MULTILAYERED TRANSMUCOSAL THERAPEUTIC SYSTEM

摘要

A film-shaped therapeutic system comprising at least two layers connected with each other, for transmucosal administration of active substances. The system has a layer which is mucoadhesive in an aqueous environment and a mono-layered or multi-layered backing layer. At least one of these layers contains an active substance. The mucoadhesive layer is capable of swelling in an aqueous media, but is insoluble or only poorly soluble in an aqueous media. A process for treating a patient by medicinal therapy or prophylaxis by the film-shaped therapeutic system is also provided.

主权项

1. A process for treating a patient by medicinal therapy or prophylaxis comprising the steps of:
applying 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; anda 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; andwherein the weight ratio of said mucoadhesive polymer to said polyvinyl alcohol is in the range of 50:1 to 1:50, onto the oral mucosa of a patient in need of medicinal therapy or prophylaxis for a period of up to 24 hours; andreleasing at least one active substance with an initial burst dose and a subsequent maintenance dose.