US5983130A
Expired / Lapsed
US
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Electrotransport agent delivery method and apparatus
Assignee: Alza Corp
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Filing: 1995-06-07
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Granted: 1999-11-09
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Expires: 2015-06-07
Abstract
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 I max , I max being greater than a critical current density level I c 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.
Inventors
- 👤 J. Bradley Phipps
- 👤 Gary A. Lattin
- 👤 Ronald P. Haak
- 👤 Suneel Gupta
- 👤 Felix Theeuwes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 16:11
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/32; A61N1/325; A61N1/02; A61N1/04; A61N1/0404; A61N1/0408; A61N1/0428; A61N1/0432; A61N1/044; A61N1/0448
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
164 words
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, I max , I max being greater than a critical current density level, I c , 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.
Claim 2
Dependent Claim
164 words
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, I max , I max being greater than a critical current density level, I c , 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.
Claim 3
Dependent Claim
41 words
The device of claim 1, wherein the agent delivery efficiency (E) is more stable at current densities above the critical level I c and less stable at current densities below the critical level I c relative to an untreated body surface.
Claim 4
Dependent Claim
34 words
The method of claim 1, wherein the device is adapted to be applied to human skin and the controller controls I max to provide a current density of at least 40 μA/cm 2 .
Claim 5
Dependent Claim
38 words
The device of claim 1, wherein the agent is fentanyl and the controller controls the applied current density to a level in the range of above 40 μA/cm 2 for a period of at least about 10 msec.
Claim 6
Dependent Claim
41 words
The device of claim 1, wherein the agent is goserelin and the device current level provides a current density in the range of at least about 50 to 100 μA/cm 2 applied for a period of at least about 10 msec.
Claim 7
Dependent Claim
11 words
A device according to claim 1 wherein the agent is fentanyl.
Claim 8
Dependent Claim
26 words
The device of claim 6, wherein the controller varies the a duty cycle of the pulsed driving current in order to vary the agent delivery rate.
Claim 9
Dependent Claim
15 words
The device of claim 1, wherein the donor reservoir contains an intentionally added competitive species.
Claim 10
Dependent Claim
19 words
The device of claim 1, whereby the device delivers the agent through the body surface at a reduced rate.
Claim 11
Independent Claim
159 words
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 I max , I max being greater than a critical current density level, I c , 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.
Claim 12
Independent Claim
159 words
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 I max , I max being greater than a critical current density level, I c , 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.
Claim 13
Dependent Claim
19 words
The method of claim 10, wherein the pulsing frequency is in the range of about 0.1 to 10 Hz.
Claim 14
Dependent Claim
20 words
The method of claim 10, wherein the pulsing electrotransport driving current has a duty cycle of less than about 100%.
Claim 15
Independent Claim
72 words
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.
Claim 16
Independent Claim
72 words
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.
Claim 17
Dependent Claim
19 words
The method of claim 1, wherein the pulsing frequency is in the range of about 0.1 to 100 Hz.
Claim 18
Dependent Claim
20 words
The method of claim 1, wherein the pulsing electrotransport driving current has a duty cycle of less than about 100%.
Claim 19
Independent Claim
219 words
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: (a) identifying a critical current density I c , 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 I c and (ii) lower when the agent is delivered at current densities below I c ; (b) identifying a critical time (t c ) 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 I c , through the body surface for at least a sufficient period greater than t c 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.
Claim 20
Independent Claim
219 words
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: (a) identifying a critical current density I c , 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 I c and (ii) lower when the agent is delivered at current densities below I c ; (b) identifying a critical time (t c ) 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 I c , through the body surface for at least a sufficient period greater than t c 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.
Claim 21
Dependent Claim
23 words
The method of claim 16, wherein the body surface comprises human skin and I c is at least about 40 μA/cm 2 .
Claim 22
Dependent Claim
43 words
The method of claim 16, wherein the agent is fentanyl, the body surface is human skin and I c comprises a current density in the range of at least about 40 μA/cm 2 applied for a period of at least about 10 msec.
Claim 23
Dependent Claim
37 words
The method of claim 16, wherein the agent is goserelin and I c comprises a current density in the range of at least about 50 μA/cm 2 applied for a period of at least about 10 msec.
Claim 24
Dependent Claim
35 words
The method of claim 16, wherein the pulsed current has a duty cycle, the method including the step of varying the duty cycle of the pulsed current in order to vary the agent delivery rate.
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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) | 2002-11-08 | 2003-05-10 | 2003-11-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-11-08 | 2007-05-10 | 2007-11-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-11-08 | 2011-05-10 | 2011-11-09 | $7700.00 | Window Closed / Lapsed |