Granted Patent
B2
US 12,453,721 · App. 17/821,051 · Granted Oct 28, 2025
Topical roflumilast aerosol foams
Assignee:
ARCUTIS BIOTHERAPEUTICS, INC.
A61K31/44A61K9/122A61K9/124A61K31/165A61K31/17A61K31/436A61K31/513A61K31/519A61K31/52A61K31/593A61K31/60A61K33/44A61K38/13A61K47/06A61K47/10A61K47/14A61K47/24
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Abstract
The present invention is directed to an aerosol foam composition comprising roflumilast, an emulsifier blend containing cetearyl alcohol, dicetyl phosphate, and ceteareth-10 phosphate and a hydrocarbon propellant. The aerosol foam composition is preferably an oil in water emulsion. The propellant is a mixture of liquefied hydrocarbon gases preferably a propane/isobutane/butane blend. The hydrocarbon propellant results in an aerosol foam which is stable, has consistent physical properties, excellent aesthetics, and no discernable degradation after long term or accelerated storage conditions.
Claims (42)
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.
2. 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 oil in water emulsion are in a ratio of about 1:8 to 1:6, and wherein the oil in water emulsion comprises:
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
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.
3. The aerosol foam according to claim 1 , wherein said hexylene glycol consists of 2.00% w/w to 4.00% w/w hexylene glycol.
4. The aerosol foam according to claim 3 , wherein said parabens consist of 0.2% (w/w) methylparaben and 0.05% (w/w) propylparaben.
5. The aerosol foam according to claim 2 , further comprising at least one additional component selected from the group consisting of a solvent, moisturizer, preservative, pH adjusting solution, and skin penetration enhancer.
6. The aerosol foam according to claim 2 , wherein said parabens comprises 0.2% (w/w) methylparaben and 0.05% (w/w) propylparaben.
7. The aerosol foam according to claim 1 , wherein said white petrolatum consists of 5% (w/w) white petrolatum.
8. The aerosol foam according to claim 1 , wherein said aerosol foam has a foam half-life of 30 seconds or more.
9. The aerosol foam according to claim 8 , wherein said aerosol foam has a half-life of 5 minutes or more.
10. The aerosol foam according to claim 9 , wherein said foam is white in color, and comprises bubbles of substantially uniform size.
11. The aerosol foam according to claim 9 , wherein said foam has a density less than 0.15 g/mL.
12. The aerosol foam according to claim 9 , wherein said foam retains at least 90% of roflumilast potency after 3 months of storage at 25° C.
13. The aerosol foam according to claim 9 , wherein said foam dispenses without sputtering.
14. The aerosol foam according to claim 1 , wherein said emulsifier blend consists of 2.0% (w/w) emulsifier blend.
15. The aerosol foam according to claim 14 , wherein said hexylene glycol consists of 2% (w/w) hexylene glycol.
16. The aerosol foam according to claim 15 , wherein said diethylene glycol monoethyl ether consists of 25.0% (w/w) diethylene glycol monoethyl ether.
17. The aerosol foam according to claim 16 , wherein said isopropyl palmitate consists of 2.5% (w/w) isopropyl palmitate.
18. The aerosol foam according to claim 17 , wherein said parabens consist of 0.2% (w/w) methylparaben and 0.05% (w/w) propylparaben.
19. The aerosol foam according to claim 18 , wherein said emulsion has a pH of 5.5.
Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE INVENTOR'S NAME PREVIOUSLY RECORDED AT REEL: 66490 FRAME: 527. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT.
Recorded Aug 4, 2025
From: OSBORNE, DAVID W.
To: ARCUTIS BIOTHERAPEUTICS, INC.
Reel/Frame 072916/0046 →
SECURITY INTEREST
Recorded Aug 9, 2024
From: ARCUTIS BIOTHERAPEUTICS, INC.
To: SLR INVESTMENT CORP.
Reel/Frame 068236/0418 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 19, 2024
From: OSBORNE, DAVID W., SR.
To: ARCUTIS BIOTHERAPEUTICS, INC.
Reel/Frame 066490/0527 →
Continuity (2)
Provisional Application
63294179
· Dec 28, 2021
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