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Claims for Patent: 8,366,600

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Claims for Patent: 8,366,600

Title:Polyamine enhanced formulations for triptan compound iontophoresis
Abstract: A patch and compositions for iontophoresis of triptan compounds are described.
Inventor(s): Sebree; Terri B. (Gladwyne, PA), Horstmann; Michael (Neuwied, DE), Sameti; Mohammad (Bonn, DE)
Assignee: NuPathe Inc. (Conshohocken, PA)
Application Number:12/214,555
Patent Claims: 1. A method of treating a subject in need thereof, comprising: administering an effective amount of a triptan compound to a subject using an iontophoretic transdermal patch, wherein the patch comprises an anode reservoir and a cathode reservoir, wherein the anode reservoir comprises a polyamine hydrogel formed from a polyamine salt of a polyacrylate copolymer and an organic acid, and a gel forming amount of water; wherein the organic acid is a fatty acid, or a dicarboxylic acid, or a combination of both; wherein the polyamine hydrogel further comprises: about 3% to about 20% of a triptan compound in intimate mixture with the hydrogel; and optionally one or more additives, wherein the effective amount of the triptan compound is delivered to the subject within about one hour at an initial current between about 4 mA and about 5 mA without causing significant erythema.

2. The method of claim 1, wherein said effective amount is effective to treat a triptan compound responsive state.

3. The method of claim 2, wherein said triptan compound responsive state is a migraine.

4. The method of claim 1, wherein the hydrogel comprises at least about 80% water and about 3.0% to about 5.0% triptan compound.

5. The method of claim 1, wherein the hydrogel comprises between about 3% and about 10% polyamine salt.

6. The method of claim 1, wherein the hydrogel comprises between about 10% and about 18% polya mine salt.

7. The method of claim 1, wherein the polyamine salt is a salt of a methacrylate copolymer.

8. The method of claim 1, wherein the methacrylate co-polymer is an alkylated methacrylate copolymer.

9. The method of claim 1, wherein the hydrogel comprises about 0.01% to about 1.0% antimicrobial agent.

10. The method of claim 1, wherein the organic acid comprises lauric acid, which is present in an amount between about 0.5% and about 7.0% .

11. The method of claim 1, wherein the organic acid comprises adipic acid, which is present in an amount between about 0.1% and about 2.0%.

12. The method of claim 1, wherein the triptan compound is almotriptan, frovatriptan, eletriptan, zolmitriptan, rizatriptan, sumatriptan, naratriptan, or a pharmaceutically acceptable salt thereof.

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

14. The method of claim 1, wherein the triptan compound is sumatriptan succinate or sumatriptan hydrochloride.

15. The method of claim 1, wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin pH.

16. The method of claim 1, wherein the patch is capable of administering an effective amount of the triptan compound without substantially affecting skin temperature.

17. The method of claim 1, wherein the hydrogel has a pH of about 3 to about 8.

18. The method of claim 17, wherein the hydrogel has a pH of about 5.5 to about 7.

19. The method of claim 18, wherein the hydrogel has a pH of about 6.

20. The method of claim 1, wherein the anode reservoir further comprises a solubility enhancer, a permeation enhancer, an antimicrobial agent or any combination thereof.

21. The method of claim 1, wherein the patch comprises a battery which operates throughout use of the patch.

22. The method of claim 1, wherein the patch delivers a desired concentration of the triptan compound in less than one hour.

23. The method of claim 1, wherein the anode reservoir consists essentially of a polyamine hydrogel formed from: a polyamine salt of a polyacrylate copolymer and adipic acid, and a gel forming amount of water; wherein the polyamine hydrogel further comprises: between about 3% and about 10% of a triptan compound in intimate mixture with the hydrogel, and between about 0.05% and about 0.75% methyl para-hydroxy benzoate.

24. The method of claim 1, wherein the organic acid is a fatty acid, a dicarboxylic acid or a mixture thereof.

25. A method of treating a subject in need thereof, comprising administering an effective amount of sumatriptan or a salt thereof to a subject using an iontophoretic transdermal patch, wherein the patch comprises an anode reservoir and a cathode reservoir, wherein said anode reservoir comprises a polyamine hydrogel formed from: an alkylated methacrylate copolymer, at least about 80% water, between about 1.0% and about 5.0% lauric acid, and between about 0.05% and about 0.75% adipic acid; and wherein the polyamine hydrogel further comprises: between about 3% and about 10% sumatriptan or salt thereof in intimate mixture with the hydrogel, and between about 0.02% and about 0.5% methyl para-hydroxy benzoate; and wherein the effective amount of the triptan compound is delivered to the subject within about one hour at an initial current between about 4 mA and about 5 mA without causing significant erythema.

26. The method of claim 25, wherein sumatriptan or a salt thereof is sumatriptan succinate.

27. A method of treating a subject in need thereof, comprising administering an effective amount of sumatriptan succinate to a subject using an iontophoretic transdermal patch, wherein said patch comprises an anode reservoir and a cathode reservoir, wherein said anode reservoir comprises a polyamine hydrogel formed from: approximately 84% to about 88% water; approximately 4.0% to about 7.0% alkylated methacrylate co-polymer; approximately 1.0% to about 5.0% lauric acid; and approximately 0.05% to about 0.75% adipic acid; wherein the polyamine hydrogel further comprises: approximately 3.0% to about 5.0% sumatriptan succinate in intimate mixture with the hydrogel, and approximately 0.05% to about 0.75% methyl para-hydroxy benzoate; and wherein the effective amount of the triptan compound is delivered to the subject within about one hour at an initial current between about 4 mA and about 5 mA without causing significant erythema.
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