Claims for Patent: 11,839,656

Summary for Patent: 11,839,656

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:	US17/993,806
Patent Claims:	1. A method of treating a dermatological or mucosal disorder or condition, the method comprising topically administering a pharmaceutical composition comprising a corticosteroid to the affected area of skin of an individual having the dermatological or mucosal disorder or condition, wherein the pharmaceutical composition comprises: a corticosteroid, wherein the corticosteroid is halobetasol propionate, and wherein the concentration of the corticosteroid is from about 0.01% to about 0.03%; a liquid oil component, wherein the liquid oil component comprises one or more materials that are practically insoluble or insoluble in water and which are liquid at room temperature of 22° C.; and an aqueous component; wherein the pharmaceutical composition is formulated as a lotion; wherein the pharmaceutical composition provides delivery of the corticosteroid preferentially into the skin; and wherein the method comprises administering the pharmaceutical composition for a period of treatment longer than two weeks. 2. The method of claim 1, wherein the concentration of the halobetasol propionate is about 0.01%. 3. The method of claim 1, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic ester, or a combination thereof. 4. The method of claim 3, wherein the liquid oil component comprises a dicarboxylic acid ester. 5. The method of claim 3, wherein the liquid oil component comprises a monocarboxylic acid ester. 6. The method of claim 3, wherein the liquid oil component further comprises mineral oil or light mineral oil. 7. The method of claim 1, wherein the concentration of the liquid oil component is sufficient to dissolve the corticosteroid in the composition at a temperature of 22° C.±2° C. 8. The method of claim 1, wherein the concentration of the liquid oil component is between 1.0 and 1.5 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C. 9. The method of claim 1, wherein the concentration of the liquid oil component is between 1.5 and 3 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C. 10. The method of claim 1, wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, and/or thickening agents. 11. The method of claim 10, wherein the composition further comprises an emulsifying agent. 12. The method of claim 11, wherein the emulsifying agent is sorbitan monooleate. 13. The method of claim 1, wherein the composition further comprises a pH adjusting agent. 14. The method of claim 1, wherein the composition maintains a VCA score similar to the VCA score obtained by Ultravate® (a topical formulation containing 0.05% halobetasol propionate). 15. The method of claim 1, wherein the method provides an equivalent or better efficacy in treating a dermatological disorder compared to that provided by Ultravate® (a topical formulation containing 0.05% halobetasol propionate). 16. The method of claim 15, wherein the dermatological disorder is psoriasis. 17. The method of claim 1, wherein the method provides reduced local or systemic side effects when treating a dermatological disorder compared to Ultravate® (a topical formulation containing 0.05% halobetasol propionate). 18. The method of claim 17, wherein the dermatological disorder is psoriasis. 19. The method of claim 1, wherein the dermatological or mucosal disorder or condition is psoriasis, atopic dermatitis, contact dermatitis, hand dermatitis, eczema, or poison ivy dermatitis. 20. The method of claim 19, wherein the dermatological or mucosal disorder or condition is psoriasis. 21. A method of treating psoriasis, the method comprising topically administering a pharmaceutical composition comprising a corticosteroid to the affected area of skin of an individual having psoriasis, wherein the pharmaceutical composition comprises: a corticosteroid, wherein the corticosteroid is halobetasol propionate, wherein the concentration of the corticosteroid is about 0.01%; a liquid oil component, wherein the liquid oil component comprises a dicarboxylic acid, a moncarboxylic acid, or a combination thereof, and wherein the concentration of the liquid oil component is sufficient to dissolve the corticosteroid in the composition at a temperature of 22° C.±2° C.; and an aqueous component; wherein the pharmaceutical composition is formulated as a lotion; wherein the pharmaceutical composition provides delivery of the corticosteroid preferentially into the skin; and wherein the method comprises administering the pharmaceutical composition for a period of treatment longer than two weeks.