US5169383A
Expired / Lapsed
US
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Control membrane for electrotransport drug delivery
Assignee: Alza Corp
•
Filing: 1989-10-02
•
Granted: 1992-12-08
•
Expires: 2009-10-02
Abstract
Abstract A membrane capable of controlling the rate at which an agent is released from an iontophoretic delivery device is provided. The membrane inhibits agent release from the delivery device when no electrical current is flowing and yet provides minimal impedance to electrically-assisted agent delivery. The membrane is useful both as a control membrane in an iontophoretic agent delivery device and as a test membrane for testing the performance characteristics of an iontophoretic agent delivery device in vitro.
Inventors
- 👤 J. Richard Gyory
- 👤 Ronald P. Haak
- 👤 Felix Theeuwes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 17:54
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/20; A61N1/30; A61N1/02; A61N1/04; A61N1/0404; A61N1/0408; A61N1/0428; A61N1/0444; A61N1/0432; A61N1/044
Claims Analysis
Total Claims: 58
Claim 1
Independent Claim
132 words
An iontophoretic agent delivery electrode for placement on a body surface and for delivering an agent through the body surface, comprising: a reservoir containing the agent to be delivered; conductive means for electrically connecting the reservoir to a source of electrical power; a means for maintaining the reservoir in agent transmitting relationship to said body surface; and a membrane interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 2
Dependent Claim
132 words
An iontophoretic agent delivery electrode for placement on a body surface and for delivering an agent through the body surface, comprising: a reservoir containing the agent to be delivered; conductive means for electrically connecting the reservoir to a source of electrical power; a means for maintaining the reservoir in agent transmitting relationship to said body surface; and a membrane interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 3
Dependent Claim
20 words
The electrode of claim 1, wherein the body surface is selected from the group consisting of skin and mucosal membranes.
Claim 4
Dependent Claim
11 words
The electrode of claim 1, wherein the agent comprises a drug.
Claim 5
Dependent Claim
19 words
The electrode of claim 1, wherein the agent is selected from the group consisting of peptides, polypeptides and proteins.
Claim 6
Dependent Claim
33 words
The electrode of claim 1, wherein the membranes 11/33 to 12/12 is comprised of a material selected from the group consisting of polycarbonates, polyesters, polyamides, styrene-acrylic acid copolymers, polyurethanes, cellulose ester and polyalkylenes.
Claim 7
Dependent Claim
19 words
The electrode of claim 1, wherein the membrane comprises a mixture of a hydrophilic resin and a hydrophobic polymer.
Claim 8
Dependent Claim
17 words
The electrode of claim 6, wherein the mixture comprises about 10 to 30 vol % hydrophilic resin.
Claim 9
Dependent Claim
11 words
The electrode of claim 6, wherein said hydrophilic resin comprises polyvinylpyrrolidone.
Claim 10
Dependent Claim
14 words
The electrode of claim 6, wherein said hydrophilic resin comprises an ion exchange resin.
Claim 11
Dependent Claim
30 words
The electrode of claim 6, wherein said hydrophobic polymer comprises an ethylene vinyl acetate copolymer having a vinyl acetate content in the range of about 1 to 40 weight percent.
Claim 12
Dependent Claim
162 words
An iontophoretic agent delivery device for placement on a body surface comprising: a donor electrode including a reservoir containing the agent to be delivered, a counter electrode and a source of electrical power electrically connected to the donor and counter electrodes, the donor and counter electrodes adapted to be placed in spaced apart relationship on the body surface; means for maintaining the agent reservoir in agent transmitting relation with the body surface and for maintaining the counter electrode in electrolyte transmitting relation with the body surface; and a membrane interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 13
Dependent Claim
162 words
An iontophoretic agent delivery device for placement on a body surface comprising: a donor electrode including a reservoir containing the agent to be delivered, a counter electrode and a source of electrical power electrically connected to the donor and counter electrodes, the donor and counter electrodes adapted to be placed in spaced apart relationship on the body surface; means for maintaining the agent reservoir in agent transmitting relation with the body surface and for maintaining the counter electrode in electrolyte transmitting relation with the body surface; and a membrane interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 14
Dependent Claim
20 words
The device of claim 11, wherein the body surface is selected from the group consisting of skin and mucosal membranes.
Claim 15
Dependent Claim
11 words
The device of claim 11, wherein the agent comprises a drug.
Claim 16
Dependent Claim
19 words
The device of claim 11, wherein the agent is selected from the group consisting of peptides, polypeptides and proteins.
