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Last Updated: December 12, 2025

Claims for Patent: 12,076,403

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Summary for Patent: 12,076,403

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:	US17/993,799
Patent Claims:	1. A pharmaceutical composition for topical application to the skin of an individual, the composition comprising: a corticosteroid, wherein the corticosteroid is halobetasol propionate, and wherein the concentration of the corticosteroid is from about 0.01% w/w to about 0.03% w/w; 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., a dicarboxylic acid ester or a monocarboxylic ester, and a mineral oil or light mineral oil; and an aqueous component; wherein the pharmaceutical composition is formulated as a lotion, and wherein the concentration of the liquid oil component is between 1.0 and 3.0 times that required to completely solubilize the corticosteroid in the composition at a temperature of 22° C.±2° C. 2. The pharmaceutical composition of claim 1, wherein the concentration of the halobetasol propionate is about 0.01%. 3. The pharmaceutical composition of claim 1, wherein the liquid oil component comprises a dicarboxylic acid ester. 4. The pharmaceutical composition of claim 1, wherein the liquid oil component comprises a monocarboxylic acid ester. 5. The pharmaceutical composition of claim 1, wherein the liquid oil component further comprises mineral oil or light mineral oil. 6. The pharmaceutical composition 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. 7. The pharmaceutical composition 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. 8. The pharmaceutical composition 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. 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 10, wherein the emulsifying agent is sorbitan monooleate. 12. The pharmaceutical composition of claim 1, wherein the composition further comprises a pH adjusting agent. 13. The pharmaceutical composition of claim 1, wherein the composition maintains a VasoConstrictor Assay (VCA) score similar to the VCA score obtained by a formulation comprising 0.05% halobetasol propionate, cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, methylisothiazolinone, and water. 14. The pharmaceutical composition of claim 1, wherein the composition provides an equivalent or better efficacy in treating a dermatological disorder compared to that provided by a formulation comprising-0.05% halobetasol propionate, cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, methylisothiazolinone, and water. 15. The pharmaceutical composition of claim 14, wherein the dermatological disorder is psoriasis.

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