Methods and devices for sustained in-vivo release of an active agent

• US 20060089590A1
• Filed: 09/27/2005
• Published: 04/27/2006
• Est. Priority Date: 10/27/2004
• Status: Abandoned Application

• Current Assignee: Aciont, Inc.
• Original Assignee: Aciont, Inc.
• Inventors: Higuchi, William I., Li, S. Kevin, Mufson, Daniel, Delmage, Michael, Higuchi, John, Tuitupou, Anthony, Koehambilli, Rajan
• Application Number:
  US11/238,104
• Publication Number:
  US 20060089590A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• 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
• CPC Class Codes: A61P 5/38 : of the suprarenal hormones
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The present invention includes methods and devices for providing sustained in-vivo release of an active agent to a subject. In some aspects, such release may be achieved by reacting an active agent in-vivo with a depot forming agent in order to form a sustained release active agent depot inside the subject. The depot can then release the active agent over a sustained period of time.

Claims

1. A device for providing sustained in-vivo release of an active agent in a subject, comprising:

a first electrode assembly configured to contain an active agent; and

a second electrode assembly configured to contain a depot forming agent;

said first and second electrode assemblies having a distance from one another that controls the location of a sustained release depot formed in-vivo when used to deliver the active agent and the depot forming agent to the subject.

2. The device of claim 1, wherein the first electrode assembly and the second electrode assembly are in an integrated single unit.

3. The device of claim 1, wherein the first electrode assembly and the second electrode assembly are configured adjacent one another within the integrated single unit.

4. The device of claim 1, wherein the first and second electrode assemblies have a shape selected from the group consisting of annular, circular, elongated, rectangular, triangular, oblong, or combinations thereof.

5. The device of claim 4, wherein the first and second electrode assemblies are annular.

6. The device of claim 5, wherein the first annular electrode assembly has an inner radius and the second annular electrode assembly is located within the inner radius of the first annular electrode assembly.

7. The device of claim 5, wherein the first electrode assembly includes an annular electrode.

8. The device of claim 5, wherein the second electrode assembly includes an annular electrode.

9. The device of claim 1, wherein the first and second electrode assemblies are separate devices.

10. The device of claim 1, wherein the first and second electrode assemblies are configured to be coupled to an electrical current source.

12. The device of claim 1, wherein the first and second electrode assemblies are functionally coupled to a permselective material.

13. The device of claim 12, wherein the permselective material is a membrane.

14. The device of claim 1, wherein the first electrode assembly is a plurality of first electrode assemblies and the second electrode assembly is a plurality of second electrode assemblies.

15. The device of claim 14, wherein the plurality of first electrode assemblies and the plurality of second electrode assemblies are configured in a concentric orientation.

16. The device of claim 15, wherein the plurality of first electrode assemblies and the plurality of second electrode assemblies are configured to alternate within the concentric orientation.

17. The device of claim 14, wherein each of the plurality of first electrode assemblies is electrically coupled to a separate electrode.

18. The device of claim 14, wherein each of the plurality of second electrode assemblies is electrically coupled to a separate electrode.

19. The device of claim 1, further comprising a third electrode assembly configured to contain the active agent and having an electrode coupled thereto, the third electrode assembly allowing administration of a portion of the active agent that does not form a depot.

20. The device of claim 19, further comprising a return electrode functionally coupled to the third electrode assembly to facilitate the administration of the portion of the active agent that does not form a depot.

21. The device of claim 1, wherein the shape of the device is configured to conform to an eye surface.

22. The device of claim 21, wherein the first and second electrode assemblies are in contact with conjunctiva of the eye.

23. The device of claim 21, wherein a part of the device covers the cornea with the first and second electrode assemblies in contact with conjunctiva.

24. The device of claim 21, wherein a part of the device is extended into a cul-de-sac under eyelids of the eye.

25. The device of claim 1, wherein the first and second electrode assemblies are in contact with skin.

26. The device of claim 1, wherein the first and second electrode assemblies are separated by one or more barriers positioned on an eye surface to preclude the passage of fluid and minimize current flow between the first and second electrode assemblies.

27. The device of claim 26, wherein the one or more barriers forms a seal around the first and second electrode assemblies.

28. The device of claim 27, wherein the one or more barriers is a lip-seal.

29. A method of locating a sustained release depot of an active agent in a subject, comprising:

positioning a first reservoir having a first electrode and containing the active agent on an area of body surface of the subject; and

positioning a second reservoir having a second electrode and containing a depot forming agent on an area of body surface of the subject at an inter-electrode distance from the first electrode that dictates the location of the depot formation within the subject.

30. The method of claim 29, wherein the active agent and the depot forming agent are administered simultaneously.

31. The method of claim 29, wherein the active agent is administered prior to the depot forming agent.

32. The method of claim 29, wherein the active agent is administered after the depot forming agent.

33. The method of claim 29, wherein the inter-electrode distance controls the depth and extent of penetration of the depot.

34. The method of claim 29, wherein the inter-electrode distance is less than about 1 mm.

35. The method of claim 29, wherein the inter-electrode distance is from about 2 mm to about 4 mm.

36. The method of claim 29, wherein the inter-electrode distance is from about 1 mm to about 2 mm.

37. The method of claim 29, wherein the inter-electrode distance is greater than about 4 mm.

38. The method of claim 29, wherein the depot is comprised of the active agent.

39. The method of claim 29, wherein the depot is comprised of a derivative of the active agent.

40. The method of claim 29, wherein the second electrode is the second reservoir.