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Claims for Patent: 9,272,137

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Claims for Patent: 9,272,137

Title:Transdermal methods and systems for the delivery of anti-migraine compounds
Abstract: Iontophoretic patches for the delivery of anti-migraine compounds and methods of using the patches are described.
Inventor(s): Anderson; Carter R. (Inver Grove Heights, MN), Morris; Russell L. (Lindstrom, MN), Sebree; Terri B. (Gladwyne, PA)
Assignee: Teva Pharmaceuticals International GmbH (Rapperswil-Jona, CH)
Application Number:13/105,562
Patent Claims: 1. An integrated iontophoretic transdermal patch for the delivery of a triptan compound or a salt thereof to a human subject, the patch comprising: the triptan compound or the salt thereof disposed in a drug reservoir; a return reservoir; and an electronic circuit in electrical connection with the reservoirs, the electronic circuit comprising: a voltage source; an active electrode; a return electrode; and a transistor, wherein the electronic circuit is pre-configured to provide a two-stage delivery sequence including: a first bolus stage delivery in which an average current density on the skin of the subject through the drug reservoir and an average current density on the skin of the subject through the return reservoir are each between about 0.05 and about 0.20 mA/cm.sup.2 during at least 30% of the delivery time of the first bolus stage delivery and during which the current through the skin of the subject and the drug reservoir is sufficient to achieve a therapeutically effective dosage level of at least 10 ng/mL of the triptan compound or the salt thereof in the plasma of the human subject in less than one hour; and a second maintenance stage delivery in which an average current density on the skin of the subject through the drug reservoir and an average current density on the skin of the subject through the return reservoir are each between about 0.01 and about 0.2 mA/cm.sup.2 during at least 30% of the delivery time of said second maintenance stage delivery and are each lower than both the average current density on the skin of the subject through the drug reservoir and the average current density on the skin of the subject through the return reservoir during the first bolus stage delivery.

2. The patch of claim 1, wherein the active electrode comprises zinc or zinc coating.

3. The patch of claim 1, wherein the triptan compound or the salt thereof is formulated in a flowable hydrogel.

4. The patch of claim 1, wherein the electronic circuit further comprises a pair of control transistors in electrical connection with two or more resistors.

5. The patch of claim 1, wherein the voltage source is a galvanic power battery source.

6. The patch of claim 1, wherein the voltage source is a lithium battery.

7. The patch of claim 1, wherein the triptan compound or the salt thereof is selected from sumatriptan, naratriptan and salts thereof.

8. The patch of claim 1, wherein the triptan compound or the salt thereof is sumatriptan or a salt thereof.

9. The patch of claim 1, wherein the triptan compound or the salt thereof is sumatriptan succinate.

10. The patch of claim 1, wherein the triptan compound or the salt thereof is separated from the electronic circuit prior to patch activation.

11. The patch of claim 1, wherein the electronic circuit is operative to maintain a steady state concentration of the triptan compound in the subject's plasma for at least one hour.

12. The patch of claim 11, wherein the steady state concentration is a plasma concentration of about 10 ng/mL or greater.

13. The patch of claim 11, wherein the electronic circuit is operative to maintain the steady state concentration of the triptan compound for at least four hours.

14. The patch of claim 1, wherein said patch has a shelf life of at least 6 months.

15. The patch of claim 1, wherein said patch weighs less than about 0.1 lb.
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