Programmable apparatus for reducing substance dependency in transdermal drug delivery

• US 5,538,503 A
• Filed: 01/09/1995
• Issued: 07/23/1996
• 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): Green, Randall L.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/370,116
• Time in Patent Office: 561 Days
• Field of Search: 604/20-21, 601/2-3, 607/149-152, 607/900, 607/58
• 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 apparatus for the transdermal delivery of medicament comprising a transdermal drug delivery portion and a stimulating portion, said transdermal drug delivery apparatus comprising:

(a) a substantially planar, skin-contacting medicament carrying layer; and

(b) an electrically conductive means in electrical communication with said medicament carrying layer; and

(c) at least two electrodes including an iontophoresis electrode comprising a planar array of electrode channels, said iontophoresis electrode being substantially coplanar with said medicament containing layer and wherein said electrode channels are in electrical communication with both said medicament containing layer and said electrically conductive means; and

(d) an ultrasonic element providing means operable for producing mechanical vibrations at ultrasonic frequencies in response to the application of a voltage thereto comprising at least one least one piezoelectric element in mechanical communication with said medicament containing layer which ultrasonic element produces ultrasonic compression waves in at least a portion of said skin-contacting medicament carrying layer; and

(e) means for applying a voltage to said at least two electrodes; and

(f) programmable means for controlling said means for applying a voltage to said at least two electrodes;

said programmable means having stored therein a drug delivery portion for controlling the medicament dosage transdermally delivered and a stimulating portion for applying an electrical stimulus to said skin of a patient to produce a sensation upon each activation of said apparatus, said programmable means reducing said medicament dosage over time upon subsequent activations of said apparatus whereby the patients dependency on said medicament is reduced.

2. The apparatus according to claim 1 wherein the electrically conductive means comprises a metallic film selected from the group consisting of copper, platinum, gold or silver.

3. The apparatus according to claim 1 wherein the medicament carrying layer comprises an open-celled, absorbent porous material.

4. The apparatus according to claim 3 wherein the open-celled, absorbent porous material is selected from the group consisting of polyethylene, paper, cotton, silicone, polytetrafluoroethylene and ceramic.

5. An apparatus for the transdermal delivery of medicament comprising a transdermal drug delivery portion and a stimulating portion, said transdermal drug delivery apparatus comprising:

(a) a skin-contacting medicament portion; and

(b) at least two electrodes including an electrode in electrical contact with said medicament portion for delivering drug to the patient; and

(c) means for applying a voltage to said at least two electrodes; and

(d) programmable means for controlling said means for applying a voltage to said at least two electrodes;

said programmable means having stored therein a drug delivery portion for controlling the medicament dosage transdermally delivered to the patient and a stimulating portion for applying an electrical stimulus to said skin of a patient to produce a sensation upon each activation of said apparatus, said programmable means reducing said medicament dosage over time upon subsequent activations of said apparatus whereby the patient'"'"'s dependency on said medicament is reduced.