A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/70 (2006.01) A61K 31/381 (2006.01) A61P 25/14 (2006.01)
Patent
CA 2485656
The invention relates to a polymer matrix suitable for the transdermal administration of rotigotine [(-)-5, 6, 7, 8-tetrahydro-6-[propyl[2-(2- thienyl)ethyl]amino]-1-naphtol], containing a matrix for the transdermal administration of rotigotine [(-)-5, 6, 7, 8-tetrahydro-6-[propyl[2-(2- thienyl)ethyl]amino]-1naphtol], containing a matrix polymer which is supersaturated with a rotigotine base. Said polymer matrix is characterised in that the part of the rotigotine which is not dissolved in the matrix polymer is dispersed in the matrix polymer as amorphous particles having a maximum mean diameter of 30 m, and the matrix is free of solubilisers, crystallisation inhibitors and dispersants. The invention also relates to a flat device for the transdermal administration of rotigotine, containing the above-mentioned, preferably silicon-based polymer matrix which is supersaturated with rotigotine, and a rear layer which is impermeable to the active ingredient.
L'invention concerne une matrice polymère appropriée pour l'administration transdermique de rotigotine [(-)-5, 6, 7, 8-tétrahydro-6-[propyl[2-(2-thiényl)éthyl]amino]-1-naphtol], contenant une matrice pour l'administration transdermique de rotigotine [(-)-5, 6, 7, 8-tétrahydro-6-[propyl[2-(2-thiényl)éthyl]amino]-1naphtol], contenant un polymère matriciel sursaturé en base de rotigotine. L'invention est caractérisée en ce que la proportion de rotigotine, non dissoute dans le polymère matriciel, est dispersée en tant que particules amorphes présentant un diamètre moyen maximal de 30 ?m dans le polymère matriciel, et en ce que la matrice est exempte de promoteur de solubilité, d'inhibiteur de cristallisation et d'agent de dispersion. L'invention concerne en outre un dispositif plat servant à l'administration transdermique de rotigotine, qui contient la matrice polymère décrite ci-dessus, sursaturée en rotigotine, de préférence à base de silicone, et une couche postérieure imperméable au principe actif.
Robic
Schwarz Pharma Ag
Ucb Pharma Gmbh
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