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Claims for Patent: 7,220,424

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Claims for Patent: 7,220,424

Title:Compositions and methods for enhancing corticosteroid delivery
Abstract:The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifiers. The propylene glycol and penetration enhancers are present in ratio to the total of the propylene glycol, penetration enhancers, and solvents and emulsifiers of at least about 0.70.
Inventor(s): Gans; Eugene H. (Westport, CT), Wortzman; Mitchell S. (Scottsdale, AZ)
Assignee: Medicis Pharmaceutical Corporation (Scottsdale, AZ)
Application Number:10/407,380
Patent Claims: 1. A method of delivering corticosteroids to skin comprising: Topically applying a composition comprising one or more corticosteroids with two or more penetration enhancers, and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90, and wherein the penetration enhancers comprise two or more of the group consisting of propylene glycol, diisopropyl adipate, dimethyl isosorbide, 1,2,6 hexanetriol, and benzyl alcohol.

2. A method of delivering corticosteroids to skin, comprising: Topically applying a composition comprising one or more corticosteroids with two or more penetration enhancers, and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90, and wherein the penetration enhancers comprise two or more of the group consisting of propylene glycol, diisopropyl adipate and dimethyl isosorbide.

3. A method of delivering corticosteroids to skin, comprising: Topically applying a composition compxisina one or more corticosteroids with two or more penetration enhancers, and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90, and wherein one penetration enhancer comprises propylene glycol.

4. The method of claim 1, wherein the corticosteroid comprises a fluorinated corticosteroid.

5. The method of claim 1, wherein the corticosteroid comprises fluocinonide.

6. The method of claim 1, wherein the corticosteroid comprises fluocinolone acetonide.

7. The method of claim 4, 5, 6, or 1, wherein the corticosteroid is present at about 0.10%.

8. The method of claim 4, 5, 6 or 1, wherein the corticosteroid is present at at least about 0.50%.

9. The method of claim 4, 5, 6, or 1, wherein the corticosteroid is present at at least about 0.25%.

10. The method of claim 1, 2, or 3, wherein the solvents and emulsifiers comprise one or more of the group consisting of dehydrated alcohol, alcohol (95% v/v)USP, 3-Cyclohexene-1-Methanol, 4-Dimethyl-a-(4-Methyl-3-Pentenyl)-, Steareth-2, Steareth-21, citric acid, CPE-215, diisopropanolamine (1:9), DIPA/PG (1:9), ethoxydiglycol, Potassium hydroxide (10%), PEG-40 Stearate, PEG-7000, Polysorbate 60, potassium hydroxide (1%), propylene carbonate USP, propylethylene glycol 4, oleyl alcohol, sodium lauryl sulfate, sorbitan monostearate, sorbitan stearate, and 1,2,3-Propanetriyl Ester.

11. The method of claim 1, 2, or 3, wherein the composition further comprises one or more non-solvent/emulsifier ingredients.

12. The method of claim 11 wherein the non-solvent/emulsifier ingredients comprise one or more of the group consisting of Glyceryl Stearate (and) PEG-100 Stearate, carbopol 980, cyclomethicone NP, glyceryl monostearate, hydroxyethyl cellulose, hydroxypropyl cellulose, isopropyl myristate, methyl paraben NF, mineral oil, oleic acid NF, PEG-100 Stearate, petrolatum, propyl paraben NF, purified water, stearyl alcohol, white petrolatum, and white wax.

13. The method of claim 1, 2, or 3, wherein the solvents and emulsifiers are present at about 4-5%.

14. The method of claim 12 wherein the non-solvent/emulsifier ingredients are present at about 11% to about 53%.

15. The method of claim 12 wherein the non-solvent/emulsifier ingredients are present at about 11% to about 27%.
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