IP Library Granted Patent US 12,042,558
Granted Patent B2
US 12,042,558 · App. 16/426,492 · Granted Jul 23, 2024

Method and formulation for improving roflumilast skin penetration lag time

Inventor: David W. Osborne (Fort Collins, CO)
Assignee: ARCUTIS BIOTHERAPEUTICS, INC.
A61K9/0014A61K9/06A61K9/107A61K31/122A61K31/17A61K31/194A61K31/366A61K31/44A61K31/52A61K31/5377A61K31/573A61K31/60A61K47/10A61K47/14A61K47/24A61K47/6903A61P17/06A61K45/06
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Quick Facts
Patent No.
US 12,042,558
App. No.
16/426,492
Granted
Jul 23, 2024
Kind
B2
Abstract

Decreasing skin penetration lag times will improve the bioavailability of a topically administered roflumilast composition. A shorter skin penetration lag time provides quicker onset of disease relief and more consistent bioavailability as there is less transference to clothing or other people. The skin penetration lag time for roflumilast can be reduced by formulating a roflumilast composition to have a pH between 4.0-6.5 and/or combining roflumilast with an emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate.

Claims (6)

1. A method for reducing roflumilast skin penetration lag time in a patient, comprising topically administering a composition comprising roflumilast diethylene glycol monoethyl ether and an emulsifier blend to said patient, wherein said emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said composition does not include hexylene glycol, wherein said roflumilast is in an amount of 0.005-2% w/w, and wherein said composition has a pH between 4.0-6.5.

2. The method according to claim 1 , wherein said roflumilast skin penetration lag time is less than 60 minutes.

3. The method according to claim 2 , wherein said roflumilast skin penetration lag time is less than 45 minutes.

4. The method according to claim 1 , wherein said patient is suffering from psoriasis.

5. The method according to claim 1 , wherein said patient is suffering from atopic dermatitis.

6. A method for reducing roflumilast skin penetration lag time in a patient, comprising topically administering a composition comprising roflumilast and a) an emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, b) diethylene glycol monoethyl ether, and c) isopropyl palmitate, to a patient in need of such treatment, wherein said composition has a skin penetration lag time of less than 60 minutes, wherein said roflumilast is in an amount of 0.005-2% w/w, wherein said composition has a pH between 4.0-6.5, and wherein said composition does not include hexylene glycol.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2024
From: OSBORNE, DAVID W, DR.
To: ARCUTIS, INC.
Reel/Frame 066592/0237 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2024
From: OSBORNE, DAVID W., DR.
To: ARCUTIS, INC.
Reel/Frame 066592/0898 →
CHANGE OF NAME Recorded Dec 22, 2023
From: ARCUTIS, INC.
To: ARCUTIS BIOTHERAPEUTICS, INC.
Reel/Frame 066122/0472 →
SECURITY INTEREST Recorded Dec 22, 2021
From: ARCUTIS BIOTHERAPEUTICS, INC.
To: SLR INVESTMENT CORP., AS AGENT
Reel/Frame 058463/0187 →
Continuity (3)
Provisional Application 62742644 · Oct 8, 2018
Provisional Application 62680203 · Jun 4, 2018
Related Publication 20190365642A1 · Dec 5, 2019
Cited By (1)
US 12,310,956