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Claims for Patent: 6,765,001

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Claims for Patent: 6,765,001

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:10/037,360
Patent Claims: 1. A composition comprising One or more corticosteroids, wherein one corticosteroid comprises fluocinonide; Two or more penetration enhancers selected from the group consisting of diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexapetriol, and benzyl alcohol; and one or more of the group consisting of solvents and emulsifiers, wherein the penetration enhancers are present in a ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.90.

2. The composition of claim 1, wherein the corticosteroid is present at about 0.10%.

3. The composition of claim 1, wherein the corticosteroid is present at about 0.50%.

4. The composition of claim 1, wherein the corticosteroid is present at about 0.25%.

5. The composition of claim 1, wherein the penetration enhancers comprise two or more of the group consisting of propylene glycol, diisopropyl adipate and dimethyl isosorbide.

6. The composition of claim 1, wherein one penetration enhancer comprises propylene glycol.

7. The composition of claim 1 wherein the ratio is at least about 0.95.

8. The composition of claim 1 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, .varies.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.

9. The composition of claim 1 further comprising one or more non-solvent/emulsifier ingredients.

10. The composition of claim 9 wherein the non-solvent/emulsifier ingredients comprise one or more of the group consisting of Glyceryl Stearate (and) PEG-100 Stearate, carbopol 980, cyclomethicone NF, 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.

11. The composition of claim 1 wherein the solvents and emulsifiers are present at about 4-about 5%.

12. The composition of claim 9 wherein the non-solvent/emulsifier ingredients are present at about 11% to about 53%.

13. The composition of claim 9 wherein the non-solvent/emulsifier ingredients are present at about 11% to about 27%.

14. A composition comprising about 0.10% fluocinonide, about 74.9% propylene glycol, about 3.0% diisopropyl adipate, about 5.0% isopropyl myristate, about 2.5% 1,2,6 trihydroxyhexane, about 1.0% carbopol 980, about 1.0% diisopropanolamine 85%: propylene glycol (1:9), about 0.01% citric acid, about 2.49% purified water, about 2.5% glyceryl monostearate, and about 7.5% glyceryl monostearate & PEG stearate.

15. A composition comprising about 0.10% fluocinonide, about 70.0% propylene glycol, about 15.0% dimethyl isosorbide, about 1.2% carbopol 980, about 1.2% diisopropanolamine 85%: propylene glycol (1:9), about 0.01% citric acid, about 2.49% purified water, about 2.5% glyceryl monostearate, and about 7.5% glyceryl monostearate & PEG stearate.

16. A composition comprising about 0.10% fluocinonide, about 66.8% propylene glycol, about 5.0% dimethyl isosorbide, about 5.0% isopropyl myristate, about 0.5% carbopol 980, about 0.5% diisopropanolamine 85%: propylene glycol (1:9), about 5.0% white petrolatum USP, about 60% glyceryl monostearate, about 6.0% PEG 100 stearate, about 5.0% stearyl alcohol, and about 0.10% sodium lauryl sulfate.

17. A composition comprising about 0.10% fluocinonide, about 69.9% propylene glycol, about 2.0% diisopropyl adipate, about 5.0% isopropyl myristate, about 0.5% carbopol 980, about 0.5% diisopropanolamine 85%: propylene glycol (1:9), about 5.0% white petrolatum USP, about 6.0% glyceryl monostearate, about 6.0% PEG 100 stearate, and about 5.0% stearyl alcohol.
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