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Claims for Patent: 9,220,784

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Claims for Patent: 9,220,784

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:14/705,649
Patent Claims: 1. A method for treating pain associated with joint diseases characterized by joint pain, degeneration of articular cartilage, impaired movement, and/or stiffness, said method comprising: administering a formulation, the formulation comprising: diclofenac sodium present at 2% w/w; DMSO present at 25% to 60% w/w; and a viscosity of 500-5000 centipoise, wherein the administration of the formulation is twice daily, to thereby effectively treat pain.

2. The method of claim 1, wherein the formulation consists essentially of: 30-60% w/w of DMSO; 1-15% w/w of propylene glycol; 1-30% w/w of ethanol; optionally glycerine; water; and at least one thickening agent selected from the group consisting of a cellulose polymer, a carbomer polymer, a carbomer derivative, a cellulose derivative, and mixtures thereof.

3. The method of claim 2, wherein the concentration of DMSO is about 40% to about 50% w/w.

4. The method of claim 3, wherein the concentration of DMSO is a member selected from the group consisting of 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49% and 50% w/w, and all fractions in between.

5. The method of claim 2, wherein the concentration of ethanol is present at 23-29% w/w.

6. The method of claim 2, wherein the at least one thickening agent is selected from the group consisting of a carbomer polymer, a carbomer derivative and mixtures thereof.

7. The method of claim 6, wherein the at least one thickening agent is selected from the group consisting of carbopol 971, carbopol 981, carbopol 941, carbopol 1342 and ultrez 10.

8. The method of claim 7, wherein glycerine is present.

9. The method of claim 2, wherein the at least one thickening agent is selected from the group consisting of a cellulose polymer, a cellulose derivative, and mixtures thereof.

10. The method of claim 9, wherein the at least one thickening agent is hydroxypropyl cellulose.

11. The method of claim 10, wherein the formulation consists essentially of: 2% w/w diclofenac sodium; 40-50% w/w of DMSO; 23-29% w/w of ethanol; hydroxypropyl cellulose; water; and 10-12% w/w of propylene glycol.

12. The method of claim 11, wherein the concentration of DMSO is a member selected from the group consisting of 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49% and 50% w/w, and all fractions in between.

13. The method of claim 1, wherein the formulation has improved absorption on a per dose basis compared to a comparative liquid composition.

14. The method of claim 1, wherein the pain is due to osteoarthritis.
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