Iontophoretic delivery device and method of hydrating same

• US 5,385,543 A
• Filed: 06/30/1993
• Issued: 01/31/1995
• Est. Priority Date: 10/29/1990
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gyory, J. Richard, Theeuwes, Felix, Haak, Ronald P., Myers, Robert M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US08/085,466
• Time in Patent Office: 580 Days
• Field of Search: 604/20, 604/49, 607/149, 607/151
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A dry-state iontophoretic drug delivery device (10, 20) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a passageway (21, 22) is provided through the backing layer (13) and the electrode layer (11, 12) of both the donor electrode assembly (8) and the counter electrode assembly (9). Water or other liquid can be introduced through these passageways (21, 22) in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10). In another embodiment of the device (20), the drug and electrolyte reservoirs (15, 16) are initially separated from their respective electrodes (11, 12). After the reservoirs (15, 16) are hydrated, they are placed in electrical contact with their respective electrodes (11, 12). By joining the reservoir (15, 16) to the electrode (11, 12) after hydration occurs, delamination problems are reduced.

Claims

1. A multilaminate dry state electrode assembly for an electrically powered iontophoretic agent delivery device including a source of electrical power which is electrically connected to the electrode assembly, the electrode assembly including:

a) a reservoir layer including a substantially non-hydrated hydratable matrix containing an agent to be delivered through a body surface;

b) an electrode layer in electrical contact with both the reservoir layer and the power source;

c) means for hydrating the substantially non-hydrated agent containing matrix, said means including a preformed sealable passageway through the electrode layer, the passageway when unsealed establishing fluid communication between the exterior of the device and the matrix, said means enabling a liquid from an external source to be introduced through the passageway and into the reservoir matrix in order to hydrate the matrix and activate the electrode assembly; and

d) means for sealing the passageway after introducing the liquid therein.

3. The electrode assembly of claim 1 or 2, wherein the agent is unstable or becomes degraded in the presence the liquid.

4. The electrode assembly of claim 1 or 2, wherein the electrode assembly is a donor electrode assembly and the agent is a drug.

5. The electrode assembly of claim 4, wherein the liquid comprises water.

6. The device of claim 1 or 2, wherein the electrode assembly is a counter electrode assembly and the agent is an electrolyte.

7. The device of claim 6, wherein the electrolyte is a water soluble electrolyte salt.

8. The device of claim 7, wherein the liquid comprises water.

9. The device of claim 7, wherein the liquid comprises an aqueous solution or an aqueous suspension of the electrolyte.

10. The device of claim 1 or 2, wherein the multilaminate electrode assembly includes an ion-conducting adhesive layer adapted to secure the electrode assembly to the body surface.

11. The device of claim 1 or 2, wherein the multilaminate electrode assembly includes a semipermeable membrane layer positioned between the reservoir layer and the body surface.

12. The device of claim 1 or 2, wherein the reservoir layer is comprised of a hydrophilic polymer.

13. The device of claim 1 or 2, wherein the matrix comprises a mixture of a hydrophilic polymer and a hydrophobic polymer.

14. The device of claim 1 or 2, wherein the power source comprises a battery.

15. The device of claim 1 or 2, wherein the body surface is intact skin or a mucosal membrane.

16. The device of claim 1, including a sealing cover layer formed on the outside of the electrode assembly, the passageway extending through both the electrode layer and the sealing cover layer.

17. The device of claim 1, wherein the preformed passageway contains a liquid wicking material.

18. The device of claim 1, including a layer of a liquid wicking material positioned adjacent the reservoir layer, the passageway extending from the exterior of the device, through the electrode layer to the liquid wicking material layer.

19. The device of claim 1, wherein the reservoir layer has a plurality of grooves in fluid communication with the passageway, said grooves being adapted to convey the liquid introduced through the passageway across the reservoir layer.

20. The electrode assembly of claim 1, wherein the means for sealing the passageway forms a water-tight seal.

21. The electrode assembly of claim 20, wherein the means for sealing the passageway comprises a plug.

28. The device of claim 20, further comprising an ion-impermeable separator positioned between the electrode assemblies, wherein the separator is comprised of hydrophobic polymer.

2. A multilaminate dry state electrode assembly for an electrically powered iontophoretic agent delivery device, the electrode assembly having a reservoir layer containing an agent to be delivered through a body surface and an electrode layer adapted to be place in electrical contact with both the reservoir layer and a power source, the reservoir layer comprising a substantially non-hydrated, hydratable matrix which is initially isolated from the power source, the reservoir layer having an exposable surface for introducing a liquid thereto to hydrate the reservoir layer, the reservoir layer being adapted to be placed in electrical contact with the power source after hydration of the reservoir layer,

wherein both the power source and the reservoir layer are positioned on a sheet in spaced apart relation, the reservoir layer being releasably attached to the sheet.

