Pharmaceutical formulations containing corticosteroids for topical administration
View Patent ↗Pharmaceutical compositions for topical application to skin are provided. In some embodiments, the pharmaceutical compositions comprise a corticosteroid and further comprise a liquid oil component comprising one or more dicarboxylic acid esters and/or monocarboxylic acid esters.
1. A pharmaceutical composition for topical application to the skin of an individual comprising:
a liquid oil component comprising diethyl sebacate and a corticosteroid selected from the group consisting of halobetasol propionate, clobetasol propionate, betamethasone dipropionate, diflorasone diacetate, and fluocinonide at a concentration less than 0.05%; and
an aqueous component comprising water;
wherein the composition is free of white petrolatum.
2. The pharmaceutical composition of claim 1 , wherein the liquid oil component further comprises mineral oil or light mineral oil.
3. The pharmaceutical composition of claim 1 , wherein the corticosteroid is halobetasol propionate and the concentration of the halobetasol propionate is 0.03% (w/w) or less.
4. The pharmaceutical composition of claim 1 , wherein the corticosteroid is halobetasol propionate and the concentration of the halobetasol propionate is 0.01% (w/w) or less.
5. The pharmaceutical composition of claim 1 , wherein the concentration of the liquid oil component is sufficient to dissolve the amount of corticosteroid in the composition at a temperature of 22° C.±2° C.
6. The pharmaceutical composition of claim 5 , wherein the concentration of the liquid oil component is between 1.5 and 3 times that required to completely solubilize the amount of corticosteroid in the composition at a temperature of 22° C.±2° C.
7. The pharmaceutical composition of claim 6 , wherein the concentration of the liquid oil component is between 1.75 and 2.75 times that required to completely solubilize the amount of corticosteroid in the composition at a temperature of 22° C.±2° C.
8. The pharmaceutical composition of claim 1 , wherein the liquid oil component further comprises an emulsifying agent.
9. The pharmaceutical composition of claim 1 , wherein the aqueous component further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, and/or thickening agents.
10. The pharmaceutical composition of claim 1 , further comprising a pH adjusting agent.
11. The pharmaceutical composition of claim 1 , wherein the composition is formulated as an oil-in-water emulsion, a water-in-oil emulsion, an oil-in-water-in-oil emulsion, or a multivesicular emulsion.
12. The pharmaceutical composition of claim 1 , wherein the composition is formulated as a lotion, a gel, a cream, or an ointment.
13. A method of treating a disorder of the skin that is amenable to treatment with a topical corticosteroid, the method comprising applying the pharmaceutical composition of claim 1 to the skin of an individual having the disorder in an amount that is effective in ameliorating the signs or symptoms of the disorder.
14. The method of claim 13 , wherein the disorder is psoriasis, atopic dermatitis, contact dermatitis, hand dermatitis, eczema, or poison ivy dermatitis.
15. The method of claim 13 , wherein the method comprises applying the pharmaceutical composition over a period of treatment of up to two weeks.
16. The method of claim 13 , wherein the method comprises applying the pharmaceutical composition over a period of treatment longer than two weeks.