Claim 17
Dependent Claim
30 words
The device of claim 11, wherein the membrane is comprised of a material selected from the group consisting of polycarbonates, polyesters, polyamides, styrene-acrylic acid copolymers, polyurethanes, cellulose esters and polyalkylenes.
Claim 18
Dependent Claim
19 words
The device of claim 11, wherein the membrane comprises a mixture of a hydrophilic resin and a hydrophobic polymer.
Claim 19
Dependent Claim
17 words
The device of claim 16, wherein the mixture comprises about 10 to 30 vol % hydrophilic resin.
Claim 20
Dependent Claim
11 words
The device of claim 16, wherein the hydrophilic resin comprises polyvinylpyrrolidone.
Claim 21
Dependent Claim
14 words
The device of claim 16, wherein the hydrophilic resin comprises an ion exchange resin.
Claim 22
Dependent Claim
30 words
The device of claim 16, wherein said hydrophobic polymer comprises a ethylene vinyl acetate copolymer having a vinyl acetate content in the range of about 1 to 40 weight percent.
Claim 23
Dependent Claim
131 words
A membrane for controlling agent delivery rom an iontophoretic agent delivery device adapted to deliver the agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir and through the body surface, wherein the membrane is interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 24
Dependent Claim
131 words
A membrane for controlling agent delivery rom an iontophoretic agent delivery device adapted to deliver the agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir and through the body surface, wherein the membrane is interposed between the agent reservoir and the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 1 volt, and a J p of less than about 100 μg/hr-cm 2 .
Claim 25
Dependent Claim
11 words
The membrane for claim 21, wherein the agent comprises a drug.
Claim 26
Dependent Claim
30 words
The membrane of claim 1, wherein the membrane is comprised of a material selected from the group consisting of polycarbonates, polyesters, polyamides, styrene-acrylic acid copolymers, polyurethanes, cellulose esters and polyalkylenes.
Claim 27
Dependent Claim
16 words
The membrane of claim 21, comprising a mixture of a hydrophilic resin and a hydrophobic polymer.
Claim 28
Dependent Claim
17 words
The membrane of claim 24, wherein the mixture comprises about 10 to 30 vol % hydrophilic resin.
Claim 29
Dependent Claim
28 words
The membrane of claim 24, wherein the hydrophilic resin is selected from the group consisting of hydrophilic polymers having an equilibrium water content of at least about 10%.
Claim 30
Dependent Claim
11 words
The membrane of claim 26, wherein said hydrophilic resin comprises polyvinylpyrrolidone.
Claim 31
Dependent Claim
14 words
The membrane of claim 24, wherein said hydrophilic resin comprises an ion exchange resin.
Claim 32
Dependent Claim
29 words
The membrane of claim 28, wherein said ion exchange resin has a functional group selected from the group consisting of sulfonic acid, carboxylic acid, imidodiacetic acid and quaternary amines.
Claim 33
Dependent Claim
27 words
The membrane of claim 24, wherein the hydrophobic polymer is selected from the group consisting of polymers having an equilibrium water content of less than about 10%.
Claim 34
Dependent Claim
30 words
The membrane of claim 24, wherein said hydrophobic polymer comprises an ethylene vinyl acetate copolymer having a vinyl acetate content in the range of about 1 to 40 weight percent.
Claim 35
Dependent Claim
118 words
A membrane for testing performance characteristics of an iontophoretic agent delivery device adapted for delivering an agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir and through the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 10 volts and a J p of less than about 100 μg/hr-cm 2 .
Claim 36
Dependent Claim
118 words
A membrane for testing performance characteristics of an iontophoretic agent delivery device adapted for delivering an agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir and through the body surface, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 10 volts and a J p of less than about 100 μg/hr-cm 2 .
Claim 37
Dependent Claim
11 words
The membrane of claim 32, wherein the agent comprises a drug.
Claim 38
Dependent Claim
33 words
The membrane of claim 32, wherein the membrane 11/33 to 12/12 is comprised of a material selected from the group consisting of polycarbonates, polyesters, polyamides, styrene-acrylic acid copolymers, polyurethanes, cellulose esters and polyalkylenes.
Claim 39
Dependent Claim
16 words
The membrane of claim 32, comprising a mixture of a hydrophilic resin and a hydrophobic polymer.
Claim 40
Dependent Claim
17 words
The membrane of claim 35, wherein the mixture comprises about 10 to 30 vol % hydrophilic resin.
