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 method for treating pain associated with joint diseases characterized by joint pain, degeneration of articular cartilage, impaired movement, and/or stiffness, said method comprising: administering a formulation, the formulation comprising: diclofenac sodium present at 2% 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 consists essentially of:
30-60% w/w of DMSO;
1-15% w/w of propylene glycol;
1-30% w/w of ethanol;
optionally glycerine;
water; and
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 2 , wherein the concentration of DMSO is about 40% to about 50% w/w.
4. The method of claim 3 , 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.
5. The method of claim 2 , wherein the concentration of ethanol is present at 23-29% w/w.
6. 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.
7. The method of claim 6 , 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.
8. The method of claim 7 , wherein glycerine is present.
9. 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.
10. The method of claim 9 , wherein the at least one thickening agent is hydroxypropyl cellulose.
11. The method of claim 10 , wherein the formulation consists essentially of:
2% w/w diclofenac sodium;
40-50% w/w of DMSO;
23-29% w/w of ethanol;
hydroxypropyl cellulose;
water; and
10-12% w/w of propylene glycol.
12. The method of claim 11 , 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.
13. The method of claim 1 , wherein the formulation has improved absorption on a per dose basis compared to a comparative liquid composition.
14. The method of claim 1 , wherein the pain is due to osteoarthritis.