Multilayer pharmaceutical form comprising a substance having...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/20 (2006.01) A61K 9/28 (2006.01)

Patent

CA 2544497

The invention relates to a multilayer pharmaceutical dosage form for the controlled release of active substances, containing: a) a core layer containing a substance that acts in a modulatory manner with regard to the release of active substances, optionally a neutral core and/or an active substance; b) an inner control layer that influences the release of the substance that acts in a modulatory manner and of the optionally contained active substance from the core layer, containing pharmaceutically useable polymers, waxes, resins and/or proteins; c) an active substance layer containing a pharmaceutical active substance and, optionally, a substance that acts in a modulatory manner; d) an outer control layer containing a (meth)acrylate copolymer or a mixture consisting of a number of (meth)acrylate copolymers comprised of 98 to 85 C1-C4 alkyl esters of (meth)acrylic acid and 2 to 15 % by weight of methacrylate monomers with a quaternary ammonium group in the alkyl radical and optionally containing pharmaceutically useable polymers that are insoluble in water, whereby the layers can contain, in addition and in a known manner, pharmaceutically conventional adjuvants.

L'invention concerne une forme galénique multicouche utilisée pour la libération contrôlée de principe actif, qui contient : a) une couche centrale contenant une substance à action modulatrice par rapport à la libération de principe actif, éventuellement un noyau neutre et/ou un principe actif ; b) une couche de contrôle intérieure, qui influe sur la libération de la substance à action modulatrice et du principe actif éventuellement contenu, hors du noyau, ladite couche contenant des polymères utilisables dans le domaine pharmaceutique, des cires, des résines et/ou des protéines ; c) une couche de principe actif contenant un principe actif pharmaceutique et éventuellement une substance à action modulatrice ; d) une couche de contrôle extérieure contenant un (méth)acrylate-copolymère ou un mélange desdits copolymères, à base de 98 à 85 alkylesters C¿1?-C¿4? d'acide (méth)acrylique et de 2 à 15 % en poids de méthacrylate-monomères ayant un groupe ammonium quaternaire dans le reste alkyle, et éventuellement d'autres polymères insolubles dans l'eau pouvant s'utiliser dans le domaine pharmaceutique, lesdites couches pouvant en outre contenir des auxiliaires courants connus en soi dans le domaine pharmaceutique.

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