Patent ID: 8551504

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 propylene glycol, ethylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol monoethyl ether, dipropylene glycol, propylene glycol dipelargonate, propylene glycol laurate, ethoxydiglycol and propylene glycol dicaprate/dicaprylate and 1% to 20% of at least one additional pro-penetrating agent selected from the group consisting of propylene glycol, dipropylene glycol, propylene glycol dipelargonate, propylene glycol laurate, ethoxydiglycol, propylene glycol dicaprate-dicaprylate, 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) 0.1% to 5% of at least one gelling agent selected from the group consisting of xanthan gum, carob gum, guar gum, alginates, hydroxyethylcellulose, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, carbomers and starch derivatives, and mixtures thereof, said at least one gelling agent being the only gelling agent(s) in the composition; (d) 0.1% to 5% of at least one emulsifier which is selected from the group consisting of polyglyceryl esters of isostearic acid, sorbitan isostearate, sorbitan sesquioleate, sorbitan laurate, glycol esters of isostearic acid, sorbitol esters of oleic acid, glycol esters of oleyl alcohol, oxyethylenated sorbitan monostearate, stearyl alcohol and cetyl alcohol, said at least one emulsifier being the only emulsifier(s) in the composition; (e) an oil, (f) water, and (g) 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, and wherein all percents are by weight with respect to the total weight of the composition.