Method and Multilayered Device for Controlled Topical Delivery of Therapeutic Agents to the Skin

• US 20080131493A1
• Filed: 12/28/2007
• Published: 06/05/2008
• Est. Priority Date: 01/02/2004
• Status: Abandoned Application

• Current Assignee: NewMedical Technology, Inc.
• Original Assignee: NewMedical Technology, Inc.
• Inventors: Matloub, Haitham
• Application Number:
  US11/965,904
• Publication Number:
  US 20080131493A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 26/0085 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 26/0095 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

A multilayered composite sheet for delivering one or more therapeutic agents to the skin is disclosed. The composite sheet comprises a flexible porous polymer with open cells of a sufficient size for holding a therapeutic agent, an encapsulating agent for encapsulating the flexible porous polymer and therapeutic agent, and an enrobing agent for enrobing the encapsulated flexible porous polymer and therapeutic agent. Additional layers of the flexible porous polymer, therapeutic agent and other materials are added to the first layer which is in contact with the skin. The first layer has particular particle sizes for the flexible porous polymer, open cell size, and therapeutic agent allowing for relatively quick delivery of the therapeutic agent to the skin. Each successive layer placed on top of the first layer has incrementally larger particle sizes of the flexible porous polymer and therapeutic agent providing successively longer delivery times than the first layer.

Claims

1. A delivery device, which is applied to the surface of skin for delivering one or more therapeutic agents to the skin, comprising:

one or more composite sheets, including

a therapeutic agent;

a flexible, porous, encapsulated polymer open cell foam material for holding and releasing the therapeutic agent;

a polymer enrobing material in contact with the skin for holding and releasing the encapsulated polymer foam material including the therapeutic agent for delivery to the skin.

2. The delivery device according to claim 1, wherein there is a first encapsulated therapeutic agent in a first composite sheet.

3. The delivery device according to claim 1, wherein there is a second encapsulated therapeutic agent in a second composite sheet.

4. The delivery device according to claim 1, wherein there is a third encapsulated therapeutic agent in a third composite sheet.

5. The delivery device according to claim 1, wherein the first composite sheet contacts the skin.

6. The delivery device according to claim 1, wherein the second composite sheet contacts the first composite sheet.

7. The delivery device according to claim 1, wherein the third composite sheet contacts the second composite sheet.

8. The delivery device according to claim 1, wherein the porous flexible foam material has particle support sufficient for the therapeutic agent to be retained therein.

9. The delivery device according to claim 1, wherein the porous foam material has open-face pore sizes for holding and releasing the therapeutic agent having a diameter of about 350 to about 1200 microns.

10. The delivery device according to claim 1, wherein the flexible porous polymer foam material is selected from the group consisting of polyurethane, polyvinylacetate, polyvinylalcohol, polyethylene, and silicone.

11. The delivery device according to claim 1, wherein the therapeutic agent and flexible porous polymer is encapsulated by an encapsulating agent.

12. The delivery device according to claim 11, wherein the encapsulating agent is selected from the group consisting of poly(2-hydroxy ethyl methacrylate), poly(N-vinyl pyrrolidone), poly(methyl methacrylate), poly(vinyl alcohol), poly(acrylic acid), polyacrylamide, poly(ethylene-co-vinyl acetate), poly(ethylene glycol), and poly(methacrylic acid).

13. The delivery device according to claim 1, wherein a polymer enrobing material enrobes the encapsulated flexible porous polymer and therapeutic agent.

14. The delivery device according to claim 12, wherein the polymer enrobing material is selected from a group consisting of silicone, ethylene vinyl acetate, and polyurethane elastomers.

15. The delivery device according to claim 1, wherein a plurality of microchannels pass through the polymer enrobing material for holding and releasing a therapeutic agent.

16. The delivery device according to claim 1, wherein a polymer enclosing material encloses the polymer enrobing material containing the encapsulated porous open cell foam material including the therapeutic agent.

17. The delivery device according to claim 1, wherein the particle size of the flexible porous materials have a diameter of about 800 to about 2500 microns.

18. The delivery device according to claim 5, wherein the first composite sheet closest to the skin includes particles of a flexible porous encapsulated polymer foam material having particle sizes ranging from about 800 to about 900 microns.

19. The delivery device according to claim 6, wherein the second composite sheet includes particles of a flexible porous encapsulated polymer foam material having particle sizes ranging from about 900 to about 1400 microns.

20. The delivery device according to claim 7, wherein the third composite sheet includes particles of a flexible porous encapsulated polymer foam material having particle sizes ranging from about 1400 to about 2500 microns.

21. The delivery device according to claim 18, wherein the first composite sheet includes open cell sizes ranging from about 350 to 650 microns.

22. The delivery device according to claim 19, wherein the second composite sheet includes open cell sizes ranging from about 650 to 950 microns.

23. The delivery device according to claim 20, wherein the third composite sheet includes open cell sizes ranging from about 950 to 1500 microns.

24. The delivery device according to claim 1, wherein the delivery device has three layers.

25. The delivery device according to claim 1, wherein the delivery device has two layers.

26. The delivery device according to claim 1, wherein the delivery device has a sufficient amount of layers for containing therapeutic agents for treating the intended disease, dermatological condition, wound, or scar.

27. The delivery device according to claim 1, wherein the therapeutic agent is selected from the group consisting of antibiotics, antioxidants, platelet-derived growth factor, vitamin A, vitamin C, vitamin E, corticosteroids, silver sulphadiazine, polymixin B sulphate, fusidic acids, pirfenedine, interferon, therapeutic oils, plant extracts, animal extracts, pharmaceuticals, vitamins, hormones, antioxidants, emu oil, aloe vera, lavender oil, rosehip oil silver sulphadiazine, polymixin B, fusidic acic and pirfenedine.

28. The delivery device according to claim 1, wherein one or more therapeutic agents can be utilized.