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Claims for Patent: 8,962,000

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Claims for Patent: 8,962,000

Title:Microemulsion and sub-micron emulsion process and compositions
Abstract: An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, is provided. The composition includes 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, water and optionally a non-surfactant amphiphilic compound, the weight ratio of the at least one hydrophilic surfactant to the at least one lipophilic surfactant being approximately 9.0:1.0 to 2.0:3.0.
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:13/873,777
Patent Claims: 1. An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, the composition comprising: at least one pharmaceutically active ingredient; 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, 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 said pharmaceutically active ingredient is in said water phase or is in both said oil phase and said water phase, and 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.

2. The composition according to claim 1, wherein said oil phase comprises at least one occlusive agent selected from the group consisting of mineral oil and petrolatum, and at least one lipophilic surfactant.

3. The composition according to claim 2, wherein said oil phase comprises a mixture of petrolatum and mineral oil, and at least one lipophilic surfactant.

4. 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.

5. The composition according to claim 1, wherein said surfactants have an aggregated HLB number between 8.0 and 15.0.

6. The composition according to claim 5, wherein said surfactants have an aggregated HLB number between 10 and 12.

7. The composition according to claim 6, wherein said surfactants have an aggregated HLB number between 9.7 and 11.8.

8. The composition according to claim 1, wherein said pharmaceutically active ingredient is one or more water insoluble compounds selected from the group consisting of corticosteroids, vitamin D analogues, and vitamin A analogues.

9. The composition according to claim 8, wherein said pharmaceutically active ingredient is a corticosteroid.

10. The composition according to claim 9, wherein said corticosteroid is selected from the group consisting of desonide, clobetasol propionate, and betamethasone valerate.

11. 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: at least one pharmaceutically active ingredient; 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, 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 said pharmaceutically active ingredient is in said water phase or is in both said oil phase and said water phase, and 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. The method according to claim 11, wherein said patient is a human.

13. The composition according to claim 4, wherein said amphiphilic compound is selected from the group consisting of propylene glycol, phenoxy ethanol, and mixtures thereof.

14. An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, the composition comprising: at least one pharmaceutically active ingredient which is a corticosteroid; 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 said corticosteroid is in said water phase or is in both said oil phase and said water phase, and 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.
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