	US 12,453,721 B2
	Topical roflumilast aerosol foams
David W. Osborne, Fort Collins, CO (US)
Assigned to ARCUTIS BIOTHERAPEUTICS, INC., Westlake Village, CA (US)
Filed by ARCUTIS BIOTHERAPEUTICS, INC., Westlake Village, CA (US)
Filed on Aug. 19, 2022, as Appl. No. 17/821,051.
Claims priority of provisional application 63/294,179, filed on Dec. 28, 2021.
Prior Publication US 2023/0201177 A1, Jun. 29, 2023
Int. Cl. A61K 31/44 (2006.01); A61K 9/12 (2006.01); A61K 31/165 (2006.01); A61K 31/17 (2006.01); A61K 31/436 (2006.01); A61K 31/513 (2006.01); A61K 31/519 (2006.01); A61K 31/52 (2006.01); A61K 31/593 (2006.01); A61K 31/60 (2006.01); A61K 33/44 (2006.01); A61K 38/13 (2006.01); A61K 47/06 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/24 (2006.01)

CPC A61K 31/44 (2013.01) [A61K 9/122 (2013.01); A61K 9/124 (2013.01); A61K 31/165 (2013.01); A61K 31/17 (2013.01); A61K 31/436 (2013.01); A61K 31/513 (2013.01); A61K 31/519 (2013.01); A61K 31/52 (2013.01); A61K 31/593 (2013.01); A61K 31/60 (2013.01); A61K 33/44 (2013.01); A61K 38/13 (2013.01); A61K 47/06 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/24 (2013.01)]

19 Claims

1. An aerosol foam comprising an oil-in-water emulsion and a 55:15:30 propane/isobutane/butane propellant blend,

wherein said oil-in-water emulsion has a viscosity of 4,000-11,000 cP,

wherein said propellant and said oil-in-water emulsion are in a ratio of about 1:8 to 1:6, and

wherein the oil in water emulsion consists of:

Roflumilast 0.3% w/w

White Petrolatum 2-6% w/w

Isopropyl Palmitate 2-3% w/w

Emulsifier blend comprising cetearyl alcohol, dicetyl phosphate, and ceteareth-10

phosphate 2-4% w/w

Hexylene glycol 0-4% w/w

Diethylene glycol monoethyl ether 25-35% w/w

Paraben preservative(s)

pH Modifier q.s. ad pH 5.5-6.0

Purified Water q.s. ad 100.