Patent ID: 8808729
Filing Date: 2014-08-19
Classification: A61K

Abstract:
1. A film-shaped therapeutic system comprising at least three layers connected with each other for transmucosal administration of active substances, wherein said at least three layers include: a mucoadhesive layer which is mucoadhesive in an aqueous environment; and a backing layer comprising at least one neutralized polymethyl methacrylate and containing an active substance and a pigment, wherein said backing layer is at least two-layered and comprises a middle layer disposed upon said mucoadhesive layer and an outer layer, wherein one of said layers of said at least two-layered backing layer does not contain said pigment or contains a lower portion of said pigment than is contained in the respective other layer or layers of said at least two-layered backing layer; wherein said mucoadhesive layer swells in an aqueous medium but is insoluble or poorly soluble in the aqueous medium and contains a polymer mixture comprising at least one hydrophilic mucoadhesive polymer embedded or dispersed in a matrix comprising at least one polyvinyl alcohol, said mucoadhesive polymer being poly(methyl vinyl ether maleic anhydride); wherein said pigment is provided in an amount in the range of 60 wt.-80 wt. % relative to the polymer portion in the respective layer of the at least two-layered backing layer; and wherein the weight ratio of said mucoadhesive polymer to said polyvinyl alcohol is in the range of 50:1 to 1:50.