User activated iontophoretic device and method for activating same

• US 5,738,647 A
• Filed: 09/27/1996
• Issued: 04/14/1998
• Est. Priority Date: 09/27/1996
• Status: Expired due to Term

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: DeNuzzio, John D., Bernhard, Michael I.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): TAO, ELLEN
• Application Number:
  US08/722,813
• Time in Patent Office: 564 Days
• Field of Search: 604/20, 604/21, 607/153
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

A user activated iontophoretic device of the present invention includes an electrode assembly, an electrode reservoir and at least one drug reservoir. The device is divided or otherwise separated into at least two portions, with one portion containing the electrode reservoir and the other containing the drug reservoir, which may include a medication in a dry form. The electrode reservoir and the drug reservoir are sealingly separated by a barrier, which can be removed to bring the reservoirs into fluid conducting contact with one another. A method of activating the device includes causing the two portions to come into fluid conducting contact with one another to at least partially hydrate one of the reservoirs. This can be accomplished by removing the barrier dividing the two portions. In this way, the device is suitable for use to deliver a drug which has limited stability in an aqueous solution.

Claims

1. A user activated iontophoretic device for use in delivering at least one medication through an applied area of a patient, such as the skin, mucus membrane and the like, comprising:

a first portion and a second portion, said first portion including an electrode assembly and a electrode reservoir and said second portion including a drug reservoir;

said electrode assembly including electrode means for driving a medication into the patient to be absorbed by the body of the patient; and

said drug reservoir containing an active compound to be delivered to the applied area of the patient, with the active compound being maintained in a dry state prior to activation of the device;

barrier means for sealingly maintaining said first portion and said second portion separate from one another, with the electrode assembly maintained in electrically communicating relation with the electrode reservoir, and with the active compound contained by the drug reservoir maintained separate in relation to the first portion prior to activation so that upon removal of said barrier means, the electrode reservoir and the drug reservoir are brought into fluid conducting contact with one another so that said drug is dissolved in an aqueous solution contained in said electrode reservoir.

2. A user activated iontophoretic device as defined in claim 1, wherein the electrode reservoir includes an electrolyte in the form of an electrically conductive gel.

3. A user activated iontophoretic device as defined in claim 1, wherein the active compound is selected from the group consisting of cell adhesion molecules, GPIIb/IIa receptor antagonists for the treatment of various thromboembolic disorders.

4. A user activated iontophoretic device as defined in claim 1, wherein said barrier means includes an upper release member and a lower release member so that manipulation of said barrier means brings the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

5. A user activated iontophoretic device as defined in claim 4, wherein said upper release member and said lower release member are interconnected by a pull tab member extending from the first portion and the second portion so that upon pulling the tab member to at least partially remove the barrier from therebetween, the electrode reservoir and the drug reservoir are brought into contact with one another.

6. A user activated iontophoretic device as defined in claim 1, wherein said first portion includes a compartment for at least containing the electrode reservoir and said second portion includes a compartment for containing said drug reservoir with the compartments separated by said barrier means so that said active compound is otherwise isolated from the electrode reservoir and the device may be activated by removing said barrier means to bring the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

7. A user activated iontophoretic device for use in delivering at least one medication through an applied area of a patient, such as the skin, mucus membrane and the like, comprising:

a first portion and a second portion, said first portion including an electrode assembly and a electrode reservoir and said second portion including a drug reservoir;

said electrode assembly including electrode means for driving a medication into the patient to be absorbed by the body of the patient;

said drug reservoir containing an active compound to be delivered to the applied area of the patient, said active compound is initially in a dry form;

barrier means for sealingly maintaining said first portion and said second portion separate from one another, with the electrode assembly maintained in electrically communicating relation with the electrode reservoir, and with the active compound contained by the drug reservoir separated from the electrode reservoir with the barrier means sealing said electrode reservoir in said first portion and sealing said drug reservoir contained in said second portion prior to activation so that upon removal of said barrier means, the electrode reservoir and the drug reservoir are brought into fluid conducting contact with one another so that said drug is dissolved in an aqueous solution contained in said electrode reservoir.

8. A user activated iontophoretic device for use in delivering at least one medication through an applied area of a patient, such as the skin, mucus membrane and the like, comprising:

a first portion and a second portion, said first portion including an electrode assembly and a electrode reservoir and said second portion including a drug reservoir;

said electrode assembly including electrode means for driving a medication into the patient to be absorbed by the body of the patient;

said drug reservoir containing an active compound to be delivered to the applied area of the patient, with the active compound being in a dry form and homogeneously distributed in a carrier material so that the active compound may be kept in a dry form;

barrier means for sealingly maintaining said first portion and said second portion separate from one another, with the electrode assembly maintained in electrically communicating relation with the electrode reservoir, and with the active compound contained by the drug reservoir separated from the electrode reservoir with the barrier means maintaining an aqueous solution in the electrode reservoir intact during storage prior to activation so that upon removal of said barrier means, the electrode reservoir and the drug reservoir are brought into fluid conducting contact with one another so that said drug is dissolved in said aqueous solution contained in said electrode reservoir.

9. A user activated iontophoretic device as defined in claim 8, wherein said barrier means includes an upper release member and a lower release member so that manipulation of said barrier means brings the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

10. A user activated iontophoretic device as defined in claim 9, wherein said upper release member and said lower release member are interconnected by a pull tab member extending from the first portion and the second portion so that upon pulling the tab member to remove the barrier from therebetween, the electrode reservoir and the drug reservoir are brought into contact with one another.

11. A user activated iontophoretic device as defined in claim 8, wherein said first portion includes a compartment for at least containing the electrode reservoir and said second portion includes a compartment for containing said drug reservoir with the compartments separated by said barrier means so that said active compound is otherwise isolated from the electrode reservoir and the device may be activated by removing said barrier means to bring the electrode reservoir and the drug reservoir into electrical conducting contact with one another.

12. A user activated iontophoretic device as defined in claim 8, wherein the electrode reservoir includes an electrolyte in the form of an electrically conductive gel.

13. A user activated iontophoretic device as defined in claim 8, wherein the active compound is selected from the group consisting of cell adhesion molecules, GPIIb/IIIa receptor antagonists for the treatment of various thromboembolic disorders.

14. A method of iontophoretically delivering at least one medication through an applied area of a patient such as the skin, mucus membrane or the like, comprising the steps of:

exposing a first portion of a device including an electrode reservoir by manipulating a first release member;

exposing a second portion of the device including a drug reservoir containing an active compound to be delivered to the patient by manipulating a second release member;

bringing the electrode reservoir of the first portion of the device into fluid conducting contact with the drug reservoir of the second portion of the device to hydrate said drug reservoir and to form a combined reservoir, with the combined reservoir of the device to be applied to an area of the patient to be treated; and

causing current to flow through the device into the applied area to drive the medication into the body of the patient.

15. A method of iontophoretically delivering at least one medication as defined in claim 14, wherein the step of bringing the two portions into contact with one another includes pulling a tab member to simultaneously remove the upper and lower release members from the device separating the first portion from the second portion to bring the electrode reservoir and the drug reservoir into contact with one another.

16. A method of iontophoretically delivering at least one medication as defined in claim 14, further comprising the step of removing a patch from said first portion for application to the skin of the patient.

17. A method of iontophoretically delivering at least one medication as defined in claim 14, wherein said step of bringing said electrode reservoir and said drug reservoir into contact with one another includes dissolving the drug contained in said drug reservoir into said electrode reservoir.

18. A method of iontophoretically delivering at least one medication as defined in claim 14, further comprising the step of removing a patch and a controller from said first portion for application to the skin of the patient.