Apparatus for iontophoretic drug delivery

• US 5,006,108 A
• Filed: 11/16/1988
• Issued: 04/09/1991
• Est. Priority Date: 11/16/1988
• Status: Expired due to Term

• Current Assignee: Noven Pharmaceuticals (Hisamitsu Pharmaceutical Company Incorporated)
• Original Assignee: Noven Pharmaceuticals (Hisamitsu Pharmaceutical Company Incorporated)
• Inventors: LaPrade, Ronald E.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US07/271,600
• Time in Patent Office: 874 Days
• Field of Search: 604/20-21, 128/419 R, 128/419 D, 128/421-423, 128/783, 128/741, 128/798, 128/802-803
• 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 1/0444 Membrane
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

An iontophoretic device for delivery of a drug comprising a flexible, non-conductive backing; first and second conductive electrodes composed of a substantially non-ionizing material in a plane, one side of the plane which is optionally attached to the optionally flexible backing, and the other side of the plane which is adapted to be affixed to one side of a flexible and electrically conductive layer containing the drug to be delivered; a source of electrical current and a device for reversing the polarity of the two electrodes. The device can additionally include the conductive layer containing the drug to be delivered, affixed to the plane of the two electrodes. An ion exchange membrane can optionally be disposed between the two electrodes and the drug-containing layer. The device can optionally contain a pulsing device or a current varying device or both to vary the amount of current delivered from time to time or in absolute amount.

Claims

1. An iontophoretic device for delivery of a drug comprising:

a flexible, non-conductive backing layer;

first and second conductive electrodes in a plane composed of a substantially non-ionizing material, attached to one side of which plane is said backing layer and the other side of which plane is adapted to be affixed to one side of a flexible and electrically conductive layer containing drug to be delivered;

a source of electrical current;

means for reversing the polarity of the two electrodes;

a pulse generator means for delivering current to the electrodes in timed intervals;

a switch means for reversing the polarity between electrodes during an intermission period of the therapeutic pulse; and

ion exchange means for separating the electrodes and the conductive layer to inhibit the flow of ions to the electrically conductive layer from the electrode having a charge similar to that of the drug.

2. The device of claim 1, which additionally contains a conductive layer containing the drug to be delivered, affixed to the electrodes.

3. The device of claim 2, wherein the conductive layer is a gel containing a drug in ionic form.

4. The device of claim 1, which additionally contains a conductive layer containing the drug to be delivered, one side of the conductive layer carrying said ion exchange means and the other side attached to the two electrodes.

5. The device of claim 4 in which the conductive layer is a gel.

6. The device of claim 4 in which the drug is contained in karaya gel.

7. An iontophoretic device comprising:

a flexible, non-conductive backing layer;

first and second conductive electrodes in a plane having two sides and composed of a substantially non-ionizing material, one side of which is affixed to the flexible backing layer

a flexible conductive layer containing a drug and affixed to the other side of the electrode;

a source of electrical current;

means for reversing the polarity between the two electrodes during operation;

pulse generator means for delivering current to the electrodes in timed intervals; and

ion exchange means separating the electrodes and the conductive layer to inhibit the flow of ions to the conductive layer from the electrode having a charge similar to that of the drug.

8. The device of claim 7, wherein the conductive layer is a gel containing an ionic drug.

9. A flexible and electrically conductive material adapted and sized to be affixed to a non-conductive backing layer of an iontophoretic device and comprising a flexible layer of a drug in a conductive material, a pressure sensitive adhesive on both sides of said flexible layer, the pressure sensitive adhesive having sufficient adhesive strength to attach to the skin on one side and to an electrode at the other side and an ion exchange means on one side of the pressure sensitive adhesive intermediate the drug layer and the adhesive.