Transdermal therapeutic system, its use and production process

• US 6,139,868 A
• Filed: 06/06/1995
• Issued: 10/31/2000
• Est. Priority Date: 08/28/1986
• Status: Expired due to Term

• Current Assignee: LTS Lohmann Therapie-Systeme AG
• Original Assignee: LTS Lohmann Therapie-Systeme AG
• Inventors: Hoffmann, Annegrete
• Primary Examiner(s): Dees, Jose' G.
• Assistant Examiner(s): Shelborne, Kathryne E.
• Application Number:
  US08/466,213
• Time in Patent Office: 1,974 Days
• Field of Search: 424/448, 424/449
• US Class Current: 424/449
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches

Abstract

A therapeutic system for supplying active substances to the skin consists of a backing layer remote from the skin, with at least one active substance depot. The depot may consist of a fluid active substance or a fluid composition comprising an active substance delivery control matrix. There is also included an adhesive fixing device for fixing the therapeutic system on the skin. The therapeutic system is characterized in that the active substance depots (14) consist of at least one adjuvant having a supporting and distributing function by being provided with a planar textile material completely surrounded by matrix (12).

Claims

1. A planar therapeutic system for supplying an active substance to the skin of a user;

said system being free from a control membrane and comprising;

a backing layer remote from the skin;

one or more active substance depots comprising an active substance which is a fluid and an inert fabric adjuvant of fibrous material;

an active substance reservoir adhesive composition matrix completely surrounding the depot; and

a pressure sensitive adhesive fixing device for fixing the therapeutic system on the skin.

2. Therapeutic system according to claim 1, characterized in that the system is at least partly built up in layer form.

3. Therapeutic system claim 1, characterized in that the reservoir matrix is pressure sensitive adhesive.

4. Therapeutic system according to claim 1, characterized in that the reservoir matrix or one or more reservoir matrix layers are provided on at least one side with a pressure-sensitive adhesive coating.

5. Therapeutic system according to claim 3, characterized in that it is to be fixed on the skin also by the reservoir matrix.

6. Therapeutic system according to claim 5, characterized in that the fabric material is in planar form in a woven or non-woven fabric.

7. Therapeutic system according to claim 5, wherein the system is at least partly built up in layer form and the reservoir matrix comprises fluid at least one active substance depot between a backing side reservoir matrix layer and a skin side reservoir matrix layer.

8. Therapeutic system according to claim 7, characterized in that it has a detachable protective layer for the surfaces of the therapeutic system facing the skin and which must be removed prior to application.

9. Process for producing a therapeutic system according to claim 1, characterized in that during the production of the therapeutic system, the active substance depot is produced in situ by combining depot components.

10. Process for producing a therapeutic system according to claim 7, characterized in that the reservoir matrix is formed from at least two reservoir matrix layers, which can be the same or different and between which is introduced the active substance depot.

11. Process according to claim 10, characterized in that the reservoir matrix layers are joined by applying pressure or heat or pressure and heat.

12. Process for producing a therapeutic system according to claim 9, characterized in that the depot is introduced into the reservoir matrix by pressure application.

13. The process according to claim 12, wherein the method of pressure application comprises injecting the depot into the matrix.

14. Process according to claim 10, characterized in that a laminated reservoir matrix is produced, whose skin side top layers have pressure sensitive adhesive characteristics.

15. Process according to claim 9, characterized in that the backing layer and reservoir matrix are joined by pressure or heat or pressure and heat.

16. Process according to claim 10, characterized in that at least part of the matrix layers is formed from solution.

17. Process according to claim 10, characterized in that at least part of the matrix layers is formed from dispersion.

18. Process according to claim 10, characterized in that at least part of the matrix layers is formed from melt.

19. Process according to claim 10, characterized in that at least part of the matrix layers is produced by strewing on particles of the active substance.

32. The therapeutic system according to claim 1, wherein the fabric material is a fibrous viscose/cotton material.

20. A planar therapeutic system for supplying nicotine to the skin of a user;

said system being free from a control membrane and comprising;

a backing layer remote from the skin;

one or more nicotine depots comprising nicotine;

a nicotine reservoir adhesive composition matrix completely surrounding the depot; and

a pressure sensitive adhesive fixing device for fixing the therapeutic system on the skin.

21. Therapeutic system according to claim 20, characterized in that the nicotine depot is present in liquid form.

25. Therapeutic system according to claim 20, characterized in that the reservoir matrix comprises at least two layers, the skin side top layer having pressure sensitive properties.

26. Therapeutic system according to claim 25, wherein the thickness ratio of the reservoir matrix layers X and Y is in the range from 1:

1 to 1;

20.

22. A planar therapeutic system for supplying an active substance to the skin of a user, said system being free from a control membrane and compromising;

a backing layer remote from the skin;

one or more active substance depots comprising a fluid active substance and an inert fabric adjuvant of fibrous material for facilitating processing of active substance; and

an active substance reservoir adhesive composition matrix separating the depot from the skin side.

23. The therapeutic system according to claim 22, characterized in that an active substance is nicotine.

24. Therapeutic system according to claim 22, characterized in that the system is at least partly built up in layer form.

27. Therapeutic system according to claim 24, wherein the reservoir matrix comprises at least two layers and the thickness ratio of the reservoir matrix layers X and Y is in the range of from 1:

1 to 1;

5.

28. The system of claim 22, wherein the therapeutic system is fixed on the skin by a pressure sensitive adhesive reservoir matrix.

29. The system of claim 28, wherein the therapeutic system is fixed to the skin by a pressure-sensitive adhesive.

33. The therapeutic system according to claim 22, wherein the fabric material is present in non-woven form.

34. Therapeutic system according to claim 22, wherein the actiove substance is a fluid composition of a sexual hormone.

35. Therapeutic system according to claim 34, wherein the sexual hormone is progesterone.

30. A planar therapeutic system for supplying nicotine to the skin of a user;

said system being free from a control membrane and comprising;

a backing layer remote from the skin;

one or more nicotine depots comprising fluid nicotine and an inert fabric adjuvant of fibrous material for facilitating processing of nicotine;

a nicotine reservoir adhesive composition matrix completely surrounding the depot; and

a pressure sensitive adhesive fixing device for fixing the therapeutic system on the skin.

31. The process of using a planar therapeutic system by applying it to skin, where the system comprises

a backing layer remote from the skin;

one or more active substance depots comprising an active substance which is a fluid and an inert fabric adjuvant of fibrous material;

an active substance reservoir matrix completely surrounding the depot; and

a pressure sensitive adhesive fixing device for fixing the therapeutic system on the skin,

to which process the active substance is applied systemically transdermally in humans in veterinary medicine or in cosmetics.