# US 10,478,502 B2 · Pharmaceutical formulations containing corticosteroids for topical administration > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,478,502 B2 - Document ID: US10478502B2 - Status: Granted - Kind: B2 - Application number: 15/615,752 - Filed: 2017-06-06 - Published: 2017-09-21 - Granted: 2019-11-19 - Earliest claimed: 2010-11-22 - Assignees: Dow Pharmaceutical Sciences, Inc. - Applicants: Dow Pharmaceutical Sciences, Inc. - Inventors: Arturo Angel; Gordon Dow - Web page: https://patentgrep.com/patent/US10478502B2 ## CPC - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone - A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) - A61P 17/00: Drugs for dermatological disorders - A61P 17/06: Antipsoriatics - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The pharmaceutical composition of claim 1, wherein the liquid oil component further comprises mineral oil or light mineral oil. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 5) 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. ### Claim 7 (depends on 6) 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. ### Claim 8 (depends on 1) The pharmaceutical composition of claim 1, wherein the liquid oil component further comprises an emulsifying agent. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 1) The pharmaceutical composition of claim 1, further comprising a pH adjusting agent. ### Claim 11 (depends on 1) 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. ### Claim 12 (depends on 1) The pharmaceutical composition of claim 1, wherein the composition is formulated as a lotion, a gel, a cream, or an ointment. ### Claim 13 (depends on 1) 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. ### Claim 14 (depends on 13) The method of claim 13, wherein the disorder is psoriasis, atopic dermatitis, contact dermatitis, hand dermatitis, eczema, or poison ivy dermatitis. ### Claim 15 (depends on 13) The method of claim 13, wherein the method comprises applying the pharmaceutical composition over a period of treatment of up to two weeks. ### Claim 16 (depends on 13) The method of claim 13, wherein the method comprises applying the pharmaceutical composition over a period of treatment longer than two weeks.