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WO1991011216A1 - Electrode et methode de transfert par iontophorese - Google Patents

Electrode et methode de transfert par iontophorese Download PDF

Info

Publication number
WO1991011216A1
WO1991011216A1 PCT/US1991/000279 US9100279W WO9111216A1 WO 1991011216 A1 WO1991011216 A1 WO 1991011216A1 US 9100279 W US9100279 W US 9100279W WO 9111216 A1 WO9111216 A1 WO 9111216A1
Authority
WO
WIPO (PCT)
Prior art keywords
reservoir
electrode
conductive element
disposed
frame
Prior art date
Application number
PCT/US1991/000279
Other languages
English (en)
Inventor
Robert Steven Hillman
John Michael Pawelchak
Original Assignee
Gensia Pharmaceuticals, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gensia Pharmaceuticals, Inc. filed Critical Gensia Pharmaceuticals, Inc.
Publication of WO1991011216A1 publication Critical patent/WO1991011216A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0448—Drug reservoir

Definitions

  • the present invention relates to transdermal iontophoretic drug delivery, and more particularly, to iontophoresis electrodes and methods for their use.
  • Iontophoresis is the transport of ionized or charged species by application of an electrical current.
  • Transdermal iontophoresis is the transport of an ionic drug into a patient's skin by application of a current through a drug containing electrode placed against the skin.
  • a second electrode termed the return or indiffe ⁇ rent electrode, is also placed against the skin, normally several inches from the first.
  • the current is evoked by applying a potential between the electrodes in either a constant or pulsed DC or AG mode. It carries the ionized drug "through" the stratum corneum into the dermis where the drug diffuses into the capillaries situated near the dermal-epidermal junction, to the systemic circulation.
  • Flux refers to the amount of drug transported across the skin into the circulation per area per unit time. Flux is proportional to the applied electrical potential, the drug concentration and the electrode area. To achieve clinically effective transdermal iontophoretic delivery, the drug must be transported in sufficient quantity under the application of DC currents that do not damage the skin. Generally, the upper limit of current density is taken to be 0.5 mA/cm2. Other limits on available flux include drug solubility, the partition coefficient of drug in the stratum corneum and. the drug's iontophoretic mobility. Various electrodes and iontophoresis devices have been proposed. See, e.g.. U.S. Patent Nos.
  • the present invention provides an electrode for iontophoretic delivery which is capable of delivering pharmacologically effective quantities of drugs within the limits of acceptable current densities and which should be well tolerated by the patient on whom the electrode is used.
  • the present invention is directed to a novel transdermal iontophoresis electrode having optimal flux capability.
  • a drug reservoir is provided in combination with a conductive member of unique design in a compact adhesive electrode.
  • Means are provided for ensuring uniform current distribution and for minimizing undesirable ions.
  • Figure 1 is a top view of an electrode constructed in accordance with the present invention.
  • Figure 2 is a bottom view of the electrode shown in
  • Figure 1 is a cross-sectional view taken along line
  • Figure 4 is a cross-sectional view taken along line
  • FIG 5 is a perspective view of the electrode shown in Figures 1 to 4.
  • a drug-containing electrode is shown as being generally ovular, although many other shapes could be advantageously employed, provided the electrode is conformable to the area of the body where it is to be applied.
  • the electrode includes interiorly disposed drug delivery components and an exterior support framework.
  • the drug delivery coir ⁇ onents include a gel reservoir or pad sandwiched between a conductive strip and an exterior mesh element.
  • the gel reservoir, conductive strip and mesh elements are laterally coextensive to provide uniform current distribution.
  • the surface area of the reservoir may be up to about 10 cm2, but preferably is only as large as required to keep current density below 0.5 amp/cm2, since increased pad area reduces current density, which may be a major factor in pH change, damage to the patient's skin and build up of a drug depot.
  • the preferred reservoir contains about 1 ml volume and has an area of 1.8 cm2.
  • the depth is in a range of 3-10 mm and is preferably about 5 mm.
  • the conductive strip is formed from a silver strip chlorided by an electrode discharge process impregnated mylar. As thus formed, the electrode undergoes an oxidation reduction reaction during iontophoretic delivery whereby silver chloride is produced.
  • This provides a highly uniform silver-silver chloride contact boundary that enhances flux and minimizes skin irritation by counteracting the formation of highly mobile ions such as H+, which not only compete with the ionized drug for available current, but also decrease pH.
  • the mesh element which may be nylon, polyester, cellulose, rayon or other suitable material, helps retain the drug in the gel reservoir during electrode application while allowing substantially unrestricted flow when the electrode is attached to the patient and the mesh element is compressed between the skin and the reservoir.
  • the drug delivery components are encased in a circumferentially arranged support frame comprising a continuous adhesive foam member.
  • the support frame is shown to be generally rectangular in cross-section although other shapes could be employed.
  • the support frame is slightly thinner than the drug delivery components so that when the conductive strip is flush with one side of the frame, the nylon mesh element extends slightly beyond the other side of the frame to ensure contact of the mesh with the patient's skin.
  • the drug delivery elements be slightly larger than the interior of the support frame so as to be retained therein by compressive engagement.
  • an insulative vinyl backing member may be secured to the top of the support frame.
  • a conductive snap connector mounted to and extending through the backing member is a conductive snap connector.
  • the snap is electrically attached to a tongue extending from the conductive strip and is adapted for connection to an external power and control source (not shown) .
  • the indifferent electrode is constructed in accordance with the drug delivery electrode herein described. For ease of identification, the drug and indifferent electrodes may be color coded.
  • a release liner may be removably attached to the bottom of the support frame to help retain the gel during storage and shipping.
  • transdermal iontophoresis delivery electrode and method has been disclosed. While what has been hereinbefore described represents a embodiment of the invention, it will be recognized that other variations are possible, and the invention is not to be limited except as set forth in the claims appended hereto.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Electrode et méthode permettant l'administration transdermique d'un médicament par iontophorèse comprenant une électrode contenant un réservoir destiné au gel ainsi qu'un élément conducteur en argent et chlorure d'argent disposés de façon adjacente et à enclenchement extensible. Un cadre circonférentiel adhésif contient le réservoir ainsi que l'élément conducteur et un connecteur est fixé à celui-ci à un emplacement adjacent au réservoir de façon à permettre le raccordement de l'électrode à une source d'énergie extérieure.
PCT/US1991/000279 1990-01-26 1991-01-14 Electrode et methode de transfert par iontophorese WO1991011216A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47117890A 1990-01-26 1990-01-26
US471,178 1990-01-26

