Method and device for providing nicotine replacement therapy...

A - Human Necessities – 61 – K

Patent

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A61K 9/70 (2006.01) A61K 31/465 (2006.01)

Patent

CA 2166869

A skin or buccal patch for providing nicotine replace- ment therapy which comprises a matrix type laminated com- posite in which the matrix is composed of a mixture of nico- tine in a polymer (12) wherein the amount of nicotine in the matrix, diffusion coefficient of nicotine in the matrix and the thickness of matrix are such that the release of nicotine is: (1) controlled by the patch; (2) rapid and at a relatively high flux over the prescribed wearing time of patch; and (3) such that a substantial proportion of the nicotine initially in the patch has been released at the end of the prescribed wearing time. The laminated composite also comprises an impermeable backing layer (11) and a removable release liner (13).

Le tampon (ou "patch") applicable sur la peau ou dans la bouche est destiné à l'administration d'une thérapie de substitution de la nicotine. Il est constitué d'un composite laminé de type à matrice dans lequel la matrice est un mélange de nicotine et de polymère (12). La quantité de nicotine contenue dans la matrice, le coefficient de diffusion de la nicotine dans la matrice ainsi que l'épaisseur de la matrice sont conçus pour que la distribution de nicotine réponde aux exigences suivantes: (a) régulation par la matrice; (b) débit rapide et taux relativement élevé pendant toute la durée d'utilisation du tampon; (c) une proportion importante de la nicotine initialement contenue dans le tampon doit avoir été délivrée à la fin de la période prescrite d'utilisation du tampon. Le composé laminé comporte également une couche support imperméable (11) ainsi qu'une pellicule de protection amovible (13).

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