Claims for Patent: 10,857,159

Summary for Patent: 10,857,159

Title:	Halobetasol foam composition and method of use thereof
Abstract:	The present invention provides a composition and method for treating various skin diseases. The composition is formulated as a foamable composition and includes the corticosteroid halobetasol.
Inventor(s):	Gauthier; Robert T. (San Diego, CA), Hammer; James D. (Uxbridge, MA)
Assignee:	MAYNE PHARMA LLC (Greenville, NC)
Application Number:	15/364,966
Patent Claims:	1. A storage stable, foamable composition consisting of, on a weight basis: a) 0.02 to 0.10% halobetasol or its pharmaceutically acceptable salts, esters, and solvates; b) 40 to 60% ethyl alcohol; c) 0.1 to 5.0% Emulsifying Wax, NF; d) 0.05 to 1.0% cetostearyl alcohol; e) 0.05 to 1.0% polyoxyl 20 cetostearyl ether; f) 1 to 10% propylene glycol; g) 30 to 40% water; h) greater than 0.0% and less than 0.0005% benzoic acid; and i) a propellant, wherein the composition has a pH of between about 4.0 to 6.3, and wherein an amount of degradation product of halobetasol is less than 2% after storage for 24 months at 25.degree. C. 2. The composition of claim 1, wherein the composition is present in a canister, and wherein the propellant is propane, n-butane, isobutane, or combinations thereof, at 3.25 to 5.75% w/w. 3. The composition of claim 2, wherein the propellant is present in an amount ranging from 3.5 to 4% w/w. 4. The composition of claim 1, wherein the composition has a pH of about 5.0-5.5.