Kit, device and method for controlled delivery of oxidizing agent into the skin

• US 20040267190A1
• Filed: 06/02/2004
• Published: 12/30/2004
• Est. Priority Date: 06/02/2003
• Status: Active Grant

• Current Assignee: Power Paper Ltd. (Products To Go, Inc.)
• Original Assignee: Power Paper Ltd. (Products To Go, Inc.)
• Inventors: Gross, Yossi, Nitzan, Zvi, Tamarkin, Dov, Mavor, Daniela, Arbel, Giora, Luski, Shalom, Harel, Nurit
• Granted Patent: US 7,340,297 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/12 Keratolytics, e.g. wart or anti-corn preparations
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A kit, device and method for delivering an oxidizing agent onto and/or into the body are disclosed. Moreover, a dermal patch device, which delivers an oxidizing agent using iontophoresis and or electroosmosis onto and/or into the body is disclosed. Furthermore, use of a dermal patch device for treatment of a body area with an oxidizing agent is disclosed. The device may be a thin and flexible dermal patch. A method of using such a device/kit for treatment of a disorder of a body area with an oxidizing agent is also disclosed.

Claims

1. A kit, comprising:

a formulation comprising an oxidizing agent and/or an oxidizing agent precursor; and

an electrically powered patch to promote delivery of the oxidizing agent and/or the oxidizing agent precursor into a body area.

2. The kit of claim 1, wherein the patch is an iontophoretic patch.

3. The kit of claim 1, wherein the patch comprises:

a first electrode;

a second electrode; and

a power supply to supply electrical energy to the first electrode and the second electrode, wherein the power supply is supported on a base member.

4. The kit of claim 3, wherein the power supply comprises at least one electrochemical cell.

5. The kit of claim 4, wherein the electrochemical cell is thin and flexible.

6. The kit of claim 5, wherein the electrochemical cell is up to 1 mm thick.

7. The kit of claim 3, wherein the first electrode is an anode and the second electrode is a cathode.

8. The kit of claim 4, wherein the electrochemical cell comprises:

a first layer of insoluble negative pole;

a second layer of insoluble positive pole; and

a third layer of aqueous electrolyte disposed between the first and second layers and including;

a deliquescent material to keep the electrochemical cell wet at all times;

an electroactive soluble material to obtain ionic conductivity; and

a water-soluble polymer to obtain a desired viscosity to adhere the first and second layers to the third layer.

9. The kit of claim 4, wherein the electrochemical cell has open architecture.

10. The kit of claim 7, wherein the patch comprises an active electrode, and the active electrode is the anode, the cathode or both the anode and the cathode.

11. The kit of claim 1, wherein the oxidizing agent is selected from the group consisting of an oxidizing agent, an oxidizing agent produced in situ from a precursor, an oxidizing agent produced from an electrochemical reaction and a combination thereof.

12. The kit of claim 1, wherein the oxidizing agent is comprised of a plurality of oxidizing agents.

13. The kit of claim 1, wherein the oxidizing agent is one oxidizing agent.

14. The kit of claim 10, wherein the oxidizing agent is disposed on the active electrode.

15. The kit of claim 1 further comprising a holding component that holds and stores the oxidizing agent formulation to contact a first region of the body area and the active electrode.

16. The kit of claim 15, wherein the holding component comprises a material having a semi-solid form.

17. The kit of claim 15, wherein the holding component is selected from the group consisting of a sponge, separator, non-woven material or substrate base layer.

18. The kit of claim 1, wherein the oxidizing agent or oxidizing agent precursor is applied directly to the body area.

19. The kit of claim 3, wherein the oxidizing agent or oxidizing agent precursor is disposed in an interface area between the first electrode and the second electrode.

20. The kit of claim 1, further comprising:

a conductive layer comprising a conductive composition to provide a conductive layer between the patch and the body area.

