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Generated: July 26, 2017

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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: Nuvo Research Inc. (Mississauga, Ontario, CA)
Application Number:14/025,781
Patent Claims: 1. A method for treating pain, said method comprising: administering a formulation, the formulation comprising: diclofenac sodium present at 1-5% 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 comprises: (i) 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 5.0% w/w and all fractions in between, of diclofenac sodium; (ii) 30-60% w/w of DMSO; (iii) 1-15% w/w of propylene glycol; (iv) 1-30% w/w of ethanol; (v) optionally glycerine; (vi) water; (vii) 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 1, wherein the concentration of diclofenac sodium is a member selected from the group consisting of 1%, 1.5% and 2% w/w, and all fractions in between.

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

5. The method of claim 4, 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.

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

7. 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.

8. The method of claim 7, 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.

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

10. 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.

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

12. The method of claim 11, wherein the formulation comprises: (i) 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 or 5.0% w/w, and all fractions in between, of diclofenac sodium; (ii) 40-50% w/w of DMSO; (iii) 23-29% w/w of ethanol; and (iv) 10-12% w/w of propylene glycol.

13. The method of claim 12, wherein the concentration of diclofenac sodium is a member selected from the group consisting of 1.5% and 2% w/w, and all fractions in between.

14. The method of claim 12, 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.

15. The method of claim 12, wherein the concentration of ethanol is present at 26.5% w/w.

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

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