Claims for Patent: 9,539,335

Summary for Patent: 9,539,335

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:	15/092,139
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,539,335
Patent Claims:	1. A process for making a topical formulation, comprising: adding hydroxypropyl cellulose to a mixture of dimethylsulfoxide, water, diclofenac sodium, propylene glycol, and ethanol, wherein the topical formulation consists of: 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 process of claim 1, further comprising packaging the topical formulation into a dispenser. 3. The process of claim 1, wherein the topical formulation has a pH of 6 to 10. 4. The process of claim 1, wherein the topical formulation has a viscosity of at least 1000 centipoise. 5. The process of claim 1, wherein propylene glycol is present at 11.2% w/w. 6. The process of claim 1, wherein DMSO is present at 45.5% w/w. 7. The process of claim 1, wherein hydroxypropyl cellulose is present at 2.5% w/w. 8. The process of claim 1 wherein the topical formulation consists of: diclofenac sodium present at 2% w/w; DMSO present at 45.5% w/w; ethanol present at 23-29 w/w %; propylene glycol present at 10-12% w/w; hydroxypropyl cellulose present at 2.5%; and water to make 100% w/w; wherein the formulation has a viscosity of 500-5000 centipoise. 9. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee twice daily a topical formulation prepared by the process of claim 1. 10. The method of claim 9, wherein 2 mL of said topical formulation is administered to the knee twice daily. 11. The method of claim 9, wherein the amount of diclofenac sodium administered to the knee is 40 mg twice daily. 12. The method of claim 9, wherein the topical formulation has a pH of 6 to 10. 13. The method of claim 9, wherein the topical formulation has a viscosity of at least 1000 centipoise. 14. The method of claim 9, wherein propylene glycol is present at 11.2% w/w. 15. The method of claim 9, wherein DMSO is present at 45.5% w/w. 16. The method of claim 9, wherein hydroxypropyl cellulose is present at 2.5% w/w. 17. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee twice daily a topical formulation prepared by the process of claim 8. 18. The method of claim 17, wherein 2 mL of said topical formulation is administered to the knee twice daily. 19. The method of claim 17, wherein the amount of diclofenac sodium administered to the knee is 40 mg twice daily.