Alza Corporation

Ronald P Haak

Felix T Theeuwes

J Richard Gyory

Gary A Lattin

Robert M Myers

Suneel K Gupta

Felix A Landrau

John D Badzinski

J Bradley Phipps

Larry A McNichols

Nathan Roth

Patrick J Lew

Lothar W Kleiner

Joseph B Phipps

Harold F Sanders

David K Roe

Richard W Plue

Peter E Daddona

Michel J Cormier

William N Reining

Jane Yieh

Linda M Hearney

Larry A Mc Nichols

Wiliam N Reining

James A Matriano

Robert M Meyers

An electrotransport device for delivering one or more therapeutic agents through the skin includes electrodes for contacting the skin, at least one electrode containing the agent, a power source for generating electrical current (I) for delivering the agent, a current generating and controlling means and a disabling means for permanently and irreversibly disabling the current. The disabling means may include a timer means, a counter means, or a body parameter sensor and limit comparator to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source, or a permanent diversion of electrotransport current from the electrodes, or a combination of the above. The permanent disabling means may include a circuit connection means having a frangible conducting member which permanently fractures and causes an irreversible open circuit in the connection to the electrodes upon removing a disposable/single use electrode assembly from a reusable portion of an electrotransport device.

Electrotransport delivery device having improved safety and reduced abuse potential

A method of increasing the delivery efficiency of an agent through a body surface by electrotransport is disclosed wherein the electrotransport current is applied for durations at a higher current density values followed by durations of lower current density values wherein the higher current density applications transform the body surface to an enhanced, non-transitory agent delivery efficiency state.

Electrotransport agent delivery method and apparatus

An electrotransport agent delivery device () for delivering a therapeutic agent through intact skin, and a method of operating same, is provided. The device applies a pulsing electrotransport current wherein current pulses have a magnitude above a critical level (I) at which the skin is transformed into a higher electrotransport delivery efficiency (E) state. Most preferably the length of the applied current pulses is at least 5 msec and preferably at least 10 msec.

An electrotransport agent delivery device () for delivering a therapeutic agent through intact skin, and a method of operating same, is provided. The device applies a pulsing electrotransport current wherein the length of the applied current pulses is at least 5 msec and preferably at least 10 msec. Most preferably, the current pulses have a magnitude above a critical level (I) at which the skin is transformed into a higher electrotransport delivery efficiency (E) state.

Electrotransport agent delivery apparatus

An electrotransport device () for delivering one or more therapeutic agents through the skin includes electrodes () for contacting the skin (), at least one electrode containing the agent, a power source () for generating electrical current (I) for delivering the agent, a current generating and controlling means (), and a disabling means () for permanently and irreversibly disabling the current. The disabling means () may include a timer means (), a counter means (), or a body parameter sensor () and limit comparator () to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source (), or a permanent diversion of electrotransport current from the electrodes (), or a combination of the above. The permanent disabling means may include a circuit connection means () having a frangible conducting member () which permanently fractures and causes an irreversible open circuit in the connection to the electrodes () upon removing a disposable/single use electrode assembly () from a reusable portion of an electrotransport device.

An electrotransport device and method of operating same provides a pulsed DC current of specified frequency and duration which transforms the skin into a higher electrotransport delivery efficiency state.

An iontophoretic delivery device (,) is provided. Device (,) has an electronic circuit (,) having electronic components such as batteries (,) mounted thereon. Device (,) also includes a pair of electrode assemblies (,). The electronic circuit (,) is electrically connected to the electrode assemblies (,) using an electrically conductive adhesive (,). The adhesive can also be used to electrically connect two or more electronic components within circuit (,) or to connect an electronic component to the electronic circuit (,). In one practice of the invention, the electrically conductive adhesive (,) functions as an electrode and electrically connects the circuit (,) to an agent-containing reservoir (,). In a further practice of the invention, the electrically conductive adhesive (,) functions as an agent reservoir and contains the agent to be iontophoretically delivered.

Iontophoretic drug delivery apparatus

The present invention is an apparatus and method that maintains a constant drug delivery rate for an electrotransport delivery system, while the apparent transport efficiency of the system varies, by making adjustments to the output current of the system. More specifically, the constant drug delivery rate is maintained by the regulator of the electrotransport delivery system automatically adjusting the output current to compensate for the varying apparent transport efficiency.

Programmed adjustment of electric current to provide desired electrically assisted transdermal drug delivery rate

The disclosed invention relates to an improved electrotransport device. The improvement relates to a membrane assembly including a low porosity membrane adhered or sealed to one or two high porosity membranes. The high porosity membranes protect the low porosity membrane from being damaged by components or contaminates on the body surface and/or in the drug reservoir which can lead to undesirable passive flux and/or insufficient iontophoretic flux. As a result, the electrotransport device having the membrane assembly more reliably, precisely, and accurately delivers drug and/or therapeutic agent through the body surface by electrotransport.

Layered rate controlling membranes for use in an electrotransport device

An electrotransport delivery device (410) includes control circuitry for discontinuously delivering a beneficial agent (eg, a drug) through a body surface (eg, skin 400). For example, the device may be the type which is manually activated by the patient or other medical personnel to activate electrotransport drug delivery. Once electrotransport delivery has been activated, a timer (221) counts a transition interval, typically about one minute, during which the device is allowed to operate and the impedance of the body surface (400) is allowed to stabilize. Thereafter, the electrotransport current and voltage are then monitored and compared to predetermined limits. Allowing for the transition interval permits tighter tolerances in monitoring the applied current.

Electrotransport delivery device

A selectively permeable membrane (14) is positioned between the agent reservoir (15) and the electrode (11) of a donor electrode assembly (8) in an iontophoretic delivery device (10). Optionally, an electrolyte reservoir (13) is positioned intermediate the electrode (11) and the agent reservoir (15). In certain embodiments, the membrane (14) is permeable to species of less than a predetermined molecular weight and substantially less permeable to species of greater than the predetermined molecular weight. The agent is capable of dissociating into agent ions and counter ions. The size selectivity of the membrane (14), the molecular weight of the agent ions, the molecular weight of the counter ions, and optionally the molecular weight of the electrolyte ions are selected to (A) inhibit agent ions from interacting with the electrode (11), and from permeating into the electrolyte reservoir (13), where they might otherwise be degraded and (B) inhibit electrolyte ions, having a charge similar to that of the agent ions, from permeating into the agent reservoir (15) and competing with the agent ions for iontophoretic delivery into the patient.

Device and method of iontophoretic drug delivery

A device and method are provided for reducing or preventing skin sensitization in electrotransport drug delivery. The method involves co-administration of a countersensitizing agent, comprising cis-urocanic acid or an analog thereof, with the drug delivered via electrotransport. Novel drug reservoirs and electrotransport drug delivery systems, formulated with a countersensitizing agent as described herein, are provided as well.

Reduction of skin sensitization in electrotransport drug delivery

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.sub.max, I.sub.max being greater than a critical current density level I.sub.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.

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San Jose, CA, United States of America

Ronald P Haak