Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
First Claim
1. An agent-containing reservoir for incorporation into an electrotransport delivery system adapted to be placed in agent-transmitting contact with a subject body surface for delivering the agent through the body surface by means of an electrotransport current (i) applied to the reservoir via a reservoir-contacting electrode, the reservoir being permeable to electrically assisted flux of the agent and having:
- (a) a predetermined volume that holds a quantity of the agent sufficient to achieve therapeutically effective delivery of the agent during the entire intended duration of use, wherein the predetermined volume for a given reservoir thickness is defined by the reservoir average cross-sectional area ARES;
(b) a surface that is placed in contact with the body of the subject during use, the body-contacting surface having an area ABODY that provides at least one of (i) a reservoir/body surface current density IBODY, wherein IBODY=i/ABODY, greater than a minimum current density level above which electrotransport delivery Rate/i is approximately maximal and substantially independent of current density occurring at the body-contacting surface during therapeutic use of the device, and (ii) a drug flux j that is biocompatible; and
(c) a surface in contact with the electrode, the electrode-contacting surface having an area AELECTRODE that provides a reservoir/electrode current density IELECTRODE, wherein IELECTRODE=i/AELECTRODE, that results in at least one of (i) a desired electrochemical reaction along the electrode-contacting surface, and (ii) avoidance of undesired polarization along the electrode-contacting surface.
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Accused Products
Abstract
A reservoir and a family of reservoirs are provided which are designed to be used with a single controller to provide a wide range of therapeutic drug delivering regimens while maintaining many of the same reservoir configurations and drug formulations. A method of making a reservoir and a family of reservoirs and incorporating them into an electrotransport system is disclosed.
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Citations
20 Claims
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1. An agent-containing reservoir for incorporation into an electrotransport delivery system adapted to be placed in agent-transmitting contact with a subject body surface for delivering the agent through the body surface by means of an electrotransport current (i) applied to the reservoir via a reservoir-contacting electrode, the reservoir being permeable to electrically assisted flux of the agent and having:
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(a) a predetermined volume that holds a quantity of the agent sufficient to achieve therapeutically effective delivery of the agent during the entire intended duration of use, wherein the predetermined volume for a given reservoir thickness is defined by the reservoir average cross-sectional area ARES;
(b) a surface that is placed in contact with the body of the subject during use, the body-contacting surface having an area ABODY that provides at least one of (i) a reservoir/body surface current density IBODY, wherein IBODY=i/ABODY, greater than a minimum current density level above which electrotransport delivery Rate/i is approximately maximal and substantially independent of current density occurring at the body-contacting surface during therapeutic use of the device, and (ii) a drug flux j that is biocompatible; and
(c) a surface in contact with the electrode, the electrode-contacting surface having an area AELECTRODE that provides a reservoir/electrode current density IELECTRODE, wherein IELECTRODE=i/AELECTRODE, that results in at least one of (i) a desired electrochemical reaction along the electrode-contacting surface, and (ii) avoidance of undesired polarization along the electrode-contacting surface. - View Dependent Claims (2, 3, 4)
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5. An electrotransport system for delivering an agent through a subject body surface, comprising
a controller for generating and/or controlling an electrotransport current (i) adapted to be separably coupleable to at least two different types of agent-containing reservoirs, one agent-containing reservoir at a time, the at least two different agent containing reservoirs containing distinct amounts of a single therapeutic agent formulation to achieve different dosing levels, the controller applying the electrotransport current (i) to respective reservoirs in the different types of agent-containing reservoirs via a reservoir-contacting electrode, wherein the respective reservoirs in the different types of agent-containing reservoirs each have: -
(a) a predetermined volume that holds a quantity of the agent sufficient to achieve therapeutically effective delivery of the agent during the entire intended duration of use, wherein the predetermined volume, for a given reservoir thickness is defined by the reservoir average cross-sectional area ARES;
(b) a surface that is placed in contact with the body of the subject during use, the body-contacting surface having an area ABODY that provides at least one of (i) a reservoir/body surface current density IBODY, wherein IBODY=i/ABODY, greater than a minimum current density level above which electrotransport delivery Rate/i is approximately maximal and substantially independent of current density occurring at the body-contacting surface during therapeutic use of the device, and (ii) a drug flux j that is biocompatible; and
(c) a surface in contact with the electrode, the electrode-contacting surface having an area AELECTRODE that provides a reservoir/electrode current density IELECTRODE, wherein IELECTRODE=i/AELECTRODE, that results in at least one of (i) a desired electrochemical reaction along the electrode-contacting surface, and (ii) avoidance of undesired polarization along the electrode-contacting surface. wherein ABODY and ARES are different between the distinct agent-containing reservoir types. - View Dependent Claims (6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A set of therapeutic agent-containing reservoirs for use in an electrotransport drug delivery device, each of said reservoirs in the set containing a distinct amount of a single therapeutic agent formulation to achieve different dosing levels, wherein the respective reservoirs in the set each have:
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(a) a predetermined volume that holds a quantity of the agent sufficient to achieve therapeutically effective delivery of the agent during the entire intended duration of use, wherein the predetermined volume for a given reservoir thickness is defined by the reservoir average cross-sectional area ARES;
(b) a surface that is placed in contact with the body of the subject during use, the body-contacting surface having an area ABODY that provides at least one of (i) a reservoir/body surface current density IBODY, wherein IBODY=i/ABODY, greater than a minimum current density level above which electrotransport delivery Rate/i is approximately maximal and substantially independent of current density occurring at the body-contacting surface during therapeutic use of the device, and (ii) a drug flux j that is biocompatible; and
(c) a surface in contact with the electrode, the electrode-contacting surface having an area AELECTRODE that provides a reservoir/electrode current density IELECTRODE, wherein IELECTRODE=i/AELECTRODE, that results in at least one of (i) a desired electrochemical reaction along the electrode-contacting surface, and (ii) avoidance of undesired polarization along the electrode-contacting surface. - View Dependent Claims (18, 19, 20)
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Specification