Claims for Patent: 11,648,256

Summary for Patent: 11,648,256

Title:	Topical compositions and methods for treating psoriasis
Abstract:	Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.
Inventor(s):	Gordon J. Dow, Radhakrishnan Pillai, Varsha D. Bhatt
Assignee:	Bausch Health Ireland Ltd
Application Number:	US17/993,817
Patent Claims:	1. A topical pharmaceutical composition for treating psoriasis, the composition comprising: halobetasol propionate at a concentration of 0.01 percent by weight of the composition; tazarotene at a concentration of 0.045 percent by weight of the composition; 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. 2. The pharmaceutical composition of claim 1, wherein the halobetasol propionate is dissolved in the liquid oil component at room temperature. 3. The pharmaceutical composition of claim 1, wherein the tazarotene is dissolved in the liquid oil component at room temperature. 4. The pharmaceutical composition of claim 1, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic ester, or a combination thereof. 5. The pharmaceutical composition of claim 4, wherein the liquid oil component comprises a dicarboxylic acid ester. 6. The pharmaceutical composition of claim 4, wherein the liquid oil component comprises a monocarboxylic acid ester. 7. The pharmaceutical composition of claim 4, wherein the liquid oil component further comprises mineral oil or light mineral oil. 8. The pharmaceutical composition of claim 7, wherein the liquid oil component further comprises light mineral oil. 9. The pharmaceutical composition of claim 1, wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, and/or thickening agents. 10. The pharmaceutical composition of claim 9, wherein the composition further comprises an emulsifying agent. 11. The pharmaceutical composition of claim 1, wherein the composition further comprises a pH adjusting agent. 12. The pharmaceutical composition of claim 1, wherein the composition is capable of providing a synergistic efficacy when the composition is used to treat psoriasis. 13. The pharmaceutical composition of claim 1, wherein the composition is capable of providing a synergistic reduction is at least one adverse event when the composition is used to treat psoriasis, wherein the adverse event is selected from the group consisting of itching, burning, stinging, and combinations thereof. 14. A pharmaceutical composition for topical application to the skin of an individual, the composition comprising: halobetasol propionate at a concentration of 0.01 percent by weight of the composition; tazarotene at a concentration of 0.045 percent by weight of the composition; a liquid oil component, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof; and an aqueous component; wherein the pharmaceutical composition is formulated as a lotion. 15. The topical pharmaceutical composition of claim 14, wherein the composition further comprises a surfactant, an emulsifying agent, a thickening agent, a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent. 16. A topical pharmaceutical composition for treating psoriasis, the composition comprising: halobetasol propionate at a concentration of 0.01 percent by weight of the composition; tazarotene at a concentration of 0.045 percent by weight of the composition; a liquid oil component, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic acid ester, or a combination thereof, and light mineral oil; and an aqueous component, wherein the aqueous component comprises purified water; a carbomer copolymer type B; and a carbomer homopolymer type A; wherein the pharmaceutical composition is formulated as a lotion. 17. The topical pharmaceutical composition of claim 16, wherein the composition further comprises a humectant, one or more antimicrobial preservatives, a chelating agent, and a pH-adjusting agent. 18. A method for treating psoriasis, the method comprising topically applying a pharmaceutical composition to an affected area on a body of a subject suffering from psoriasis, wherein the composition comprises: halobetasol propionate at a concentration of 0.01 percent by weight of the composition; tazarotene at a concentration of 0.045 percent by weight of the composition; 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; and wherein the composition is capable of providing synergistic efficacy. 19. The method of claim 18, wherein said applying is carried out once daily for longer than two weeks. 20. The method of claim 19, wherein the method continues to provide relief for a period of four weeks after eight weeks of applying the composition to the affected area on the body of the subject. 21. The method of claim 18, wherein said applying is carried out once daily for twelve weeks. 22. The method of claim 18, wherein the halobetasol propionate is dissolved in the liquid oil component at room temperature, wherein the tazarotene is dissolved in the liquid oil component at room temperature, or wherein both the halobetasol propionate and the tazarotene are dissolved in the liquid oil component at room temperature. 23. The method of claim 18, wherein the liquid oil component comprises a dicarboxylic acid ester, a monocarboxylic ester, or a combination thereof. 24. The method of claim 23, wherein the liquid oil component comprises a dicarboxylic acid ester. 25. The method of claim 23, wherein the liquid oil component comprises a monocarboxylic acid ester. 26. The method of claim 23, wherein the liquid oil component further comprises mineral oil or light mineral oil. 27. The method of claim 23, wherein the liquid oil component further comprises light mineral oil. 28. The method of claim 18, wherein the composition further comprises one or more humectants, preservatives, chelating agents, emulsifying agents, thickening agents, and/or a pH adjusting agent. 29. The method of claim 28, wherein the composition further comprises an emulsifying agent. 30. The method of claim 18, wherein the composition is capable of providing a synergistic reduction is at least one adverse event, wherein the adverse event is selected from the group consisting of itching, burning, stinging, and combinations thereof.