21. The kit of claim 20, wherein the conductive composition is a conductive adhesive.

22. The kit of claim 21, wherein the conductive adhesive is a hydrogel.

23. The kit of claim 20, wherein the oxidizing agent is contained in the conductive composition.

24. The kit of claim 20, wherein the patch comprises an active electrode and a counter electrode, and the conductive layer is disposed on the active electrode.

25. The kit of claim 20, wherein the patch further comprises an additional conductive layer disposed on the counter electrode.

26. The kit of claim 1, wherein the body area is selected from the group consisting of skin, teeth, nails, hair, non-malignant growth, tumor and a combination thereof.

27. The kit of claim 1 for treatment of a disorder, wherein the disorder is selected from the group consisting of a bacterial infection, a viral infection, a fungal infection, a mucosal disorder, scaling diseases, tumors, body area discoloration and a combination thereof.

28. The kit of claim 1, wherein the patch is thin and flexible.

29. The kit of claim 3, wherein the power supply comprises a plurality of electrochemical cells.

30. The kit of claim 3, wherein the first electrode and the second electrode is made of a conductive material selected from the group consisting of silver, silver chloride, graphite, zinc, platinum, copper, carbon, or a combination thereof.

31. The kit of claim 3, wherein the first electrode and the second electrode are printed electrodes.

32. The kit of claim 1, wherein the patch is a printed patch.

33. The kit of claim 1, further comprising an additional active medicinal ingredient.

34. A device comprising:

a first electrode adapted to communicate an active substance into a body area by application of an electrical current on a body surface adjacent to the body area;

a second electrode, facilitating closing of electrical circuit with the body surface;

a power source to provide a current and voltage, connected through a conductive media to the first and second electrode; and

an oxidizing agent or an oxidizing agent precursor.

35. The device of claim 34, further comprising a holding component for holding the oxidizing agent or the oxidizing agent precursor.

36. The device of claim 34, wherein the oxidizing agent or oxidizing agent precursor is mixed within the material of one or both of the first and the second electrodes.

37. The device of claim 34, wherein the oxidizing agent or oxidizing agent precursor is disposed in an area between the first electrode and the second electrode.

38. The device of claim 34, wherein the electrical voltage and current facilitate conversion of the oxidizing agent precursor into an oxidizing agent.

39. The device of claim 34, wherein the electrical voltage and current facilitate delivering the oxidizing agent, topically or via iontophoresis, to the body surface.

40. The device of claim 35, further comprising a conductive layer comprising a conductive composition disposed between the patch and the body area, for providing a conductive interfacing layer between the patch and the body area, wherein the conductive layer is disposed on at least one of the group selected from the first electrode, the second electrode and the first and the second electrode, the holding component, the body area surface and a combination thereof.

41. The device of claim 34, wherein the power supply comprises at least one thin and flexible electrochemical cell.

42. The device of claim 34, wherein the patch is thin and flexible.

43. The device of claim 34, wherein the patch is a printed patch.

44. The device of claim 40, wherein the conductive composition comprises the oxidizing agent or the oxidizing agent precursor.

45. The device of claim 34, further comprising a substrate base layer.

46. A method comprising:

converting electrically an oxidizing agent precursor into an oxidizing agent; and

delivering iontophoretically the oxidizing agent, facilitating oxidizing agent penetration of the body area surface and underlying tissues.

47. A method comprising:

providing a device for treatment of a disorder comprising a flexible, wearable patch conformable to the contour of a body area surface and comprising;

a first electrode adapted to communicate an active substance into a body area by application of an electrical current on the body area surface;

a second electrode, facilitating closing of electrical circuit with the body area surface;

a power source for providing a current and voltage, connected through a conductive media to the first and second electrode; and

an oxidizing agent or an oxidizing agent precursor for treatment of a disorder;

contacting the body area with the device for a time period wherein the device promotes oxidizing agent penetration of the body area surface and underlying tissues;

penetrating of the oxidizing agent into and/or onto the body area to treat the body area disorder; and

removing the device from the body area.