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Last Updated: December 19, 2025

Claims for Patent: 12,310,956

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Summary for Patent: 12,310,956

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:	US18/653,662
Patent Claims:	1. A method of treating inflammatory dermatoses comprising topically administering a pharmaceutical composition comprising: (i) roflumilast in an amount of 0.05-1.0% w/w; (ii) diethylene glycol monoethyl ether; and (iii) an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; and (iv) water, wherein the composition is administered once daily. 2. The method according to claim 1, wherein said composition comprises 1.0-25% w/w of said emulsifier blend. 3. The method according to claim 2, wherein said composition is a cream, and wherein said composition comprises 2.5-20% w/w of said emulsifier blend. 4. The method according to claim 3, wherein said composition comprises 5-15% w/w of said emulsifier blend. 5. The method according to claim 4, wherein said composition comprises 10% w/w of said emulsifier blend. 6. The method according to claim 2, wherein said composition is a foam, and wherein said composition comprises 1.0-10% w/w of said emulsifier blend. 7. The method according to claim 6, wherein said composition comprises 2% w/w of said emulsifier blend. 8. The method according to claim 1, wherein said composition comprises 10-30% w/w diethylene glycol monoethyl ether. 9. The method according to claim 8, wherein said composition comprises 25% w/w diethylene glycol monoethyl ether. 10. The method according to claim 1, wherein said inflammatory dermatoses is psoriasis. 11. The method according to claim 10, wherein said composition is applied to psoriasis lesions in intertriginous areas. 12. The method according to claim 11, wherein said composition comprises 1.0-25% w/w of said emulsifier blend and 10-30% w/w diethylene glycol monoethyl ether. 13. The method according to claim 12, wherein said composition comprises 10% w/w of said emulsifier blend. 14. The method according to claim 10, wherein said composition is applied to psoriasis lesions on the scalp. 15. The method according to claim 14, wherein said composition comprises 1.0-25% w/w of said emulsifier blend and 10-30% w/w diethylene glycol monoethyl ether. 16. The method according to claim 15, wherein said composition comprises 2% w/w of said emulsifier blend. 17. The method according to claim 1, wherein said inflammatory dermatoses is atopic dermatitis. 18. The method according to claim 17, wherein said composition comprises 1.0-25% w/w of said emulsifier blend and 10-30% w/w diethylene glycol monoethyl ether. 19. The method according to claim 18, wherein said composition comprises 10% w/w of said emulsifier blend. 20. The method according to claim 1, wherein said inflammatory dermatoses is seborrheic dermatitis. 21. The method according to claim 20, wherein said composition comprises 1.0-25% w/w of said emulsifier blend and 10-30% w/w diethylene glycol monoethyl ether. 22. The method according to claim 21, wherein said composition comprises 2% w/w of said emulsifier blend.

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