Claim 41
Dependent Claim
28 words
The membrane of claim 35, wherein the hydrophilic resin is selected from the group consisting of hydrophilic polymers having an equilibrium water content of at least about 10%.
Claim 42
Dependent Claim
11 words
The membrane of claim 37, wherein said hydrophilic resin comprises polyvinylpyrrolidone.
Claim 43
Dependent Claim
14 words
The membrane of claim 35, wherein said hydrophilic resin comprises an ion exchange resin.
Claim 44
Dependent Claim
29 words
The membrane of claim 38, wherein said ion exchange resin has a functional group selected from the group consisting of sulfonic acid, carboxylic acid, imidodiacetic acid and quaternary amines.
Claim 45
Dependent Claim
27 words
The membrane of claim 35, wherein the hydrophobic polymer is selected from the group consisting of polymers having an equilibrium water content of less than about 10%.
Claim 46
Dependent Claim
30 words
The membrane of claim 35, wherein the hydrophobic polymer comprises an ethylene vinyl acetate copolymer having a vinyl acetate content in the range of about 1 to 40 weight percent.
Claim 47
Independent Claim
173 words
A method for testing performance characteristics of an iontophoretic agent delivery device adapted for delivering an agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir, comprising: placing the reservoir in agent transmitting relation with one surface of a membrane, the membrane having a second surface opposite the surface which is in agent transmitting relation with the reservoir, which second surface is in contact with an agent collecting medium, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 10 volts, and a J p of less than about 100 μg/hr-cm 2 ; and connecting the source of electrical power to the device and driving the agent through the membrane.
Claim 48
Independent Claim
173 words
A method for testing performance characteristics of an iontophoretic agent delivery device adapted for delivering an agent through an intact body surface, the device having a reservoir containing the agent to be delivered and being connectable to a source of electrical power for driving the agent from the reservoir, comprising: placing the reservoir in agent transmitting relation with one surface of a membrane, the membrane having a second surface opposite the surface which is in agent transmitting relation with the reservoir, which second surface is in contact with an agent collecting medium, the membrane permitting electrically-assisted flux (J EK ) of the agent therethrough and substantially preventing passive flux (J p ) of the agent therethrough, the membrane exhibiting a (J EK +J p )/J p ratio of at least about 4, a voltage drop across the membrane of less than about 10 volts, and a J p of less than about 100 μg/hr-cm 2 ; and connecting the source of electrical power to the device and driving the agent through the membrane.
Claim 49
Dependent Claim
11 words
The method of claim 43, wherein the agent comprises a drug.
Claim 50
Dependent Claim
33 words
The method of claim 43, wherein the membrane 11/33 to 12/12 is comprised of a material selected from the group consisting of polycarbonates, polyesters, polyamides, styrene-acrylic acid copolymers, polyurethanes, cellulose esters and polyalkylenes.
Claim 51
Dependent Claim
19 words
The method of claim 43, wherein the membrane comprises a mixture of a hydrophilic resin and a hydrophobic polymer.
Claim 52
Dependent Claim
17 words
The method of claim 46, wherein the mixture comprises about 10 to 30 vol % hydrophilic resin.
Claim 53
Dependent Claim
27 words
The method of claim 46, wherein the hydrophilic resin is selected from the group consisting of hydrophilic polymers having an equilibrium water content greater than about 10%.
Claim 54
Dependent Claim
11 words
The method of claim 46, wherein said hydrophilic resin is polyvinylpyrrolidone.
Claim 55
Dependent Claim
14 words
The method of claim 46, wherein said hydrophilic resin is an ion exchange resin.
Claim 56
Dependent Claim
29 words
The method of claim 50, wherein said ion exchange resin has a functional group selected from the group consisting of sulfonic acid, carboxylic acid, imidodiacetic acid and quaternary amines.
Claim 57
Dependent Claim
27 words
The method of claim 46, wherein the hydrophobic polymer is selected from the group consisting of polymers having an equilibrium water content of less than about 10%.
Claim 58
Dependent Claim
30 words
The method of claim 46, wherein the hydrophobic polymer comprises an ethylene vinyl acetate copolymer having a vinyl acetate content in the range of about 1 to 40 weight percent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-12-08 | 1996-06-08 | 1996-12-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-12-08 | 2000-06-08 | 2000-12-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-12-08 | 2004-06-08 | 2004-12-08 | $7700.00 | Window Closed / Lapsed |