Granted Patent
B2
US 12,310,956 · App. 18/653,662 · Granted May 27, 2025
Topical roflumilast formulation having improved delivery and plasma half-life
Assignee:
ARCUTIS BIOTHERAPEUTICS, Inc.
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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.
Claims (27)
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.
Assignments (3)
SECURITY INTEREST
Recorded Aug 9, 2024
From: ARCUTIS BIOTHERAPEUTICS, INC.
To: SLR INVESTMENT CORP.
Reel/Frame 068236/0418 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 17, 2024
From: OSBORNE, DAVID W.
To: ARCUTIS, INC.
Reel/Frame 067446/0463 →
CHANGE OF NAME
Recorded May 17, 2024
From: ARCUTIS, INC.
To: ARCUTIS BIOTHERAPEUTICS, INC.
Reel/Frame 067456/0235 →
Continuity (9)
Continuation
15848505
· Dec 20, 2017
Continuation
15676356
· Aug 14, 2017
Division
15616409
· Jun 7, 2017
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