Multiparticulates of preferably an opioid, and method of manufacturing using extrusion
申请人:EURO-CELTIQUE S.A.
公开号:EP2269582A2
公开(公告)日:2011-01-05
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.
MULTIPARTICULATES OF PREFERABLY AN OPIOID, AND METHOD OF MANUFACTURING USING EXTRUSION
申请人:Euroceltique S.A.
公开号:EP1809249A2
公开(公告)日:2007-07-25
Multiparticulates
申请人:Hayes Geoffrey Gerard
公开号:US20080260815A1
公开(公告)日:2008-10-23
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.