TRANSDERMAL THERAPEUTICS SYSTEM WITH BARRIER LAYER

Abstract

The invention relates to a transdermal therapeutic system that includes a) a backing layer which faces away from the skin, is impermeable to the active substance, and is equipped with an adhesive layer for fixing onto the skin, b) an active substance reservoir which contains at least one active substance, c) a barrier layer which faces the skin, adjoins the active substance reservoir, is impermeable to the active substance and has at least one opening, and d) a removable protective layer, in which the backing layer which is equipped with the adhesive layer projects beyond the barrier layer on all sides.

Claims

1. A transdermal therapeutic system comprising a) a backing layer that is facing away from skin and is impermeable to active substance(s), said backing layer comprising a pressure-sensitive- adhesive layer for attachment to the skin, b) an active substance reservoir comprising at least one active substance, c) a skin-facing barrier layer that adjoins the active substance reservoir, is impermeable to the active substance, and has at least one opening, d) a removable protective layer, wherein the backing layer that is furnished with the pressure-sensitive-adhesive layer protrudes beyond the barrier layer on all sides and wherein the barrier layer protrudes beyond the active substance reservoir on all sides.

2. The transdermal therapeutic system as claimed in claim 1, wherein the barrier layer has a thickness from 5 to 20 μm.

3. The transdermal therapeutic system as claimed in claim 1, wherein the at least one opening has an area from 0.07 to 176.72 mm.sup.2.

4. The transdermal therapeutic system as claimed in claim 1, wherein the at least one opening in the barrier layer is circular, oval or polygonal in shape.

5. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir is a pressure-sensitive-adhesive layer.

6. The transdermal therapeutic system as claimed in claim 1, wherein the barrier layer comprises a pressure-sensitive-adhesive layer.

7. The transdermal therapeutic system as claimed in claim 1, wherein the barrier layer comprises a material selected from the group consisting of polyethylene terephthalate, plasticized vinyl acetate-vinyl chloride copolymers, nylon, ethylene-vinyl acetate copolymers, plasticized polyvinyl chloride, polyurethane, polyvinylidene chloride, polypropylene, polyethylene and polyamide.

8. The transdermal therapeutic system as claimed in one of claim 1, wherein the pressure-sensitive-adhesive layer comprises, as base polymers, polymers selected from the group consisting of polyacrylates, poly(meth)acrylates, polyacrylic acid, cellulose derivatives, polyisobutylene, ethylene-vinyl acetate copolymers, natural rubbers, synthetic rubbers, hot-melt silicone-based adhesives and pressure-sensitive silicone-based adhesives.

9. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir comprises at least one auxiliary or additive selected from the group consisting of solvents, solubilizers, plasticizers, permeation improvers, pH regulators, antioxidants, and preservatives.

10. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir comprises one or more solubilizers, and the concentration of the solubilizer(s) is between 1% and 50% by weight, based on the entire system.

11. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir is an active-substance-containing matrix, and the active substance reservoir consists of one, two or several matrix layers.

12. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir is an active-substance-containing matrix, and said matrix is a synthetic resin matrix or plastic matrix that comprises, as base polymer(s), one or more polymers selected from the group consisting of polyacrylates, poly(meth)acrylates, polyacrylic acid, cellulose derivatives, isobutylene, ethylene-vinyl acetate, natural rubbers, synthetic rubbers, and hot-melt adhesives.

13. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir is an active-substance-containing matrix in which the active substance is present adsorbed on a fiber material.

14. The transdermal therapeutic system as claimed in claim 1, wherein the active substance reservoir comprises a pressure-sensitive-adhesive polymer or a combination of pressure-sensitive-adhesive polymers, wherein the pressure-sensitive-adhesive polymer is selected from the group consisting of polyacrylates, polymethacrylates, polydimethylsiloxanes, polyvinyl acetates, polyisobutylenes, styrene-isoprene-styrene block copolymers, styrene-butadiene-styrene block copolymers, polyterpenes, ethylene-vinyl acetate copolymers, rubbers, and synthetic rubbers.

15. The transdermal therapeutic system as claimed in claim 2, wherein the barrier layer has a thickness from 8 to 17 μm.

16. The transdermal therapeutic system as claimed in claim 2, wherein the barrier layer has a thickness from 10 to 15 μm.

17. The transdermal therapeutic system as claimed in claim 3, wherein the at least one opening has an area from 0.19 to 78.54 mm.sup.2.

18. The transdermal therapeutic system as claimed in claim 3, wherein the at least one opening has an area from 0.78 to 19.64 mm.sup.2.

19. The transdermal therapeutic system as claimed in claim 8, wherein the synthetic rubbers are styrene-diene copolymers, styrene-butadiene block copolymers, styrene- isoprene block copolymers, acrylonitrile-butadiene rubber, butyl rubber or neoprene rubber.

20. The transdermal therapeutic system as claimed in claim 10 , wherein the solubilizers are polyhydric alcohols and the concentration of the solubilizer(s) is between 5% and 35% by weight, based on the entire system.

21. The transdermal therapeutic system as claimed in claim 10 , wherein the solubilizers are selected from the group consisting of propane-1,2-diol, butanediols, glycerol, polyethylene glycol 400, tetrahydrofurfuryl alcohol, diethylene glycol monoethyl ether, diethyl toluamide, and monoisopropylidene glycerol.

22. The transdermal therapeutic system as claimed in claim 12, wherein the synthetic rubbers are styrene-diene copolymers, styrene-butadiene block copolymers, isoprene block copolymers, acrylonitrile-butadiene rubber, butyl rubber or neoprene rubber.

23. The transdermal therapeutic system as claimed in claim 13, wherein the fiber material is a woven or nonwoven fabric comprised of cotton and said fiber material is embedded in a plastic matrix or synthetic resin matrix.

Description

[0041] FIG. 1 shows a schematic representation of a TTS according to the invention.

[0042] FIG. 2 shows a lateral view of a TTS according to the invention. FIGS. 1 and 2 show a backing layer (4) impermeable to the active substance, an active substance reservoir (2) comprising at least one active substance, a skin-facing barrier layer (3), and an opening (1).