Claims for Patent: 12,005,052

Summary for Patent: 12,005,052

Title:	Topical roflumilast formulation having improved delivery and plasma half-life
Abstract:	The present invention is directed to methods for improving the therapeutic outcome of treatment with roflumilast. The therapeutic outcome is improved by consistent delivery and/or a longer plasma half-life of a topically administered roflumilast composition. The roflumilast composition preferably includes dicetyl phosphate, ceteth-10 phosphate, diethylene glycol I monoethyl ether, and/or hexylene glycol.
Inventor(s):	David W. Osborne
Assignee:	Arcutis Biotherapeutics Inc
Application Number:	US18/353,869
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,005,052
Patent Claims:	1. A pharmaceutical composition for topical administration comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1.0% w/w; (ii) water; (iii) diethylene glycol monoethyl ether; and (iv) an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; wherein the plasma half-life of the roflumilast is between 3 and 5 days after topical administration of the composition. 2. The composition according to claim 1, wherein said composition comprises about 10% w/w of said emulsifier blend. 3. The composition according to claim 1, wherein said composition comprises about 25% w/w diethylene glycol monoethyl ether. 4. The composition according to claim 1, wherein said composition comprises w/w roflumilast. 5. The composition according to claim 4, wherein said composition comprises about 10% w/w of said emulsifier blend. 6. The composition according to claim 4, wherein said composition comprises about 25% diethylene glycol monoethyl ether. 7. A pharmaceutical composition for topical administration comprising: (i) roflumilast in an amount of 0.05-1.0% w/w; (ii) water qs ad 100% w/w; (iii) diethylene glycol monoethyl ether in an amount of 10-30% w/w; and (iv) an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in an amount of 1.0-25% w/w; wherein the composition is a foam or cream. 8. The composition according to claim 7, wherein said composition is a foam, and wherein said composition comprises 25% w/w diethylene glycol monoethyl ether, 2% w/w emulsifier blend, white petrolatum, and isopropyl palmitate. 9. The composition according to claim 7, wherein said composition is a cream, and wherein said composition comprises 25% w/w diethylene glycol monoethyl ether, 10% w/w emulsifier blend, 10.0% w/w white petrolatum, and 5.0% w/w isopropyl palmitate.