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Claims for Patent: 9,101,591

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Claims for Patent: 9,101,591

Title:Diclofenac topical formulation
Abstract: The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.
Inventor(s): Kisak; Ed (San Diego, CA), Singh; Jagat (Toronto, CA)
Assignee: HZNP LIMITED (Pembroke, BM)
Application Number:14/596,919
Patent Claims: 1. A topical formulation comprising: diclofenac sodium present at 2% w/w; dimethyl sulfoxide present at 40% to 50% w/w; ethanol present at 23% to 29% w/w; propylene glycol present at 10% to 12% w/w; and water to make 100% w/w, wherein the topical formulation has a viscosity of 500 to 5000 centipoise, and wherein the formulation has a pH of 4 to 10.

2. The topical formulation of claim 1, wherein the concentration of the dimethyl sulfoxide is 45.5% w/w.

3. The topical formulation of claim 1, wherein the topical formulation comprises at least one thickening agent.

4. The topical formulation of claim 1, wherein the concentration of the propylene glycol is 10% w/w.

5. The topical formulation of claim 3, wherein the concentration of the dimethyl sulfoxide is 45.5% w/w.

6. The topical formulation of claim 2, wherein propylene glycol is present in an amount of 11% w/w.

7. The topical formulation of claim 2, wherein propylene glycol is present in an amount of 12% w/w.

8. The topical formulation of claim 1, wherein the viscosity is at least 1000 cp.

9. The topical formulation of claim 2, wherein the viscosity is at least 1000 cp.

10. The topical formulation of claim 1, wherein the formulation degrades at less than 1% over 6 months.

11. The topical formulation of claim 2, wherein the formulation degrades at less than 1% over 6 months.

12. A topical formulation consisting essentially of: 2% w/w diclofenac sodium, 45.5% w/w DMSO, 23-29% w/w ethanol, 10-12% w/w propylene glycol, at least one thickening agent, and water, wherein the topical formulation a viscosity of 500-5000 cp.

13. The topical formulation of claim 12, wherein the at least one thickening agent comprises hydroxypropyl cellulose.

14. The topical formulation of claim 13, wherein the hydroxypropyl cellulose is present in an amount of 2.5% w/w.

15. The topical formulation of claim 12, wherein the pH is 4 to 10.

16. The topical formulation of claim 12, wherein propylene glycol is present in an amount of 10% w/w.

17. The topical formulation of claim 12, wherein propylene glycol is present in an amount of 11% w/w.

18. The topical formulation of claim 12, wherein propylene glycol is present in an amount of 12% w/w.

19. The topical formulation of claim 12, wherein the formulation degrades at less than 1% over 6 months.

20. A method for treating the pain of osteoarthritis of the knee in a patient in need thereof comprising topically administering to the knee of the patient a formulation of claim 1.

21. The method of claim 20, wherein the formulation is topically administered to the knee 2 times per day.

22. A method for treating the pain of osteoarthritis of the knee in a patient in need thereof comprising topically administering to the knee of the patient a formulation of claim 2.

23. The method of claim 22, wherein the formulation is topically administered to the knee 2 times per day.

24. A method for treating the pain of osteoarthritis of the knee in a patient in need thereof comprising topically administering to the knee of the patient a formulation of claim 12.

25. The method of claim 24, wherein the formulation is topically administered to the knee 2 times per day.
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