Claims for Patent: 10,478,502

Summary for Patent: 10,478,502

Title:	Pharmaceutical formulations containing corticosteroids for topical administration
Abstract:	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.
Inventor(s):	Arturo Angel, Gordon Dow
Assignee:	Bausch Health Ireland Ltd
Application Number:	US15/615,752
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,478,502
Patent Claims:	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.