Topical formulations comprising a steroid

Abstract

The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.

1 .- 10 . (canceled) 
     
     
         11 . A propellant-free sprayable topical pharmaceutical composition, comprising a steroid, an emulsifying agent, a polymer, water, a water-immiscible substance, and a penetration enhancer. 
     
     
         12 . The composition according to  claim 11 , wherein the penetration enhancer is in an amount of about 0.001-15 percent by weight. 
     
     
         13 . The composition according to  claim 11 , wherein a steroid is selected from the group comprising alclometasone dipropionate, beclomethasone dipropionate, betamethasone dipropionate, betamethasone valerate, fluocinolone acetonide, halobetasol propionate, hydrocortisone aceponate, hydrocortisone acetate, hydrocortisone valerate, hydrocortisone butyrate, mometasone furoate, triamcinolone acetonide, clocortolone pivalate, clobetasol propionate, desoximetasone, or fluticasone propionate. 
     
     
         14 . The composition according to  claim 11 , wherein a penetration enhancer is selected from the group comprising a polyol and esters, ethers, sulfoxides, fatty acids, fatty acid esters, or any combination thereof. 
     
     
         15 . The composition according to  claim 14 , wherein a penetration enhancer is selected from the group comprising polyethylene glycol, butanediol, polyethylene glycol monolaurate, diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, dimethylsulfoxide, decylmethylsulfoxide, lauric acid, oleic acid, valeric acid, isopropyl myristate, isopropyl palmitate, methyl propionate, ethyl oleate, or any combination thereof. 
     
     
         16 . The composition according to  claim 11 , wherein a water-immiscible substance is selected from the group comprising vegetable oil, saturated paraffin oil, mineral oil, fatty acid, fatty ester of a natural fatty acid, triglyceride of animal or vegetable origin, medium chain triglyceride, mixture of mono-, di- and/or tri-glycerides, wax, hydrogenated vegetable oil, or any combination thereof. 
     
     
         17 . The composition according to  claim 11 , wherein an emulsifying agent is selected from the group comprising cationic surfactant, anionic surfactant, zwitterionic surfactant, amphoteric surfactant, or any combination thereof. 
     
     
         18 . The composition according to  claim 17 , wherein an emulsifying agent is selected from the group comprising a sorbitan fatty acid ester, a mixture of partial esters of sorbitol and its mono- and di-anhydrides with fatty acids, a polyethylene glycol stearate, a glycol stearate, sodium lauryl sulphate, cetyl trialkyl ammonium bromide, a polyoxyethylene sorbitan fatty acid ester, or any combination thereof. 
     
     
         19 . The composition according to  claim 11 , wherein a polymer is selected from the group comprising polyethylene glycol, acrylate polymer, methacrylate polymer, polyvinylpyrrolidone, copolymer based on butyl methacrylate and methyl methacrylate, vinyl acetate, polyvinyl acetate, ethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxybutyl methyl cellulose, xanthan gum, tragacanth, guar gum, locust bean gum, acacia, alginate, cellulose acetate phthalate, cellulose acetate butyrate, hydroxypropyl methylcellulose phthalate, or any combination thereof. 
     
     
         20 . The composition according to  claim 11 , is substantially free of either or both of an alcohol and propylene glycol. 
     
     
         21 . The composition according to  claim 11 , is substantially non-foaming. 
     
     
         22 . The composition according to  claim 11 , is an aqueous-based emulsion. 
     
     
         23 . The composition according to  claim 11 , which, after spraying, does not form an occlusive film on a site of skin application. 
     
     
         24 . A propellant-free sprayable topical pharmaceutical composition, comprising a betamethasone compound, in amounts equivalent to about 0.025 to about 0.1 percent by weight of betamethasone base, an emulsifying agent, a polymer, water, a water-immiscible substance, and a penetration enhancer. 
     
     
         25 . The composition of  claim 24 , wherein the penetration enhancer is in an amount of about 0.001 to about 15 percent by weight. 
     
     
         26 . The composition of  claim 24 , wherein a betamethasone compound is betamethasone benzoate, betamethasone dipropionate, betamethasone sodium phosphate, or betamethasone valerate. 
     
     
         27 . The composition according to  claim 11 , for treating one or more of atopic dermatitis, seborrhoeic dermatitis, eczema, plaque psoriasis, erythroderma psoriasis, and psoriasis of the scalp, steroid responsive dermatoses, erythema, or contact sensitivity reactions, and other associated diseases or disorders. 
     
     
         28 . The composition according to  claim 24 , for treating one or more of atopic dermatitis, seborrhoeic dermatitis, eczema, plaque psoriasis, erythroderma psoriasis, and psoriasis of the scalp, steroid responsive dermatoses, erythema, or contact sensitivity reactions, and other associated diseases or disorders.