Publications (1)

Publication Number Publication Date
WO1991011216A1 true WO1991011216A1 (fr) 1991-08-08

Family

ID=23870569

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1991/000279 WO1991011216A1 (fr) 1990-01-26 1991-01-14 Electrode et methode de transfert par iontophorese

Country Status (3)

Country Link
AU (1) AU7242091A (fr)
IE (1) IE910234A1 (fr)
WO (1) WO1991011216A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5374241A (en) * 1989-07-21 1994-12-20 Iomed, Inc. Electrodes for iontophoresis
US5395398A (en) * 1993-07-28 1995-03-07 C. R. Bard, Inc. Microelectric apparatus for the antisepsis, promulgation of healing and analgesia of wound and chronic skin ulcers
WO1996009851A1 (fr) * 1994-09-29 1996-04-04 Becton Dickinson And Company Procede de preparation d'electrodes en chlorure d'argent destinees a des dispositifs d'administration de medicaments iontophoretiques
US9079988B2 (en) 2008-10-08 2015-07-14 Borealis Ag Preparation of propylene copolymer with dynamically operated reactor

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3977392A (en) * 1975-04-21 1976-08-31 Eastprint, Inc. Medical electrode
US4102331A (en) * 1976-09-21 1978-07-25 Datascope Corporation Device for transmitting electrical energy
US4706680A (en) * 1986-06-30 1987-11-17 Nepera Inc. Conductive adhesive medical electrode assemblies
US4747819A (en) * 1984-10-29 1988-05-31 Medtronic, Inc. Iontophoretic drug delivery
WO1988008729A1 (fr) * 1987-05-15 1988-11-17 Newman Martin H Systeme d'administration de medicament par inophorese iontophorese

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3977392A (en) * 1975-04-21 1976-08-31 Eastprint, Inc. Medical electrode
US4102331A (en) * 1976-09-21 1978-07-25 Datascope Corporation Device for transmitting electrical energy
US4747819A (en) * 1984-10-29 1988-05-31 Medtronic, Inc. Iontophoretic drug delivery
US4706680A (en) * 1986-06-30 1987-11-17 Nepera Inc. Conductive adhesive medical electrode assemblies
WO1988008729A1 (fr) * 1987-05-15 1988-11-17 Newman Martin H Systeme d'administration de medicament par inophorese iontophorese

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5374241A (en) * 1989-07-21 1994-12-20 Iomed, Inc. Electrodes for iontophoresis
US5558632A (en) * 1989-07-21 1996-09-24 Iomed, Inc. Electrodes for iontophoresis
US5395398A (en) * 1993-07-28 1995-03-07 C. R. Bard, Inc. Microelectric apparatus for the antisepsis, promulgation of healing and analgesia of wound and chronic skin ulcers
WO1996009851A1 (fr) * 1994-09-29 1996-04-04 Becton Dickinson And Company Procede de preparation d'electrodes en chlorure d'argent destinees a des dispositifs d'administration de medicaments iontophoretiques
US9079988B2 (en) 2008-10-08 2015-07-14 Borealis Ag Preparation of propylene copolymer with dynamically operated reactor

Also Published As

Publication number Publication date
IE910234A1 (en) 1991-08-14
AU7242091A (en) 1991-08-21

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