Multiparticulates

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/16 (2006.01) A61K 31/485 (2006.01)

Patent

CA 2576275

Extrusion of a mix containing a pharmaceutically active agent can be achieved using a plasticising excipient in an amount sufficient to act as plasticiser 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~ RSPO, a plasticising excipient such as preferably stearyl alcohol and a water permeability modifier such as preferably Eudragit~ RLPO. The obtained multiparticulates show a release rate profile which is pH-independent.

Selon l'invention, l'extrusion d'un mélange contenant un agent pharmaceutiquement actif peut être obtenue par utilisation d'un excipient de plastification en une quantité suffisante pour agir en tant que plastifiant et également pour agir en tant que lubrifiant, rendant ainsi inutile l'inclusion d'un lubrifiant. L'invention concerne des formes multiparticulaires présentant des propriétés de libération contrôlée, sensiblement dépourvues de lubrifiant.

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