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 topical formulation consisting of:
diclofenac sodium present at 2% w/w;
DMSO present at 40 to 50% w/w;
hydroxypropyl cellulose;
ethanol present at 23% to 29% w/w;
propylene glycol present at 10% to 12% w/w; and
water to make 100% w/w,
wherein the topical formulation has a viscosity of 500 to 5000 centipoise, and
wherein the formulation has a pH of 4 to 10.
2. The topical formulation of claim 1 , wherein the concentration of DMSO is 45.5% w/w.
3. The topical formulation of claim 1 , wherein the concentration of the propylene glycol is 10% w/w.
4. The topical formulation of claim 2 , wherein the concentration of the propylene glycol is 11% w/w.
5. The topical formulation of claim 2 , wherein the concentration of the propylene glycol is 12% w/w.
6. The topical formulation of claim 1 wherein the concentration of the hydroxypropyl cellulose is 2.5% w/w.
7. The topical formulation of claim 1 , wherein the viscosity is at least 1000 cp.
8. The topical formulation of claim 2 , wherein the viscosity is at least 1000 cp.
9. The topical formulation of claim 1 , wherein the formulation degrades at less than 1% over 6 months.
10. The topical formulation of claim 2 , wherein the formulation degrades at less than 1% over 6 months.
11. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof comprising administering to the knee a topical formulation of claim 1 .
12. The method of claim 11 , wherein the formulation is topically administered to the knee 2 times per day.
13. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof comprising administering to the knee a topical formulation of claim 2 .
14. The method of claim 13 , wherein the formulation is topically administered to the knee 2 times per day.