Patent ID: 8551503

Claim:
A topically applicable, pharmaceutical composition comprising a physically and chemically stable oil-in-water emulsion which comprises: (a) 0.0025% to 0.5% of clobetasol propionate, said clobetasol propionate being the only active ingredient in the composition; (b) a pro-penetrating system which consists of 30% to 50% of at least one glycol selected from the group consisting of ethylene glycol, polyethylene glycol, propylene glycol, dipropylene glycol, butylene glycol, pentylene glycol, hexylene glycol, propylene glycol dipelargonate, diethylene glycol monoethyl ether, propylene glycol laurate, propylene glycol dicaprate dicaprylate and ethoxydiglycol; and 1% to 20% of at least one additional pro-penetrating agent selected from the group consisting of ethylene glycol, polyethylene glycol, propylene glycol, dipropylene glycol, butylene glycol, pentylene glycol, hexylene glycol, propylene glycol dipelargonate, diethylene glycol monoethyl ether, propylene glycol laurate, propylene glycol dicaprate dicaprylate, ethoxydiglycol, ethanol, dimethyl isosorbide, methylpyrrolidone, oleic acid, PEG-8 capric/caprylic glycerides and oleyl alcohol; said pro-penetrating system being the only pro-penetrating system in the composition; (c) an emulsifier which consists of 0.1% to 5% of at least one polymeric emulsifier which is selected from the group consisting of ammonium acryloyldimethyltaurate/VP copolymer and acrylates/steareth-20 methacrylate copolymer, said emulsifier being the only emulsifier(s) in the composition; (d) an oil, (e) water, and (f) optionally, sodium hydroxide, for adjusting the pH of the emulsion to from 5 to 7.5; said composition being devoid of any copolymer comprising a major fraction of acrylic acid and a minor fraction of C 10 -C 30 (meth) acrylic acid esters, wherein all percents are by weight with respect to the total weight of the composition.