Methods for iontophoretic delivery of antiviral agents

• US RE37,796 E1
• Filed: 09/01/2000
• Issued: 07/23/2002
• Est. Priority Date: 12/16/1997
• Status: Expired due to Term

• Current Assignee: Nitric Biotherapeutics, Inc.
• Original Assignee: Biophoretic Therapeutic Systems, LLC
• Inventors: Henley, Julian L.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/654,583
• Time in Patent Office: 690 Days
• Field of Search: 601/2, 601/17, 607/154, 607/145, 607/3, 604/19, 604/20, 604/22, 604/49, 604/66, 604/289, 604/290, 604/890.1, 604/500, 604/501
• US Class Current: 604/20
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

A portable iontophoresis apparatus for facilitating delivery of medication across the cutaneous membrane into adjacent underlying tissues and blood vessels. The apparatus employs a modular, detachable non-reusable medicament-containing applicator electrode which is adapted to attach to a base assembly. The apparatus is designed to be hand-held and includes a circumferential tactile electrode band on the base assembly which provides electrical connection between the skin of the user'"'"'s hand and one pole of a bipolar power source housed within the base assembly. The opposing pole of the power source is connected to the applicator electrode. The user'"'"'s body completes the electrical circuit between the applicator and tactile electrodes A method for using the device for the treatment of Herpes simplex infection and related viral infections which produce similar cutaneous lesions is presented. The apparatus, when used in accordance with the method described herein, demonstrated >90% treatment efficacy in clinical trials.

Claims

1. A disposable medicament dispensing applicator electrode for and an iontophoretic drug medicament delivery device adapted for the self-administration of a medicament into a person'"'"'s skin at a localized treatment site, said device comprising a base assembly having an active terminal adapted to receive and make electrical contact with a detachable said medicament dispensing applicator electrode, wherein said base assembly comprises:

a case having an elongate, substantially cylindrical outer surface having a size and shape adapted to be comfortably grasped within a person'"'"'s hand, and wherein at least a portion of said outer surface is a including tactile electrode formed of an electrically conductive material;

, and a bipolar electrical power means having a first pole and a second pole;

, said electrical power means being enclosed within said case and wherein said first pole is being in electrical communication with said tactile electrode;

wherein said medicament dispensing applicator electrode comprises;

including a module containing a unit dose of medicament, an electrically conductive working electrode and means thereon adapted for releasably attaching said applicator electrode to said device in electrical contact with said second pole of said electrical power means, wherein said applicator electrode further comprises comprising an elongate strip constructed of a substantially electrically non-conductive substrate material, said strip having a central portion containing a the medicament in an electrically conductive substrate for iontophoretic delivery of the medicament into the person'"'"'s skin at the treatment site upon completion of an electrical circuit from said power means through said active terminal and said tactile electrode via the person'"'"'s skin at the treatment site, and said strip having laterally symmetric end portions having cutouts therewithin.

2. The disposable medicament dispensing applicator electrode of claim 1 wherein said cutouts in said laterally symmetric end portions contain an electrically conductive material.

3. The disposable medicament dispensing applicator electrode of claim 2 wherein said electrically conductive material is a gel.

4. A disposable medicament dispensing applicator electrode for an iontophoretic drug delivery device adapted for the self-administration of a medicament into a person'"'"'s skin, said device comprising a base assembly having an active terminal adapted to receive and make electrical contact with a detachable medicament dispensing applicator electrode wherein said base assembly comprises;

a case having an elongate, substantially cylindrical outer surface having a size and shape adapted to be comfortably grasped within a person'"'"'s hand and wherein at least a portion of said outer surface is a tactile electrode formed of an electrically conductive material; and

a bipolar electrical power means having a first pole and a second pole;

said electrical power means being enclosed within said case and wherein said first pole is in electrical communication with said tactile electrode;

wherein said medicament dispensing applicator electrode comprises;

a module containing a unit dose of medicament, an electrically conductive working electrode and means thereon adapted for releasably attaching applicator working electrode to said second pole of said electrical power means wherein said applicator electrode further comprises an elongate strip constructed of a substantially electrically non-conductive substrate material, said strip having a central portion containing a medicament in an electrically conductive substrate and said strip having laterally symmetric end portions having cutouts therewithin.

5. A combination disposable medicament dispensing applicator electrode and drug delivery device for electrokinetic self-administration of a medicament into an individual'"'"'s skin at a localized treatment site, said device including a base assembly having an active terminal for receiving and making electrical contact with the medicament dispensing applicator electrode, said base assembly comprising a case including an outer surface having a size and shape for comfortably grasping within an individual'"'"'s hand, a portion of said outer surface including a tactile electrode formed of an electrically conductive material and a bipolar electrical power means having a first pole and a second pole, said electrical power means being enclosed within said case, said first pole being in electrical contact with said tactile electrode, said medicament dispensing applicator electrode comprising an elongated strip containing a medicament, and means for releasably attaching said applicator electrode to said case in electrical contact with said second pole of said electrical power means, said strip being formed of a substantially electrically non-conductive strip material having a portion thereof containing a medicament, said device and said electrode being operable to electrokinetically effect delivery of the medicament in said strip to the individual'"'"'s skin at the treatment site in contact with said substrate in response to completion of an electrical circuit between said second pole through said strip and via the individual'"'"'s contacted skin at the treatment site and said first pole through said tactile electrode when the device is grasped by the individual.

6. A combination according to claim 5 wherein the medicament is charged.

7. A combination according to claim 5 wherein said non-conductive strip material portion contains a conductive gel to facilitate electrokinetic delivery of the medicament into the individual'"'"'s skin at the treatment site.