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Claims for Patent: 9,370,501

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Claims for Patent: 9,370,501

Title:Treatment of pain with topical diclofenac
Abstract: The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s): Singh; Jagat (Scarborough, CA), Shainhouse; Joseph Zev (North York, CA), Galer; Bradley S. (West Chester, PA), King-Smith; Robert Dominic (San Diego, CA), Grierson; Lisa Marie (Richmond Hill, CA), Burian; Maria (Stolberg, DE), Wilkin; Jonathan (Columbus, OH), Kisak; Edward (San Diego, CA), Newsam; John M. (La Jolla, CA)
Assignee: HZNP Limited (Pembroke, BM)
Application Number:14/804,715
Patent Claims: 1. A method for applying topical agents to a knee of a patient with pain, said method comprising: applying a first medication comprising a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation consists of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; a C.sub.1-C.sub.4 alkanol; a polyhydric alcohol; a thickening agent; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise; waiting for the treated area to dry; and subsequently applying a second prescription medication consisting of a topical medication other than said first medication to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient in which said topical diclofenac preparation is administered twice daily.

2. The method according to claim 1, wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.

3. The method according to claim 1, wherein said step of applying a first medication does not enhance the systemic absorption of the subsequently applied second medication consisting of a topical medication other than said first medication.

4. A method for applying topical agents to a knee of a patient with pain, said method comprising: applying a first medication comprising a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation wherein the topical diclofenac preparation consists of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; a C.sub.1-C.sub.4 alkanol; a polyhydric alcohol; a thickening agent; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise; waiting for the treated area to dry; and subsequently applying a second prescription medication consisting of a topical medication other than said first medication to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient in which said topical diclofenac preparation is administered twice daily; and wherein said step of applying a first medication does not enhance the systemic absorption of the subsequently applied second medication consisting of a topical medication other than said first medication.

5. The method according to claim 4, wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.

6. The method of claim 1, wherein the thickening agent is selected from acrylic polymers, acrylic polymer derivatives, cellulose polymers, cellulose polymer derivatives, polyvinyl alcohol, poloxamers, polysaccharides and mixtures thereof.

7. The method of claim 6, wherein the thickening agent is a cellulose polymer.

8. The method of claim 7, wherein the cellulose polymer is hydroxypropyl cellulose.

9. The method of claim 8, wherein hydroxypropyl cellulose is present at about 0-6% w/w.

10. The method of claim 1, wherein the C.sub.1-C.sub.4 alkanol is selected from methanol, ethanol, propanol, butanol and mixtures thereof.

11. The method of claim 10, wherein the C.sub.1-C.sub.4 alkanol is ethanol.

12. The method of claim 11, wherein ethanol is present at about 1-50% w/w.

13. The method of claim 1, wherein the polyhydric alcohol is a glycol.

14. The method of claim 13, wherein the glycol is selected from ethylene glycol, propylene glycol, butylene glycol, dipropylene glycol, hexanetriol and mixtures thereof.

15. The method of claim 14, wherein the glycol is propylene glycol.

16. The method of claim 15, wherein propylene glycol is present at about 1-15% w/w.

17. The method of claim 4, wherein the thickening agent is selected from acrylic polymers, acrylic polymer derivatives, cellulose polymers, cellulose polymer derivatives, polyvinyl alcohol, poloxamers, polysaccharides and mixtures thereof.

18. The method of claim 17, wherein the thickening agent is a cellulose polymer.

19. The method of claim 18, wherein the cellulose polymer is hydroxypropyl cellulose.

20. The method of claim 19, wherein hydroxypropyl cellulose is present at about 0-6%.

21. The method of claim 4, wherein the C.sub.1-C.sub.4 alkanol is selected from methanol, ethanol, propanol, butanol and mixtures thereof.

22. The method of claim 21, wherein the C.sub.1-C.sub.4 alkanol is ethanol.

23. The method of claim 1, wherein ethanol is present at about 1-50% w/w.

24. The method of claim 4, wherein the polyhydric alcohol is a glycol.

25. The method of claim 24, wherein the glycol is selected from ethylene glycol, propylene glycol, butylene glycol, dipropylene glycol, hexanetriol and mixtures thereof.

26. The method of claim 25, wherein the glycol is propylene glycol.

27. The method of claim 26, wherein propylene glycol is present at about 1-15% w/w.
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