Methods of treatment utilizing topical emulsion-gel composition comprising diclofenac sodium

1. A method for treating burns comprising topically administering to the affected area a low-dose diclofenac composition in the form of a pharmaceutically acceptable opaque emulsion-gel which comprises:

(a) 0.1-0.4% (w/w) of diclofenac sodium salt,

(b) at least 50% (w/w) of water,

(c) 0-30% (w/w) of at least one C 2 -C 4 -alkanol,

(d) 3-20% (w/w) of a glycol solvent selected from the group consisting of propylene glycol and polyethylene glycol (200-20000),

(e) 0.2-3% (w/w) of at least one gelling agent selected from the group consisting of carbomers,

(f) 2-8% (w/w) of at least one lipid forming the oily phase of the emulsion-gel,

(g) 1-5% (w/w) of at least one non-ionic surfactant, and

(h) a basic agent selected from the group consisting of ammonia, sodium hydroxide and potassium hydroxide to adjust the pH of the total composition to 6.5-8;

wherein the composition is devoid of an antifungal drug, and is free of antioxidants and chelating agents.

2. A method for treating inflammation comprising topically administering to the affected area a low-dose diclofenac composition in the form of a pharmaceutically acceptable opaque emulsion-gel which comprises:

(a) 0.1-0.4% (w/w) of diclofenac sodium salt,

(b) at least 50% (w/w) of water,

(c) 0-30% (w/w) of at least one C 2 -C 4 -alkanol,

(d) 3-20% (w/w) of a glycol solvent selected from the group consisting of propylene glycol and polyethylene glycol (200-20000),

(e) 0.2-3% (w/w) of at least one gelling agent selected from the group consisting of carbomers,

(f) 2-8% (w/w) of at least one lipid forming the oily phase of the emulsion-gel,

(g) 1-5% (w/w) of at least one non-ionic surfactant, and

(h) a basic agent selected from the group consisting of ammonia, sodium hydroxide and potassium hydroxide to adjust the pH of the total composition to 6.5-8;

wherein the composition is devoid of an antifungal drug, and is free of antioxidants and chelating agents.

3. A method according to claim 1 wherein (a) of said composition is 0.1% (w/w) of diclofenac sodium salt.

4. A method according to claim 2 wherein (a) of said composition is 0.1% (w/w) of diclofenac sodium salt.

5. A method according to claim 3 wherein said composition comprises:

(b) 60-92% of water,

(c) 0-25% of ethanol, isopropanol, or mixtures thereof,

(d) 3-20% of propylene glycol,

(e) 0.3-2% of at least one gelling agent selected from the group consisting of carbomers,

(f) 3-7% of at least one lipid forming the fatty phase of the emulsion-gel selected from mixtures of paraffin and C 6 -C 12 -alkanoic acid C 12 -C 18 -alkyl esters, and isopropyl myristate and C 6 -C 12 -alkanoic acid C 12 -C 18 -alkyl esters,

(g) 1-3% of at least one non-ionic surfactant, and

(h) ammonia to adjust the pH of the total composition to 6.5-8.

6. A method according to claim 3 wherein (c) of said composition is present in an amount of from 5 to 25%, and (d) is present in an amount of from 3 to 7%.

7. A method according to claim 4 wherein (c) of the composition is present in an amount of from 0 to 4%, and (d) is present in an amount of from 3 to 7%.

8. A method according to claim 3 wherein said composition comprises:

(b) at least 50% (w/w) of water,

(c) 0-30% (w/w) of ethanol, isopropanol, or mixtures thereof,

(d) 3-20% (w/w) of propylene glycol,

(e) 0.2-3% (w/w) of at least one gelling agent selected from the group consisting of carbomers

(f) 2-8% (w/w) of a mixture of liquid paraffin or isopropyl myristate with coco-caprylatelcaprate,

(g) 1-5% (w/w) of at least one non-ionic surfactant which is a polyoxyethylene (10-30) fatty alcohol ether, and

(h) a basic agent selected from the group consisting of ammonia, sodium hydroxide and potassium hydroxide to adjust the pH of the total composition to 6.5-8.

9. A method according to claim 3 wherein said composition is free of added organic amines.

10. A method for treating burns or inflammation comprising topically administering to the affected area a low-dose diclofenac composition in the form of a pharmaceutically acceptable opaque emulsion-gel which comprises:

(a) 0.1-0.4% (w/w) of diclofenac sodium salt,

(b) at least 50% (w/w) of water,

(c) 0-30% (w/w) of at least one C 2 -C 4 -alkanol,

(d) 3-20% (w/w) of a glycol solvent selected from the group consisting of propylene glycol and polyethylene glycol (200-20000),

(e) 0.2-3% (w/w) of at least one gelling agent selected from the group consisting of carbomers,

(f) 2-8% (w/w) of at least one lipid forming the oily phase of the emulsion-gel comprising a mixture of liquid paraffin and caprylic/capric esters with C 12 -C 18 saturated fatty alcohols,

(g) 1-5% (w/w) of at least one non-ionic surfactant selected from polyoxyethylene (10-30) fatty alcohol ethers, and

(h) a basic agent selected from the group consisting of ammonia, sodium hydroxide and potassium hydroxide to adjust the pH of the total composition to 6.5-8;

wherein the composition is devoid of an antifungal drug, and is free of antioxidants and chelating agents.

11. A method for treating burns or inflammation according to claim 10 wherein the emulsion-gel comprises:

(a) 0.1-0.4% (w/w) of diclofenac sodium salt,

(b) at least 50% (w/w) of water,

(c) 0-30% (w/w) of isopropanol,

(d) 3-20% (w/w) of propylene glycol,

(e) 0.2-3% (w/w) of gelling agent selected from carbomers,

(f) 2-8% (w/w) of a mixture of liquid paraffin and coco-caprylate/caprate,

(g) 1-5% (w/w) of polyoxyethylene-20-cetostearyl ether, and

(h) a basic agent selected from the group consisting of ammonia, sodium hydroxide and potassium hydroxide to adjust the pH of the total composition to 6.5-8.

12. A method according to claim 10 wherein the formulation comprises component (a), diclofenac sodium salt, in an amount of 0.1%.

13. A method according to claim 12 wherein the diclofenac sodium is 100% stable following 9 months' storage under conditions of temperature (° C.) and relative humidity (r.h.) of 25° C./60% r.h. or 30° C./60% t.h.

14. A method according to claim 11 wherein the formulation comprises component (a), diclofenac sodium salt, in an amount of 0.1%.

15. A method according to claim 14 wherein the diclofenac sodium is 100% stable following 9 months' storage under conditions of temperature (° C.) and relative humidity (r.h.) of 25° C./60% r.h. or 30° C./60% t.h.

16. A method according to claim 3 wherein the diclofenac sodium is 100% stable following 9 months' storage under conditions of temperature (° C.) and relative humidity (r.h.) of 25° C./60% r.h. or 30° C./60% t.h.

17. A method for treating burns according to claim 10 .

18. A method for treating burns according to claim 11 .

19. A method for treating inflammation according to claim 10 .

20. A method for treating inflammation according to claim 11 .