Methods of treatment utilizing topical emulsion-gel composition comprising diclofenac sodium
AssigneeNovartis Consumer Health S.A.
InventorMichel Steiger
Life of this patent
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Abstract
The invention relates to methods for treating burns or inflammation utilizing beneficial pharmaceutical compositions comprising diclofenac sodium salt in unusually low amounts. The compositions represent opaque emulsion-gels, in which diclofenac is kept fully dissolved.
Claims20
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 C2-C4-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.
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 C2-C4-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.
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 C2-C4-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 C12-C18 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.
Dependencies are inferred from the claim text.