Multi-layer drug delivery device and method of manufacturing...

A - Human Necessities – 61 – L

Patent

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Details

A61L 27/54 (2006.01) A61J 3/00 (2006.01) A61K 47/30 (2006.01) A61L 27/18 (2006.01) A61L 27/34 (2006.01) A61L 27/40 (2006.01) A61L 27/58 (2006.01) A61L 31/08 (2006.01) A61L 31/12 (2006.01) A61L 33/06 (2006.01) A61F 2/82 (2006.01) A61K 31/337 (2006.01) A61M 31/00 (2006.01)

Patent

CA 2527666

This application relates to a multi-layer drug delivery device and a method of manufacture. The device comprises a substrate; at least one first layer on the substrate containing the drug and a first solvent; and at least one second layer applied to the first layer to regulate release of the drug from the first layer, wherein the second layer comprises a polymer. The first solvent substantially prevents direct contact between the drug and the polymer. When applied to the first layer, the polymer is preferably dissolved in a second solvent which is immiscible with the first solvent to substantially prevent inter-diffusion between the first and second layers. In one application the substrate is a medical device, such as an implantable stent, having a biocompatible outer surface. The second layer is preferably biodegradable, bioabsorbable and/or bioresolvable in vivo to permit gradual exposure of the first layer and elution of the drug therefrom.

Cette invention concerne un dispositif multicouche d'administration de médicaments et son procédé de production. Le dispositif comprend un substrat, au moins une première couche sur le substrat contenant le médicament et un premier solvant, et au moins une seconde couche appliquée sur la première couche afin de réguler la libération du médicament de la première couche, la seconde couche contenant un polymère. Le premier solvant empêche sensiblement un contact direct entre le médicament et le polymère. Lorsqu'il est appliqué à la première couche, le polymère est de préférence dissous dans un second solvant lequel n'est pas miscible au premier solvant afin d'empêcher sensiblement une interdiffusion entre les première et seconde couches. Dans une application, le substrat est un dispositif médical tel qu'une endoprothèse implantable présentant une surface extérieure biocompatible. La seconde couche est de préférence biodégradable, bioabsorbable et/ou biorésolvable in vivo pour permettre l'exposition graduelle de la première couche ainsi que l'élution du médicament de celle-ci.

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