Methylphenidate extended release therapeutic drug delivery...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/4458 (2006.01) A61K 9/22 (2006.01) A61K 9/26 (2006.01)

Patent

CA 2718639

The present invention relates to an extended release therapeutic drug delivery system comprising a controlled re-lease core matrix composition comprising an active pharmaceutical ingredient such as a central nervous system stimulant (e.g., methylphenidate) and a release controlling agent (i.e., HPMC -K4M, HPMC-K I00M CR or HPMC-K 15 M CR) as well as a con-trolled release coating layer composition covering the core matrix composition, which comprises controlled release polymers such as Eudragit RL 30D. The extended release therapeutic drug delivery system is for use once or twice daily administration. The present invention also relates to processes for manufacturing such an extended release therapeutic drug delivery system.

L'invention porte sur un système dadministration de médicament thérapeutique à libération prolongée comprenant: une composition de matrice de noyau renfermant un principe actif tel qu'un stimulant du SNC (p.ex. du méthylphénidate) et un agent régulant la libération (HPMC -K4M, HPMC-K IOOM CR ou HPMC-K 15 M CR); ainsi qu'une composition d'enrobage à libération contrôlée recouvrant la matrice de noyau faite de polymères à libération contrôlée tels que l'Eudragit RL 3OD. Ledit système s'administre une ou deux fois par jour. L'invention porte également sur le procédé de fabrication de ce système dadministration de médicament thérapeutique à libération prolongée.

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