# US 5,344,394 A · Iontophoretic device incorporating an electrotransport adhesive

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- Number: US 5,344,394 A
- Document ID: US5344394A
- Status: Granted
- Kind: A
- Application number: 08/068,500
- Filed: 1993-05-27
- Granted: 1994-09-06
- Earliest claimed: 1989-02-09
- Assignees: Alza Corporation
- Inventors: J. Richard Gyory; Ronald P. Haak; Felix Theeuwes; Patrick J. Lew
- Web page: https://patentgrep.com/patent/US5344394A

## CPC

- C09J 133/06: of esters containing only carbon, hydrogen and oxygen, the oxygen atom being present only as part of the carboxyl radical
- A61K 9/0009: {involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis}
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61N 1/0436: {Material of the electrode}
- C09J 201/00: Adhesives based on unspecified macromolecular compounds
- A61N 1/0496: {characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives}
- C08L 2205/04: containing interpenetrating networks
- C08L 2666/02: Organic macromolecular compounds, natural resins, waxes or and bituminous materials
- C08L 2666/04: Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
- Y10S 524/925: Natural rubber compositions having nonreactive materials, i.e. NRM, other than: carbon, silicon dioxide, glass titanium dioxide, water, hydrocarbon or halohydrocarbon
- Y10S 525/931: Blend of stated incompatibility
- Y10S 525/937: Utility as body contact e.g. implant, contact lens or I.U.D.
- Y10S 525/941: Polymer mixture containing block copolymer is mixed or reacted with chemical treating agent
- C09J: ADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES (preparation of glue or gelatine C09H)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A two phase adhesive matrix for use in an electrically powered iontophoretic delivery device is provided. The adhesive matrix comprises an adhesive hydrophobic polymer phase and about 15 to 60 wt. % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase. The hydrophilic phase forms upon hydration an interconnecting network of aqueous pathways for passage of the agent through the adhesive. The adhesive can be used to adhere an electrode assembly of an iontophoretic delivery device to a body surface such as skin or a mucosal membrane. Alternatively, the adhesive can be used to adhere together two or more elements of an iontophoretic delivery device.

## Claims

### Claim 1

An electrically powered iontophoretic agent delivery device including a donor electrode assembly, a counter electrode assembly and a source of electrical power adapted to be electrically connect to the donor electrode assembly and the counter electrode assembly, the donor electrode assembly including:
a) an agent reservoir containing an agent, the agent reservoir adapted to be placed in agent transmitting relation with a body surface;
b) a donor electrode adapted to be electrically connected to the source of electrical power, the donor electrode being in electrical contact with the agent reservoir; and
c) a two phase adhesive disposed between the agent reservoir and the body surface for adhering the donor electrode assembly to the body surface, the adhesive comprising an adhesive hydrophobic polymer phase and about 15 to 60 wt. % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase, the hydrophilic phase forming upon hydration an interconnecting network of the hydrophilic polymer throughout the matrix, the network providing aqueous pathways for passage of the agent through the matrix.

### Claim 2

An electrically powered iontophoretic agent delivery device including a donor electrode assembly, a counter electrode assembly and a source of electrical power adapted to be electrically connected to the donor electrode assembly and the counter electrode assembly, the donor electrode assembly including:
a) an agent reservoir containing an agent, the agent reservoir adapted to be placed in agent transmitting relation with a body surface;
b) a donor electrode adapted to be electrically connected to the source of electrical power and the agent reservoir; and
c) a two phase adhesive disposed between the agent reservoir and the donor electrode for adhering the donor electrode to the agent reservoir, the adhesive comprising an adhesive hydrophobic polymer phase and about 15 to 60 wt. % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase, the hydrophilic phase forming upon hydration an interconnecting network of the hydrophilic polymer throughout the matrix, the network providing aqueous pathways for passage of the agent through the matrix.

### Claim 3 (depends on 1, 2)

The device of claim 1 or 2, wherein the matrix comprises about 30 to 40 wt. % on a dry weight basis of the hydrophilic polymer.

### Claim 4 (depends on 1, 2)

The device of claim 1 or 2, wherein the adhesive is capable of absorbing about 7 to 80 wt. % water based on the total weight of the adhesive.

### Claim 5 (depends on 1, 2)

The device of claim 1 or 2, wherein the hydrophilic polymer is selected from the group consisting of polyacrylamide, cross-linked dextran, polyvinylalcohol, starch-graft-poly(sodium acrylate-co-acrylamide) polymers, cellulosic derivatives, hydroxypropylmethyl cellulose, low-substituted hydroxypropyl cellulose, cross-linked Na-carboxymethylcellulose, hydrogels, polyhydroxyethyl methacrylate, blends of polyoxyethylene and polyethylene glycols with polyacrylic acid, polyethylene oxides and cross-linked polyvinyl pyrrolidone.

### Claim 6 (depends on 1, 2)

The device of claim 1 or 2, wherein the hydrophilic polymer is in the form of particles having a particle size of up to about 175 .mu.m.

### Claim 7 (depends on 6)

The device of claim 6, wherein the hydrophilic particles have a particle size of up to about 35 .mu.m.

### Claim 8 (depends on 1, 2)

The device of claim 1 or 2, wherein the adhesive exhibits a specific resistance of less than about 0.33 kohm-cm.sup.2 per mil thickness of adhesive.

### Claim 9 (depends on 1, 2)

The device of claim 1 or 2, wherein the hydrophobic polymer is selected from the group consisting of acrylate adhesives and silicone adhesives.

### Claim 10 (depends on 1, 2)

The device of claim 1 or 2, wherein the hydrophobic polymer phase is rendered adhesive by adding thereto a tackifying resin.

### Claim 11 (depends on 10)

The device of claim 10, wherein the hydrophobic polymer is selected from the group consisting of poly(styrene-isoprenestyrene) block copolymers, ethylene vinyl acetate polymers, plasticized and unplasticized polyvinylchloride, natural and synthetic rubbers, C.sub.2 -C.sub.4 polyolefins, polyethylene, polyisoprene, polyisobutylene and polybutadiene.

### Claim 12 (depends on 10)

The device of claim 10, wherein the tackifying resin is selected from the group consisting of fully hydrogenated aromatic hydrocarbon resins, hydrogenated esters and low molecular weight grades of polyisobutylene.

### Claim 13 (depends on 1, 2)

The device of claim 1 or 2, wherein the agent comprises a drug.

### Claim 14 (depends on 13)

The device of claim 13, wherein the drug is a water soluble drug salt.

### Claim 15 (depends on 1, 2)

The device of claim 1 or 2, wherein the agent comprises an electrolyte.

### Claim 16 (depends on 15)

The device of claim 15, wherein the electrolyte is a water soluble electrolyte salt.