Dosage forms and compositions for osmotic delivery of...

A - Human Necessities – 61 – K

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Details

A61K 9/00 (2006.01) A61K 9/22 (2006.01) A61K 31/485 (2006.01) A61P 25/04 (2006.01)

Patent

CA 2487786

Dosage forms, compositions and methods for the controlled release of oxycodone over a prolonged period of time are described. The present invention discloses a novel means for delivering varying doses of oxycodone using a drug composition having only oxycodone, a polymer carrier and varying amounts of salt to provide a particular viscosity of the hydrated drug core for delivery of the drug at the desired release rate. The present invention functions by modulating the viscosity of the hydrated drug layer in operation by the addition or reduction of salts in the drug composition. The system is independent of solubility enhancers or pH modifiers. The sustained release dosage forms provide therapeutically effective average steady-state plasma oxycodone concentrations when administered once per day.

L'invention concerne des formes galéniques, des compositions et des procédés de libération commandée de l'oxycodone pendant une durée prolongée. L'invention concerne également de nouveaux moyens permettant d'administrer diverses posologies de l'oxycodone au moyen d'une composition médicamenteuse comprenant uniquement de l'oxycodone, un excipient polymère et diverses quantités de sel, de manière à obtenir une certaine viscosité du noyau du médicament hydraté, aux fins d'administration du médicament à une vitesse de libération souhaitée. Le système selon l'invention consiste à moduler la viscosité de la couche de médicament hydratée pendant l'utilisation, par ajout ou réduction de sels dans la composition médicamenteuse. Le système ne dépend pas d'agents d'amélioration de la solubilité ou de modificateurs de pH. Les formes galéniques à libération prolongée fournissent des concentrations plasmatiques stationnaires moyennes de l'oxycodone efficaces sur le plan thérapeutique quand elles sont administrées une fois par jour.

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