Euro-Celtique S.a.

Purdue Pharma L.p.

Geoffrey Gerard Hayes

Hassan Mohammad

Malcolm Walden

Helen Kathleen Danagher

Jonathon Oliver Whitehouse

Harjit Tamber

Thinnayam Naganathan Krishnamurthy

Ricardo Alberto Vargas Rincon

Steve Whitelock

Derek Allan Prater

Vincenzo Martinelli

Gerhard Josef Heun

Jonothon Oliver Whitehouse

Alberto Vargas Ricardo

The present invention relates to prolonged release pharmaceutical dosage forms comprising hydromorphone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof for use in the treatment of pain.

Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome

The present invention relates to prolonged release pharmaceutical dosage forms, the manufacture thereof as well as their use for administration to human beings.

Manufacturing of active-free granules and tablets comprising the same

The present invention relates to prolonged release pharmaceutical dosage forms, the manufacture thereof as well as their use for administration to human being.

Combination of active loaded granules with additional actives

The present invention pertains to oral immediate release pharmaceutical compositions suitable for treating patients suffering from pain comprising oxycodone and naloxone or their pharmaceutically acceptable salts.

Immediate release pharmaceutical compositions comprising oxycodone and naloxone

Pharmaceutical compositions comprising hydromorphone and naloxone

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

According to the invention glyceryl monostearate and a polymeric binder are employed as a spheronising aid in the manufacture of pharmaceutical spheroids containing no or substantially no microcrystalline cellulose. The spheroids can contain one or more therapeutically active agent which undergoes no or substantially no degradation when stored under accelerated temperature and humidity conditions. A coating may be applied to the spheroids; when present, the coating is preferably a controlled release coating.

Pharmaceutical spheroids

A neutral poly(ethyl acrylate, methyl methacrylate) copolymer is employed as a carrier in the manufacture of pharmaceutical formulations containing an active ingredient. The formulations are preferably made by melt extrusion, and can have rubbery characteristics and can exhibit tamper resistance.

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Cambridge, United Kingdom

Geoffrey Gerard Hayes