Claims for Patent: 11,819,496

Summary for Patent: 11,819,496

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:	US18/176,601
Patent Claims:	1. A method of treating a patient suffering from psoriasis comprising: topically administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of roflumilast, diethylene glycol monoethyl ether, and an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said composition comprises an amount of said emulsifier blend sufficient to increase the plasma half-life of roflumilast, and wherein the plasma half-life of the roflumilast is between about 3 and about 5 days. 2. The method according to claim 1, wherein said composition comprises 0.1% to 0.5% w/w roflumilast. 3. The method according to claim 2, wherein said composition is a cream or foam. 4. The method according to claim 1, wherein the plasma half-life of the roflumilast is between about 3 and about 4 days. 5. The method according to claim 1, wherein said composition comprises about 10% w/w of said emulsifier blend. 6. The method according to claim 1, wherein said composition comprises about 25% w/w diethylene glycol monoethyl ether. 7. The method according to claim 1, wherein said roflumilast is in an amount of 0.1% to 0.5% w/w, said emulsifier blend is in an amount of 10% w/w and said diethylene glycol monoethyl ether is in an amount of 25% w/w, and wherein said composition is a cream. 8. The method according to claim 1, wherein said roflumilast is in an amount of 0.1% to 0.5% w/w, said emulsifier blend is in an amount of 10% w/w and said diethylene glycol monoethyl ether is in an amount of 25% w/w, and wherein said composition is a foam. 9. A method of treating a patient suffering from inflammatory dermatoses comprising: topically administering to said patient a pharmaceutical composition comprising a therapeutically effective amount of roflumilast, diethylene glycol monoethyl ether, and an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said composition comprises an amount of emulsifier blend sufficient to increase the plasma half-life of roflumilast, and wherein the plasma half-life of the roflumilast is between about 3 and about 5 days. 10. The method according to claim 9, wherein said composition comprises 0.05% to 1% w/w roflumilast. 11. The method according to claim 9, wherein said composition is a cream or a foam. 12. The method according to claim 9, wherein the plasma half-life of the roflumilast is between about 3 and about 4 days. 13. The method according to claim 9, wherein said composition comprises about 10% w/w of said emulsifier blend. 14. The method according to claim 9, wherein said composition comprises about 25% w/w diethylene glycol monoethyl ether. 15. The method according to claim 9, wherein said patient is suffering from atopic dermatitis. 16. The method according to claim 15, wherein said roflumilast is in an amount of 0.05% to 1% w/w, said emulsifier blend is in an amount of 10% w/w, said diethylene glycol monoethyl ether is in an amount of 25% w/w, and wherein said composition is a cream. 17. The method according to claim 9, wherein said roflumilast is in an amount of 0.1% to 0.5% w/w, said emulsifier blend is in an amount of 10% w/w and said diethylene glycol monoethyl ether is in an amount of 25% w/w, and wherein said composition is a foam. 18. A method of treating a patient suffering from inflammatory dermatoses comprising: topically administering to said patient once daily a composition comprising a therapeutically effective amount of roflumilast, diethylene glycol monoethyl ether, and an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said therapeutically effective amount of roflumilast is 0.05% to 1% w/w, wherein said composition comprises an amount of said emulsifier blend sufficient to increase the plasma half-life of roflumilast, wherein the plasma half-life of roflumilast is between about 3 and about 5 days, and wherein the roflumilast remains at a therapeutically effective level after a patient misses one dose. 19. The method according to claim 18, wherein said composition is a cream or foam. 20. The method according to claim 18, wherein said emulsifier blend is in an amount of 10% w/w and said diethylene glycol monoethyl ether is in an amount of 25% w/w.