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.

1 - 60 . (canceled) 
     
     
         61 . A composition consisting essentially of:
 One or more corticosteroids,   Two or more penetration enhancers selected from the group consisting of diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexanetriol, and benzyl alcohol;   One or more of the group consisting of solvents and emulsifiers, and   One or more of group consisting of non-solvent/emulsifier ingredients, and
 wherein the penetration enhancers are present in a ratio to a total of the penetration enhancers, and solvents and emulsifiers of at least about 0.9, and 
 wherein the composition does not include a monoglyceride of a C 6 -C 10  medium chain fatty acid. 
   
     
     
         62 . The composition of  claim 61 , wherein the corticosteroid is present at about 0.10%. 
     
     
         63 . The composition of  claim 61 , wherein the corticosteroid is present at about 0.50%. 
     
     
         64 . The composition of  claim 61 , wherein the corticosteroid is present at about 0.25%. 
     
     
         65 . The composition of  claim 61 , wherein the ratio is at least about 0.95. 
     
     
         66 . The composition of  claim 61 , wherein the corticosteroid comprises a fluorinated corticosteroid. 
     
     
         67 . The composition of  claim 61 , wherein the corticosteroid comprises fluocinonide. 
     
     
         68 . The composition of  claim 61 , wherein the corticosteroid comprises fluocinolone acetonide. 
     
     
         69 . The composition of  claim 61 , 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, .α.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. 
     
     
         70 . The composition of  claim 61 , 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.