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Claims for Patent: 9,066,913

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Claims for Patent: 9,066,913

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:14/497,096
Patent Claims: 1. A topical formulation comprising: diclofenac sodium present at 2% w/w; DMSO present at about 40 to about 50% w/w; ethanol present at 23-29% w/w; propylene glycol present at 10-12% w/w; hydroxypropyl cellulose; and water to make 100% w/w, wherein the formulation has a viscosity of 500-5000 centipoise.

2. The topical formulation of claim 1, wherein the formulation has a pH of 6 to 10.

3. The topical formulation of claim 1, wherein the propylene glycol is present at 11.2% w/w.

4. The topical formulation of claim 1, wherein the topical formulation produces less than 0.1% impurity A after 6 months at 25.degree. C. and 60% humidity.

5. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 1, wherein the administration of the formulation is twice daily.

6. The method of claim 5, wherein 2 mL of said topical formulation is administered to the knee twice daily.

7. The method of claim 5, wherein the amount of diclofenac sodium administered to the knee is 40 mg twice daily.

8. The topical formulation of claim 1, wherein the DMSO is present at 45.5% w/w.

9. The topical formulation of claim 8, wherein the hydroxypropyl cellulose is present at 2.5% w/w.

10. The topical formulation of claim 1, wherein the hydroxypropyl cellulose is present at 2.5% w/w.

11. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 8, wherein the administration of the formulation is twice daily.

12. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 9, wherein the administration of the formulation is twice daily.
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