Claims for Patent: 9,492,384

Summary for Patent: 9,492,384

Title:	Microemulsion and sub-micron emulsion process and compositions
Abstract:	An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of desonide is provided, along with a method of medical or cosmetic treatment of a dermal condition using the composition. The composition includes desonide; an oil phase dispersed throughout a water phase, the oil phase including at least one member selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane member, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol; and at least one lipophilic surfactant, the water phase including at least one hydrophilic surfactant and water; and a non-surfactant amphiphilic compound that is miscible in the water phase and added to the composition after formation of the microemulsion or sub-micron emulsion; wherein the desonide is in the water phase or both the water phase and the oil phase.
Inventor(s):	Larm; Maria Graziella (Rosanna, AU), Harding; Ronald (North Warrandyte, AU), Johnston; Michael (Yarraville, AU), Abram; Albert Zorko (Wantirna, AU), Viyayakumar; Prema (Fremont, CA), Sun; Phoebe (Mountain View, CA)
Assignee:	STIEFEL WEST COAST LLC (Wilmington, DE)
Application Number:	14/630,592
Patent Claims:	1. An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of desonide, the composition comprising: desonide; an oil in water microemulsion or sub-micron emulsion comprising an oil phase dispersed throughout a water phase, said oil phase comprising: at least one component selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol, and at least one lipophilic surfactant; and said water phase comprising: at least one hydrophilic surfactant, and water; and a non-surfactant amphiphilic compound that is added to the composition after formation of said microemulsion or sub-micron emulsion and is miscible in said water phase, wherein desonide is in said water phase or is in both said oil phase and said water phase. 2. The composition according to claim 1, wherein the weight ratio of said at least one hydrophilic surfactant to said at least one lipophilic surfactant is approximately 9.0:1.0 to 2.0:3.0. 3. The composition according to claim 1, wherein said oil phase comprises at least one component selected from the group consisting of mineral oil and petrolatum, and at least one lipophilic surfactant. 4. The composition according to claim 3, wherein said oil phase comprises a mixture of petrolatum and mineral oil, and at least one lipophilic surfactant. 5. The composition according to claim 1, wherein said amphiphilic compound is a water miscible organic solvent selected from the group consisting of an alcohol, a polyol, and mixtures thereof. 6. The composition according to claim 1, wherein said amphiphilic compound is selected from the group consisting of propylene glycol, phenoxy ethanol, and mixtures thereof. 7. The composition according to claim 1, wherein said surfactants have an aggregated HLB number between 8.0 and 15.0. 8. The composition according to claim 7, wherein said surfactants have an aggregated HLB number between 10 and 12. 9. The composition according to claim 8, wherein said surfactants have an aggregated HLB number between 9.7 and 11.8. 10. A method of medical or cosmetic treatment of a dermal condition comprising: applying to the skin of a patient requiring such treatment an effective amount of oil in water (O/W) microemulsion or sub-micron emulsion composition comprising: desonide; an oil in water microemulsion or sub-micron emulsion comprising an oil phase dispersed throughout a water phase, said oil phase comprising: at least one component selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol, and at least one lipophilic surfactant; and said water phase comprising: at least one hydrophilic surfactant, and water; and a non-surfactant amphiphilic compound that is added to said composition after formation of said microemulsion or sub-micron emulsion and is miscible in said water phase, wherein desonide is in said water phase or is in both said oil phase and said water phase. 11. The method according to claim 10, wherein the weight ratio of said at least one hydrophilic surfactant to said at least one lipophilic surfactant is approximately 9.0:1.0 to 2.0:3.0. 12. An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of desonide, the composition comprising: desonide; an oil in water microemulsion or sub-micron emulsion comprising an oil phase dispersed throughout a water phase, said oil phase comprising petrolatum and at least one lipophilic surfactant, said water phase comprising at least one hydrophilic surfactant and water; and a non-surfactant amphiphilic compound that is added to the composition after formation of said microemulsion or sub-micron emulsion and is miscible in said water phase, wherein desonide is in said water phase or is in both said oil phase and said water phase. 13. The method according to claim 12, wherein the weight ratio of said at least one hydrophilic surfactant to said at least one lipophilic surfactant is approximately 9.0:1.0 to 2.0:3.0.