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Claims for Patent: 9,327,114

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Claims for Patent: 9,327,114

Title:User-activated self-contained co-packaged iontophoretic drug delivery system
Abstract: A user-activated self-contained co-packaged iontophoretic drug delivery system and method of use for treatment of a subject are described.
Inventor(s): Sebree; Terri B. (Gladwyne, PA), Stathopulos; Robert P. (Boonton, NJ), Vinatoru; Mihai A. (Graham, NC)
Assignee: Teva Pharmaceuticals International GmbH (Rapperswil-Jona, CH)
Application Number:13/802,156
Patent Claims: 1. A self-contained co-packaged single-use iontophoretic drug delivery system comprising: a first electrode; a second electrode; an integrated power controller in electrical connection with the first and second electrodes; circuitry connecting the first electrode and the second electrode with the integrated power controller; a first conductive reservoir aligned with the first electrode, the first conductive reservoir comprising a first conductive medium and a therapeutic compound; a second conductive reservoir aligned with the second electrode, the second conductive reservoir comprising a second conductive medium; a removable barrier forming a first barrier seal removably disposed between the first electrode and the first conductive reservoir, wherein the first conductive reservoir comprises the first conductive medium and the therapeutic compound while the first barrier seal remains intact, and wherein the first conductive medium and the first electrode are configured to adhere to each other forming electrical contact only after removal of the removable barrier; a second removable barrier forming a second barrier seal removably disposed between the second electrode and the second conductive reservoir, wherein the second conductive medium and the second electrode are configured to adhere to each other forming electrical contact only after removal of the second removable barrier layer; a first transfer ring configured to affix the first conductive medium to the first electrode after removal of the removable barrier and to maintain a position of the first conductive medium relative to the first electrode during use; a second transfer ring configured to affix the second conductive medium to the second electrode after removal of the second removable barrier and to maintain a position of the second conductive medium relative to the second electrode during use; and a removable protective housing which supports the first electrode, the first conductive reservoir, the second electrode, the second conductive reservoir and the power controller, the housing comprising a top housing portion coupled to a bottom housing portion; wherein a portion of the removable barrier extends outside the housing.

2. The iontophoretic drug delivery system of claim 1, wherein the removable barrier is configured to be removed while the first electrode, the second electrode, the power controller, the first conductive reservoir and the second conductive reservoir remain within the housing.

3. The iontophoretic drug delivery system of claim 1, wherein the top housing portion is deformable and configured to cause the first conductive medium to contact the first electrode when force is exerted on the top housing portion, the bottom housing portion or both after the removable barrier is removed.

4. The iontophoretic drug delivery system of claim 1, further comprising at least one battery disposed within the housing for supplying current to the first electrode and the second electrode.

5. The iontophoretic drug delivery system of claim 1, further comprising a support layer for supporting the power controller, the first electrode and the second electrode.

6. The iontophoretic drug delivery system of claim 1, further comprising a receiving layer having a first recess for receiving the first conductive medium and a second recess for receiving the second conductive medium.

7. The iontophoretic drug delivery system of claim 1, wherein the removable barrier has at least one non-stick portion for contacting the first conductive medium.

8. The iontophoretic drug delivery system of claim 1, wherein a portion of the removable barrier extending outside the housing comprises a tab.

9. The iontophoretic drug delivery system of claim 1, wherein the first conductive medium comprises a hydrogel.

10. The iontophoretic drug delivery system of claim 1, wherein the first conductive medium comprises a polyamide.

11. The iontophoretic drug delivery system of claim 1, wherein the therapeutic compound comprises a triptan compound.

12. The iontophoretic drug delivery system of claim 11, wherein triptan compound is sumatriptan.

13. The iontophoretic drug delivery system of claim 1, wherein the bottom housing portion supports the first conductive reservoir and the second conductive reservoir.

14. A method of treating a subject comprising administering to a subject a drug using the iontophoretic drug delivery system of claim 1.

15. A method for treating a triptan responsive state comprising administering to a subject an effective amount of a triptan compound using the iontophoretic drug delivery system of claim 11.

16. A method for treating a triptan responsive state comprising administering to a subject an effective amount of sumatriptan using the iontophoretic drug delivery system of claim 12.

17. A self-contained co-packaged iontophoretic drug delivery system comprising: an electrode region, comprising: a first electrode; and a second electrode; a power controller for controlling current supplied to the first electrode and the second electrode; circuitry connecting the first electrode and the second electrode with the power controller; a therapeutic compound region, comprising: a first conductive medium vertically aligned with the first electrode; a second conductive medium vertically aligned with the second electrode; and a therapeutic compound in solution disposed in the first conductive medium; a protective housing substantially enclosing the electrode region, the power controller region, the circuitry and the therapeutic compound region; a removable barrier layer separating a portion of the electrode region from a portion of the therapeutic compound region, the removable barrier layer having a portion accessible from outside the housing; and wherein the removable barrier layer is configured to be removed while the electrode region, the power controller, the circuitry and the therapeutic compound remain within the housing; and wherein upon removal of the barrier layer, the first conductive medium adheres to the first electrode and makes electrical contact therewith, and the second conductive medium adheres to the second electrode and makes electrical contact therewith; a first transfer ring configured to maintain a position of the first conductive medium relative to the first electrode during use; and a second transfer ring configured to maintain a position of the second conductive medium relative to the second electrode during use.

18. A method of treating a subject comprising administering to a subject a drug using the iontophoretic drug delivery system of claim 17.
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