Drug-containing adhesive composite transdermal delivery device

A - Human Necessities – 61 – M

Patent

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Details

A61M 37/00 (2006.01) A61F 13/02 (2006.01) A61K 9/70 (2006.01)

Patent

CA 2183083

A method for making a transdermal drug delivery device for heat sensitive and volatile drugs is disclosed. The device contains a drug-containing adhesive composite layer having an impermeable backing material laminated to the distal surface thereof and a proximal peelable impermeable backing material adapted for removal for administering a drag to the skin or mucosa laminated to the proximal surface thereof. The figure provides a partly schematic, sectional view of the transdermal drug delivery device (10) including the substantially drug-impermeable distal backing (14), a drug laden adhesive composite (18) and a substantially drug impermeable proximal release liner (22). The adhesive composite (18) is comprised of a distal adhesive layer (19), a proximal adhesive layer (20) and a gelled drag layer (21) disposed therebetween. The device is produced by extruding the drag in gel form onto at least one exposed surface of a first or second adhesive laminate such that the adhesive layers and gelled drug are combined to form the drug-containing adhesive composite layer having the distal and proximal surfaces covered by the respective backing materials. This process is particularly adaptable to the formulation of nicotine-containing patches.

Procédé de fabrication d'un système d'apport transdermique de médicaments, destiné à des médicaments volatils et thermosensibles. Ce système comprend une couche composite adhésive, contenant un médicament, sur la surface distale de laquelle un matériau support imperméable est appliqué de manière stratifiée, et sur la surface proximale de laquelle est appliqué de manière stratifiée un matériau support imperméable pelable proximal, s'enlevant pour permettre l'administration d'un médicament par la peau ou les muqueuses. La figure présente une vue en coupe, partiellement schématique, dudit système (10), celui-ci comprenant le matériau support distal (14), pratiquement imperméable au médicament, un composite adhésif (18), chargé de médicament, ainsi qu'un revêtement de séparation proximal (22), pratiquement imperméable au médicament. Le composite adhésif (18) se compose d'une couche adhésive distale (19), d'une couche adhésive proximale (20), ainsi que d'une couche de médicament gélifié (21) disposée entre les deux. On produit ce système en extrudant le médicament sous forme de gel sur au moins une surface exposée d'un premier ou second matériau adhésif stratifié de façon que les couches adhésives et le médicament gélifié soient associés pour former la couche composite adhésive contenant le médicament et présentant des surfaces distale et proximale recouvertes des matériaux support respectifs. Ce procédé convient particulièrement à la formulation de timbres transdermiques contenant de la nicotine.

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