Diclofenac topical formulation
View Patent ↗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.
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.