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Last Updated: March 29, 2024

Details for Patent: 9,339,552


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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)
Filing Date:Oct 26, 2015
Application Number:14/922,903
Claims:1. A topical formulation consisting of: diclofenac sodium present at 2% w/w; DMSO present at 40 to 50% w/w; hydroxypropyl cellulose; 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 DMSO is 45.5% w/w.

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

4. The topical formulation of claim 2, wherein the concentration of the propylene glycol is 11% w/w.

5. The topical formulation of claim 2, wherein the concentration of the propylene glycol is 12% w/w.

6. The topical formulation of claim 1 wherein the concentration of the hydroxypropyl cellulose is 2.5% w/w.

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

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

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

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

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

12. The method of claim 11, wherein the formulation is topically administered to the knee 2 times per day.

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

14. The method of claim 13, wherein the formulation is topically administered to the knee 2 times per day.

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