Novel oral controlled release pharmaceutical formulations

Details Novel oral controlled release pharmaceutical formulations Novel oral controlled release pharmaceutical formulations

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 31/137 (2006.01)

Patent

CA 2718753

The present invention relates to a controlled-release bead containing a pharmaceutically active ingredient. The controlled-release bead comprises a core made of a substantially water-insoluble inert material. A first layer is disposed over the core, with the first layer comprising a substantially water-soluble polymer. A second layer disposed over the first layer, the second layer containing the pharmaceutically active ingredient and a polymer. Finally, a third layer is disposed over the second layer, with the third layer comprising a controlling release polymeric system. The present invention also relates to dosage forms, such as tablets and capsules, comprising the controlled-release beads, and methods of manufacturing the controlled-release beads.

La présente invention concerne une bille à libération contrôlée contenant un principe pharmaceutiquement actif. La bille à libération contrôlée comprend un noyau constitué dun matériau inerte sensiblement insoluble dans leau. Une première couche est placée sur le noyau, la première couche comprenant un polymère sensiblement hydrosoluble. Une deuxième couche est placée sur la première couche, la deuxième couche comprenant le principe pharmaceutiquement actif et un polymère. Enfin, une troisième couche est placée sur la deuxième couche, la troisième couche comprenant un système polymère de contrôle de la libération. La présente invention concerne également des formes pharmaceutiques, telles que des comprimés et des gélules, comprenant les billes à libération contrôlée, et des procédés de fabrication des billes à libération contrôlée.

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