22. The device of claim 2, wherein the reservoir layer is comprised of a liquid-swellable material.

23. The device of claim 2, wherein the sheet is adapted to be severed intermediate the power source and the reservoir layer.

24. The device of claim 2, wherein the reservoir layer is intermediate the sheet and a release liner.

25. The device of claim 2, wherein the sheet comprises a water impermeable backing material.

26. The device of claim 2, wherein the sheet has a weakened score line between the agent reservoir layer and the electrode layer.

27. An electrically powered iontophoretic agent delivery device comprising:

a) a source of electrical power;

b) a multilaminate dry state donor electrode assembly having a reservoir containing a drug to be delivered through a body surface and a donor electrode in electrical contact with both the drug reservoir and the power source;

c) a multilaminate dry state counter electrode assembly having a reservoir containing an electrolyte and an electrode in electrical contact with the electrolyte reservoir and the power source;

wherein each of the drug reservoir and the electrolyte reservoir comprises a substantially non-hydrated, hydratable matrix which is positioned on a sheet in spaced apart relation to the power source, each of the drug reservoir and electrolyte reservoir having an exposable surface for introducing a hydrating liquid water thereto to hydrate same, the drug reservoir being adapted to be placed in electrical contact with the donor electrode and the electrolyte reservoir being adapted to be placed in electrical contact with the counter electrode after hydration of said reservoirs.

29. A method of hydrating a dry state multilaminate electrode assembly in an electrically powered iontophoretic agent delivery device, the electrode assembly including a substantially non-hydrated hydratable reservoir layer containing an agent to be delivered and an electrode layer in electrical contact with both a power source and the reservoir layer, the method comprising:

introducing a liquid from an external source through a preformed sealable passageway, the passageway when unsealed extending from the exterior of the device through the electrode layer and into the hydratable reservoir layer; and

sealing the passageway after introducing the liquid therein.

31. The method of claim 29 or 30, wherein the agent is unstable or becomes degraded in the presence of the liquid.

32. The method of claim 29 or 30, wherein the electrode assembly is a donor electrode assembly and the agent is a drug.

33. The method of claim 29 or 30, wherein the liquid comprises water.

34. The method of claim 29 or 30, wherein the electrode assembly is a counter electrode assembly and the agent is an electrolyte.

35. The method of claim 34, wherein the electrolyte comprises a water soluble electrolyte salt.

36. The method of claim 29 or 30, wherein the liquid comprises water.

37. The method of claim 29 or 30, wherein the liquid is an aqueous solution or an aqueous suspension of an electrolyte.

38. The method of claim 29 or 30, wherein the reservoir layer is comprised of a non-hydrated hydrogel.

39. The method of claim 29 or 30, wherein the body surface is intact skin or a mucosal membrane.

40. The method of claim 29, including positioning a wicking layer in fluid communication with both the preformed passageway and the agent reservoir, the wicking layer being effective to distribute the liquid introduced through the passageway across a surface of the reservoir layer.

41. The method of claim 29, including providing a plurality of grooves in a surface of the reservoir layer, the grooves being in fluid communication with the preformed passageway, the grooves being effective to distribute the liquid introduced through the passageway across the reservoir layer.

42. The method of claim 29, wherein the sealing forms a water-tight seal.

43. The method of claim 29, including placing a plug in the passageway.

30. A method of hydrating a dry state multilaminate electrode assembly in an electrically powered iontophoretic agent delivery device, the electrode assembly including a non-hydrated hydratable reservoir layer containing an agent to be delivered and an electrode layer adapted to be placed in electrical contact with both the reservoir layer and an electrical power source, the method comprising:

a) positioning the agent containing reservoir layer and the power source on a sheet in spaced apart relation while the agent containing reservoir layer is in a substantially non-hydrated condition, the reservoir layer being releasably attached to the sheet;

b) introducing a hydrating liquid into the reservoir layer in an amount sufficient to permit ion transport through the reservoir layer; and

thereafter

c) electrically connecting the hydrated reservoir layer to the power source.

44. The method of claim 30, including positioning a wicking layer in fluid communication with the agent reservoir layer

45. The method of claim 30, including providing grooves in an accessible surface of the reservoir layer.