion of a lubricant. The invention provides multiparticulates with controlled release properties, substantially free of lubricant. The present invention is preferably directed to extruded multiparticulates containing an opioid such as oxycodone, an ammonium methacrylate copolymer such as Eudragit&#xae; RSPO, a plasticizing excipient such as preferably stearyl alcohol and a water permeability modifier such as preferably Eudragit&#xae; RLPO. The obtained multiparticulates show a release rate profile which is pH-independent.

Multiparticulates

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Cambridge, United Kingdom

Vincenzo Martinelli