Topical compositions comprising a corticosteroid

Abstract

Topical compositions comprising a corticosteroid and at least one penetration enhancing agent, wherein the composition is substantially free of propylene glycol.

1 . A topical composition for improving therapeutic efficacy and/or reducing the adverse effect of clobetasol comprising:
 a) a low dose of clobetasol;   b) an oil phase comprising at least one penetration enhancing agent, and a non-polymeric thickening agent; and   c) an aqueous phase;   
       wherein the said topical composition is substantially free of propylene glycol and substantially free of polymers. 
     
     
         2 . The topical composition according to  claim 1 , and further comprising a pharmaceutically acceptable excipient. 
     
     
         3 . The topical composition according to  claim 1 , wherein the adverse effect is on the endocrine system. 
     
     
         4 . The topical composition according to  claim 1 , wherein the adverse effect is hypothalamic pituitary adrenal (HPA) axis suppression. 
     
     
         5 . The topical composition according to  claim 1 , wherein the clobetasol is clobetasol propionate. 
     
     
         6 . The topical composition according to the  claim 5 , wherein the clobetasol propionate is present in an amount from about 0.005% to about 0.1% of the total weight of the composition. 
     
     
         7 . The topical composition according to the  claim 5 , wherein the clobetasol propionate is present in an amount from about 0.005% to about 0.05% of the total weight of the composition. 
     
     
         8 . The topical composition according to the  claim 5 , wherein the clobetasol propionate is present in an amount up to about 0.025% of the total weight of the composition. 
     
     
         9 . The topical composition according to  claim 1 , wherein the said penetration enhancing agent selected from mineral oil, isopropyl myristate, dimethyl isosorbide, oleyl alcohol, labrafil, labrasol, medium chain triglyceride, diethyl sebacate, ammonium lauryl sulfate, lauramine oxide, sodium laureth sulfate, n-methyl-2-pyrrolidinone, octanoic_acid, cocobetaine, dimethylsulfoxide, sodium laureth 2 sulfate, benzyl_alcohol, ethylacetate, lactic acid, oleic acid, ethylacetate, spearmint oil, isostearic acid, ethanol, propylene glycol diacetate, dimethyl isosorbide, 1-butanol, methyl gluceth-10, sodium lauroylsarcosinate, polysorbate 20, isopropyl alcohol, 1-butanol, Capryol 90, sorbitanmonooleate, glyceryl ricinoleate, poloxamer, polyethylene glycol 200, polysorbate 65, triacetin, benzylalcohol, castor oil, arlacel 165, propylene glycol ricinoleate, glyceryl isostearate, propylene glycol, diethyl phthalate, glyceryl oleate, PEG-8 laurate, sorbitan sesquioleate, PPG-26 oleate, 1-octanol, Lauroglycol_FCC, diisopropyladipate, laureth 4, and diethyl sebacate. 
     
     
         10 . The topical composition according to  claim 2 , wherein the said penetration enhancing agent selected from mineral oil, isopropyl myristate, dimethyl isosorbide, oleyl alcohol, labrafil, labrasol, medium chain triglyceride, diethyl sebacate, ammonium lauryl sulfate, lauramine oxide, sodium laureth sulfate, n-methyl-2-pyrrolidinone, octanoic_acid, cocobetaine, dimethylsulfoxide, sodium laureth 2 sulfate, benzyl_alcohol, ethylacetate, lactic acid, oleic acid, ethylacetate, spearmint oil, isostearic acid, ethanol, propylene glycol diacetate, dimethyl isosorbide, 1-butanol, methyl gluceth-10, sodium lauroylsarcosinate, polysorbate 20, isopropyl alcohol, 1-butanol, Capryol 90, sorbitanmonooleate, glyceryl ricinoleate, poloxamer, polyethylene glycol 200, polysorbate 65, triacetin, benzylalcohol, castor oil, arlacel 165, propylene glycol ricinoleate, glyceryl isostearate, propylene glycol, diethyl phthalate, glyceryl oleate, PEG-8 laurate, sorbitan sesquioleate, PPG-26 oleate, 1-octanol, Lauroglycol_FCC, diisopropyladipate, laureth 4, and diethyl sebacate. 
     
     
         11 . The topical composition according to  claim 3 , wherein the said penetration enhancing agent selected from mineral oil, isopropyl myristate, dimethyl isosorbide, oleyl alcohol, labrafil, labrasol, medium chain triglyceride, diethyl sebacate, ammonium lauryl sulfate, lauramine oxide, sodium laureth sulfate, n-methyl-2-pyrrolidinone, octanoic_acid, cocobetaine, dimethylsulfoxide, sodium laureth 2 sulfate, benzyl_alcohol, ethylacetate, lactic acid, oleic acid, ethylacetate, spearmint oil, isostearic acid, ethanol, propylene glycol diacetate, dimethyl isosorbide, 1-butanol, methyl gluceth-10, sodium lauroylsarcosinate, polysorbate 20, isopropyl alcohol, 1-butanol, Capryol 90, sorbitanmonooleate, glyceryl ricinoleate, poloxamer, polyethylene glycol 200, polysorbate 65, triacetin, benzylalcohol, castor oil, arlacel 165, propylene glycol ricinoleate, glyceryl isostearate, propylene glycol, diethyl phthalate, glyceryl oleate, PEG-8 laurate, sorbitan sesquioleate, PPG-26 oleate, 1-octanol, Lauroglycol_FCC, diisopropyladipate, laureth 4, and diethyl sebacate. 
     
     
         12 . The topical composition according to  claim 1 , wherein the penetration enhancing agent is present in an amounts from about 1% to about 30.0% of the total weight of the composition. 
     
     
         13 . The topical composition according to  claim 1 , the said non-polymeric thickening agent selected from cetyl alcohol, paraffin, stearyl alcohol, white wax, wax cetyl esters, microcrystalline wax, anionic emulsifying wax, nonionic emulsifying wax, yellow wax, castor oil, ceresin, cetostearyl alcohol, cyclomethicone, glyceryl behenate, hectorite, myristyl alcohol, cetylstearyl alcohol, triolein, and lanolin. 
     
     
         14 . The topical composition according  claim 1 , comprising at least 60% w/w aqueous phase by weight based on the total weight of the composition. 
     
     
         15 . The topical composition according  claim 2 , comprising at least 60% w/w aqueous phase by weight based on the total weight of the composition. 
     
     
         16 . The topical composition according  claim 3 , comprising at least 60% w/w aqueous phase by weight based on the total weight of the composition. 
     
     
         17 . A topical composition for improving therapeutic efficacy and/or reducing the adverse effect of clobetasol comprising:
 a) a low dose of about 0.025% w/w of clobetasol or its pharmaceutically acceptable salts thereof;   b) an oil phase comprising at least one penetration enhancing agent comprising isopropyl myristate in the percentage of less than about 15% w/w, and a non-polymeric thickening agent comprising: cetostearyl alcohol; and   c) an aqueous phase comprising water at least about 60% w/w;   
       wherein the said topical composition is substantially free of propylene glycol and substantially free of polymers. 
     
     
         18 . A topical composition for improving therapeutic efficacy and/or reducing the adverse effect of clobetasol comprising:
 a) a low dose of about 0.025% w/w clobetasol;   b) an oil phase comprising at least one penetration enhancing agent, and a non-polymeric thickening agent; and   c) an aqueous phase;   
       wherein the said topical composition is substantially free of propylene glycol and substantially free of polymers.