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Claims for Patent: 8,597,272

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Claims for Patent: 8,597,272

Title:Pharmacokinetics of iontophoretic sumatriptan administration
Abstract: Improved pharmacokinetic profiles for the iontophoretic delivery of sumatriptan are described.
Inventor(s): Sebree; Terri B. (Gladwyne, PA), Pierce; Mark (Essex, CT), O'Neill; Carol (Phoenixville, PA)
Assignee: Nupathe, Inc. (Malvern, PA)
Application Number:13/407,434
Patent Claims: 1. An iontophoretic patch designed to iontophoretically deliver sumatriptan using a current of about 4 mA for a high current treatment period of about one hour and a current of about 2.0 mA for a subsequent low current treatment period of about three hours.

2. The patch of claim 1, wherein said iontophoretic patch is integrated.

3. The patch of claim 2, wherein said patch employs a current density of at least about 0.10 mA/cm.sup.2 or higher for at least a portion of said high current density treatment period.

4. The patch of claim 3, wherein the current density of said high current density period is between about 0.10 mA/cm.sup.2 and 0.5 mA/cm.sup.2.

5. The patch of claim 3, wherein said patch has an iontophoretically active surface area of about 10 cm.sup.2 or greater.

6. The patch of claim 5, wherein said surface area is about 30 cm.sup.2.

7. The patch of claim 1, wherein the amount of said sumatriptan delivered is about 10 mg.

8. The patch of claim 1, wherein said patch comprises a cathode reservoir and an anode reservoir, and wherein said cathode reservoir comprises 2% hydroxypropyl cellulose and sodium chloride.

9. The patch of claim 8, wherein said cathode reservoir comprises 2% of hydroxypropyl cellulose in an amount of about 3.0 g.

10. The patch of claim 9, wherein said anode reservoir comprises sumatriptan or a pharmaceutically acceptable salt thereof present in a gel solution.

11. The patch of claim 10, wherein said gel solution comprises 4% sumatriptan succinate.

12. The patch of claim 11, wherein said gel solution further comprises 10% polyamine.

13. The patch of claim 1, wherein said delivery of sumatriptan results in an AUC.sub.0-inf within a 95% confidence interval between about 67 and about 158 hr*ng/mL.

14. The patch of claim 13, wherein said delivery of sumatriptan results in an AUC.sub.0-inf within a 95% confidence interval between about 99 and about 128 hr*ng/mL.

15. The patch of claim 1, wherein said delivery of sumatriptan results in an AUC.sub.0-inf between about 67 and about 158 hr*ng/mL.

16. The patch of claim 15, wherein said delivery of sumatriptan results in an AUC.sub.0-inf between about 99 and about 128 hr*ng/mL.

17. The patch of claim 1, wherein said delivery of sumatriptan results in a C.sub.max within a 95% confidence interval of between about 14 and about 38 ng/mL.

18. The patch of claim 17, wherein said delivery of sumatriptan results in a C.sub.max within a 95% confidence interval between about 20 and about 28 ng/mL.

19. The patch of claim 1, wherein said delivery of sumatriptan results in a C.sub.max of about 23-25 ng/mL is achieved and plasma concentrations are sustained for at least three hours.

20. The patch of claim 1, wherein said delivery of sumatriptan results in an AUC.sub.0-inf between about 99 and 128 hr*ng/mL and a C.sub.max between about 20 to about 28 ng/mL.

21. The patch of claim 1, wherein sumatriptan is sumatriptan succinate.
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