Device and method for iontophoretic drug delivery

• US 5,558,633 A
• Filed: 12/01/1994
• Issued: 09/24/1996
• Est. Priority Date: 03/30/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Phipps, Joseph B., Holmblad, Carolann, Jevne, Allan H., Howland, Warren W.
• Primary Examiner(s): Zele, Krista M.
• Application Number:
  US08/347,694
• Time in Patent Office: 663 Days
• Field of Search: 607/149, 607/152, 607/153, 604/20, 128/639, 128/640, 128/641
• US Class Current: 604/20
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• 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 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61L 15/60 Liquid-swellable gel-forming materials, e.g. super-absorbents
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: C08L 2666/04 Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 33/26 Homopolymers or copolymers of acrylamide or methacrylamide
• CPC Class Codes: C09J 133/26 Homopolymers or copolymers of acrylamide or methacrylamide

Abstract

An iontophoretic device having a two-layer active electrode element is disclosed. The active element is composed of overlapping skin contact hydrogel and carrier layers. The carrier layer contains dispersed or dissolved active agent. The active electrode element maintains the active agent in stable form and permits efficient transport of the active agent to the host. Also disclosed is an iontophoretic device having a single layer active electrode element. The single layer is a hydrogel as manufactured or substantially dry and capable of being hydrated before use. The skin contact hydrogel of the two-layer active electrode element preferably.

Claims

1. An iontophoretic delivery device, comprising:

a source of current;

an active electrode element in electrical contact with the source of current and adapted to make ion-transmitting contact with a body surface of a host, the active electrode element comprising a single polymer layer adapted to be placed in an ion-transmitting relation with the body surface and which contains an active agent having an electrical charge and being suitable for administration through the body surface of the host, said polymer layer containing an ionic organic polymer component with counter ions, said ionic organic polymer component having at least some pendent substituents having said charge; and

a counter electrode element in electrical contact with the current source and being adapted to be placed in ion-transmitting relation with the body surface.

2. A device according to claim 1 wherein the polymer layer is a hydrogel containing a water-containing, cross-linked or gelled, hydrated, organic polymer component, the polymer having the pendent substituents being ionic.

3. A device according to claim 1 wherein the polymer layer is substantially dry and adapted for being hydrated to a hydrogel.

4. A device according to claim 3 further comprising structure for hydrating the polymer layer with an aqueous medium.

5. A device according to claim 1 wherein:

the ionic organic polymer component is an amphoteric organic polymer; and

the counter ions to the amphoteric organic polymer include first and second groups, the first group being the active agent, and the second group being other ions having a charge opposite that of the active agent.

6. A device according to claim 1 or 2, wherein:

counter ions are present with the ionic organic polymer component; and

at least a portion of the counter ions form, with an electrochemically generated ion generated by the active electrode element, a substance selected from the group consisting of a substantially neutral substance, a substantially insoluble substance and a substantially immobile substance.

7. A device according to claim 1, wherein the ionic organic polymer component is from about 1% to about 100% by weight of the polymers in the polymer layer.

8. An active electrode element for an iontophoretic device suitable for administration of an active agent through a body surface of a host, comprising:

a single polymer layer containing the active agent, the active agent having an electrical charge; and

said polymer layer containing an ionic organic polymer component with counter ions, said ions organic polymer component having at least some pendent groups with said charge.

9. An active electrode element according to claim 8, wherein the polymer layer is hydrogel.

10. An active electrode element according to claim 8, wherein the polymer layer is substantially dry and is adapted for being hydrated to a hydrogel.

11. An active electrode element according to claim 8, 9, or 10, wherein:

the ionic organic polymer component is an amphoteric organic polymer; and

the counter ions to the amphoteric organic polymer include first and second groups, the first group being the active agent, and the second group being other ions having a charge opposite that of the active agent.

12. A device according to claim 8, wherein the ionic organic polymer component is from about 1% to about 100% by weight of the polymers in the polymer layer.

13. An apparatus comprising:

an active electrode element adapted to make ion-transmitting contact with a body surface of a host, the active electrode element comprising a single polymer layer adapted to be placed in an ion-transmitting relation with the body surface and which contains an active agent having an electrical charge, said polymer layer containing an ionic organic polymer component having at least some pendent substituents having said charge.

14. The apparatus of claim 13, further including:

a source of current in electrical contact with the active electrode element.

15. The apparatus of claim 14, further including:

a counter electrode element in electrical contact with the current source.