Granted Patent B2

US 12,589,100 · App. 16/544,070 · Granted Mar 31, 2026

Inventors: Robert T. Gauthier (San Diego, CA); James D. Hammer (Uxbridge, MA); Wayne S. Alden, IV (San Diego, CA)

Assignee: MAYNE PHARMA LLC

A61K31/573A61K9/0014A61K9/122A61K47/10A61K47/12A61K47/44

Abstract

Claims (18)

1 . A storage stable, foamable composition comprising 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) 3.25 to 5.75% propellant, wherein the composition has a pH of between about 4.0 to 6.3, and wherein the composition is produced by:

forming a homogenous solution including (b)-(h), wherein the solution is formed at a temperature of at least about 65° C.;

cooling the homogenous solution to a temperature of below about 50° C.;

adding halobetasol, or a pharmaceutically acceptable salt, ester, or solvate thereof, to the cooled solution and forming a homogenous solution;

filling an aerosol canister with the homogenous solution while the solution is at a temperature of above about 35° C.; and

charging the canister with the propellant thereby forming the foamable composition;

wherein the composition is stable for greater than 36 months at 25° C., regardless of whether or not the composition is void of a buffer, as determined by assay of an active amount of halobetasol.

2 . The composition of claim 1 , wherein the aerosol canister is filled with the homogenous solution while the solution is at a temperature of above about 42° C.

3 . The composition of claim 1 , wherein the propellant is propane, n-butane, isobutane, or combinations thereof, at 3.25 to 5.75% w/w.

Assignments (3)

Continuity (3)

References Cited (11)