Electrotransport agent delivery method and apparatus
First Claim
1. In an electrotransport device for delivering a therapeutic agent through a body surface, the delivery device having a source of electrical power, a counter electrode, and a donor reservoir containing the agent, the reservoir having a delivery area through which the agent is delivered through the body surface, the improvement comprising;
- an applied electrotransport current controller, the controller being adapted to apply a pulsating electrotransport current to the reservoir and in turn to the body surface, each pulse of the pulsating current being characterized by a frequency, a duty cycle, a peak width, and a peak current, the peak current when divided by the area of the delivery area providing a peak current density, Imax, Imax being greater than a critical current density level, Ic, above which the body surface exhibits non-transitory higher agent delivery efficiency (E), the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electrotransport current.
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Abstract
An electrotransport agent delivery device for delivering a therapeutic agent through a body surface, and a method for increasing agent delivery efficiency, is provided. The device includes a current controller which delivers a pulsating electrotransport current and peak current density Imax, Imax being greater than a critical current density level Ic above which the body exhibits a non-transitory higher agent delivery efficiency. Methods for increasing electrotransport delivery efficiency (E) of an agent through a body surface by creation of a higher agent delivery efficiency state are also provided.
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Citations
20 Claims
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1. In an electrotransport device for delivering a therapeutic agent through a body surface, the delivery device having a source of electrical power, a counter electrode, and a donor reservoir containing the agent, the reservoir having a delivery area through which the agent is delivered through the body surface, the improvement comprising;
an applied electrotransport current controller, the controller being adapted to apply a pulsating electrotransport current to the reservoir and in turn to the body surface, each pulse of the pulsating current being characterized by a frequency, a duty cycle, a peak width, and a peak current, the peak current when divided by the area of the delivery area providing a peak current density, Imax, Imax being greater than a critical current density level, Ic, above which the body surface exhibits non-transitory higher agent delivery efficiency (E), the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electrotransport current. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 14, 15)
- 10. A method of increasing delivery efficiency (E) of an agent delivered through a body surface by electrotransport, the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electrotransport current, comprising delivering the agent by electrotransport through the body surface by applying a pulsing electrotransport driving current, each pulse of the pulsing driving current having a characteristic maximum peak height, which, when divided by the area of the body surface provides a current density Imax, Imax being greater than a critical current density level, Ic, above which the body surface exhibits higher agent delivery efficiency, the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electrotransport current a frequency and a duty cycle ranging from 1 to 100% wherein the driving current has a pulsing frequency in the range of about 0.1 to 100 Hz.
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13. A method of increasing delivery efficiency (E) of an agent delivered through a body surface by electrotransport, the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electrotransport current, comprising delivering the agent by electrotransport through the body surface by applying a pulsing electrotransport driving current, the driving current having a pulsing frequency in the range of about 0.1 to 100 Hz.
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16. A method of increasing delivery efficiency (E) of an agent delivered through a body surface by electrotransport using a pulsating driving current, the delivery efficiency (E) being equal to the rate of agent delivered through the body surface per unit of applied electric current, the method comprising the steps of:
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(a) identifying a critical current density Ic, which current density is associated with said agent and said body surface, the critical current density being the ratio of peak current divided by drug delivery area, the agent delivery efficiency (E) being (i) higher when the agent is delivered at current densities above Ic and (ii) lower when the agent is delivered at current densities below Ic ; (b) identifying a critical time (tc) of exposure of said body surface to said critical current density; and (c) delivering the agent by electrotransport through the body surface by applying an electrotransport driving current, the driving current having a current density which is above the critical level Ic, through the body surface for at least a sufficient period greater than tc to transform the body surface to an enhanced agent delivery efficiency state which is characterized by said higher efficiency; and (d) delivering agent through the body surface substantially only at said higher efficiency. - View Dependent Claims (17, 18, 19, 20)
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Specification