Transdermal therapeutic system containing fentanyl or...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/4468 (2006.01) A61F 13/00 (2006.01) A61K 9/70 (2006.01) A61K 47/30 (2006.01) A61K 47/32 (2006.01) A61L 15/22 (2006.01) A61L 15/24 (2006.01) A61L 15/44 (2006.01) A61L 15/58 (2006.01)

Patent

CA 2457401

The invention relates to a transdermal therapeutic system (TTS), comprising a backing layer, which is permeable to the active ingredient, at least one matrix layer, comprising fentanyl or an active agent analogous to fentanyl, based on polyacrylate and a protective layer to be removed before usage, characterised in that the polyacrylate polymer is self-adhesive, free of carboxyl groups, has a saturation solubility for fentanyl of 3 to 20 wt. %, preferably of 4 to 12 and particularly of 5 to 10 wt. % and the layers contain at least 80 % of the included active ingredient in a molecularly-dispersed, dissolved form.

L'invention concerne un système thérapeutique transdermique (TTS) comprenant une couche de base imperméable au principe actif, au moins une couche matricielle contenant du fentanyle ou un principe actif analogue au fentanyle, ladite couche étant à base de polyacrylate, ainsi qu'une couche de protection à enlever avant utilisation. Ledit système se caractérise en ce que le polymère polyacrylate est auto-adhésif et exempt de groupes carboxyle, qu'il présente pour le fentanyle, une solubilité à saturation de l'ordre de 3 à 20 pour-cent en poids, de préférence une solubilité à saturation comprise entre 4 et 12 et plus spécifiquement une solubilité à saturation de l'ordre de 5 à 10 pour-cent en poids, et en ce que les couches contenant le principe actif contiennent au moins 80 pour-cent en poids du principe actif incorporé, sous forme dissoute moléculairement dispersée.

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