Topical diclofenac sodium compositions
AssigneeNovartis Consumer Health S.A.
InventorsGregory JOHNSON, Eric WOODWARD
Life of this patent
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Abstract
The invention relates to beneficial topical pharmaceutical compositions comprising diclofenac sodium in high amounts, and methods for their use. Said compositions represent emulsion-gels as well as gels with unique properties such as high skin penetration, no irritation, high stability, complete dissolution of the active and effective pain relief. The invention also provides methods for treating pain or inflammation in a mammalian subject in need thereof, including acute and chronic pain or inflammation; and kits therefor.
Claims30
A topical pharmaceutical composition which comprises:
- (a) 1-5% of diclofenac sodium,
- (b) at least about 50% of water,
- (c) from about 5 to about 20% of at least one C2-C4-alkanol,
- (d) from about 5 to about 25% of a glycol solvent selected from the group consisting of propylene glycol and polyethylene glycol (200-20000),
- (e) from about 0.2 to about 5% of at least one gelling agent selected from the group consisting of carbomers, mixtures of carbomers, and mixtures of one or more carbomers with one or more hydroxy- and/or carboxy-substituted celluloses,
- (f) from 0 to about 10% of a liquid lipid forming an oil phase,
- (g) from 0 to about 5% of at least one non-ionic surfactant, and
- (h) a basic agent to adjust the pH of the total composition to 6-9,
- all percentages being by weight (w/w).
A topical pharmaceutical composition which comprises:
- (a) 2% of diclofenac sodium salt,
- (b) at least about 55% of water,
- (c) from about 10 to about 20% of at least one C2-C4-alkanol,
- (d) from about 10 to about 20% of at least one glycol solvent selected from the group consisting of 1,2-propanediol and polyethylene glycol (200-20000),
- (e) from about 0.5 to about 5% of at least one gelling agent selected from the group consisting of carbomers,
- (f) from 0 to about 10% of a lipid forming an oil phase,
- (g) from 0 to about 5% of at least one non-ionic surfactant, and
- (h) a basic agent to adjust the pH of the total composition to 6-9.
A topical pharmaceutical composition, in the form of an emulsion gel, which comprises:
- (a) 2% (w/w) of diclofenac sodium salt,
- (b) at least about 60% of water,
- (c) from about 10 to about 15% of at least one C2-C4-alkanol,
- (d) from about 10 to about 15% of at least one glycol solvent selected from the group consisting of 1,2-propanediol and polyethylene glycol (200-20000),
- (e) from about 0.7 to about 3% of at least one gelling agent selected from the group consisting of carbomers, and
- (f) from about 3 to about 7% of at least one liquid lipid forming the oily phase of the emulsion-gel,
- (g) from about 1 to about 3% of at least one non-ionic surfactant, and
- (h) from about 0.5 to about 3% of a base to adjust the pH of the total composition to 7-9,
A topical pharmaceutical composition, in the form of an emulsion gel, which comprises:
- (a) 2% (w/w) of diclofenac sodium salt,
- (b) at least about 60% of water,
- (c) from about 10 to about 15% of isopropanol,
- (d) from about 10 to about 15% of propylene glycol,
- (e) from about 0.7 to about 3% of carbomer or mixtures thereof,
- (f) from about 3 to about 7% of at least one liquid lipid forming the oily phase of the emulsion-gel selected from mineral oil and cocoyl caprylocaprate, and mixtures thereof,
- (g) from about 1 to about 3% of polyoxyl 20 ceetostearyl ether, and
- (h) a basic agent to adjust the pH of the total composition to 7-9.
28-30. (canceled)
Dependencies are inferred from the claim text.