Programmable apparatus for the transdermal delivery of drugs and method

• US 5,415,629 A
• Filed: 09/15/1993
• Issued: 05/16/1995
• Est. Priority Date: 09/15/1993
• Status: Expired due to Term

• Current Assignee: Medical Ionosonic Technologies, LLP
• Original Assignee: Julian L. Henley
• Inventors: Henley, Julian L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/122,717
• Time in Patent Office: 608 Days
• Field of Search: 604/20, 604/49, 604/21, 607/149-152, 128/639, 128/644, 128/783, 128/798, 128/799, 128/802, 128/803
• US Class Current: 604/20
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/044 Shape of the electrode
• 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
• CPC Class Codes: Y10S 607/90 Substance abuse therapy

Abstract

An apparatus is described for the programmable iontophoretic or iontophoretic-ultrasonic (ionosonic) transdermal delivery of medication across the skin or other biological membrane. In one embodiment, the programmable apparatus controls the depth of penetration of a medicament into the skin. In another embodiment the programmed delivery of medicament is accompanied by an electrical stimulus for treating substance abuse. The apparatus can be adapted for large dermal area application or for a smaller area of application, depending on the choice of specific electrode employed. In a preferred embodiment the apparatus comprises a multichannel iontophoretic applicator electrode. Multiple piezoelectric elements are mounted on the iontophoretic electrode. The combination of ultrasonic vibration and iontophoresis improves the penetration of medicament in contact with the skin or mucous membrane underlying the electrode which can be programmably controlled by a CPU through the use of a EPROM. A wearable embodiment of an ionosonic or iontophoretic drug delivery system employing programmability may be used to produce response conditioning useful for the outpatient treatment of obesity, nicotine detoxification, and narcotic addiction detoxification.

Claims

1. An iontophoretic transdermal medicament applicator comprising in combination:

(a) a medicament carrying layer;

(b) an electrically conductive means electrically connected to said medicament carrying layer, sand electrically conductive means further comprising a plurality of electrode channels wherein each electrode channel is independently electrically driven to iontophoretically drive a medicament from said medicament carrying layer into the skin of a patient;

(c) means for applying a driving voltage to said electrode channels;

(d) programmable means for varying said driving voltage with respect to amplitude, polarity and time

and wherein said programmable means for varying said polarity of said driving voltage is operable for controlling the depth of penetration of a medicament into the skin.

2. The iontophoretic medicament applicator of claim 1 wherein said electrically conductive means further comprises a flexible sheet of substantially electrically non-conductive material with electrically conductive electrode channels supported thereon.

3. The iontophoretic medicament applicator of claim 2 wherein the electrically conductive means comprises a layer of electrically conductive material laminated to a sheet of electrically non-conducting material and wherein a conducting circuit pattern is etched into said conducting layer.

4. The iontophoretic medicament applicator of claim 1 wherein the medicament carrying layer comprises a porous material.

5. The iontophoretic medicament applicator of claim 1 wherein the medicament carrying layer comprises a conductive gel.

6. The iontophoretic medicament applicator of claim 4 wherein said porous material comprises a sponge-like material with vertical cells.

7. The iontophoretic medicament applicator of claim 4 wherein the porous medicament carrying layer comprises an open-celled material selected from the group consisting of polyethylene, paper, cotton, ceramic, silicone rubber and polytetrafluoroethylene.

8. The iontophoretic medicament applicator of claim 1 wherein the polarity, duration and amplitude of said driving voltage applied to said multichannel electrodes by said means for applying said driving voltage are programmable.

9. The ionotophoretic medicament applicator of claim 1 further comprising:

(a) non-programmable means for dosing control; and

(b) second programmable means for measuring the total dosage of said medicament delivered to said patient by said programmable means and non-programmable means to assure that the total daily dose is not exceeded.

10. The iontophoretic medicament applicator of claim 1 further comprising means for the delivery of an electrically generated stimulus to the skin to create a tingling sensation contemporaneously with the delivery of said medicament into said skin of said patient.

11. The iontophoretic medicament applicator of claim 9 wherein said medicament is an anticoagulant.

12. A method for controlling the depth of penetration of an iontophoretically administered medicament into the skin of a patient comprising the steps of:

(a) applying a programmable, pulsed voltage having a first polarity to an iontophoresis electrode, said iontohoresis electrode being in electrical connection with a skin-contacting medicament-contaning layer for a first period of time of sufficient duration to drive at least a portion of said medicament from said medicament-containing layer into said skin until said skin is saturated with medicament; and

(b) reversing said first polarity to stabilize said medicament within said skin for a second period of time of sufficient duration to permit at least partial depletion of said medicament within said skin.