US 12,220,409 B2
Roflumilast formulations with an improved pharmacokinetic profile
David Osborne, Fort Collins, CO (US)
Assigned to ARCUTIS BIOTHERAPEUTICS, INC., Westlake Village, CA (US)
Filed by Arcutis Biotherapeutics, Inc., Westlake Village, CA (US)
Filed on Jun. 17, 2024, as Appl. No. 18/744,999.
Application 15/676,356 is a division of application No. 15/616,409, filed on Jun. 7, 2017, granted, now 9,895,359, issued on Feb. 20, 2018.
Application 18/744,999 is a continuation of application No. 18/597,574, filed on Mar. 6, 2024, granted, now 12,011,437.
Application 18/597,574 is a continuation of application No. 18/453,674, filed on Aug. 22, 2023, granted, now 12,016,848.
Application 18/597,574 is a continuation of application No. 18/353,870, filed on Jul. 17, 2023, granted, now 12,042,487.
Application 18/453,674 is a continuation of application No. 17/327,236, filed on May 21, 2021, granted, now 11,992,480, issued on May 8, 2024.
Application 18/453,674 is a continuation of application No. 17/155,679, filed on Feb. 5, 2021.
Application 17/155,679 is a continuation in part of application No. 17/102,056, filed on Nov. 23, 2020, granted, now 11,793,796, issued on Oct. 24, 2023.
Application 17/327,236 is a continuation of application No. 16/563,435, filed on Sep. 6, 2019.
Application 17/102,056 is a continuation of application No. 16/136,804, filed on Sep. 20, 2018, granted, now 10,940,142, issued on Mar. 9, 2021.
Application 16/136,804 is a continuation of application No. 15/848,505, filed on Dec. 20, 2017, granted, now 10,105,354, issued on Oct. 23, 2018.
Application 15/848,505 is a continuation of application No. 15/676,356, filed on Aug. 14, 2017, granted, now 9,884,050.
Claims priority of provisional application 62/768,314, filed on Nov. 16, 2018.
Prior Publication US 2024/0335435 A1, Oct. 10, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/44 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 9/14 (2006.01); A61K 45/06 (2006.01); A61K 47/10 (2017.01); C09K 15/06 (2006.01)
CPC A61K 31/44 (2013.01) [A61K 9/0014 (2013.01); A61K 9/06 (2013.01); A61K 9/145 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01); C09K 15/06 (2013.01)] 30 Claims
 
1. A topical roflumilast pharmaceutical composition comprising:
(i) roflumilast in an amount of 0.05-1.0% (w/w);
(ii) water;
(iii) a solvent comprising diethylene glycol monoethyl ether; and
(iv) a surfactant;
wherein said topical roflumilast composition has a roflumilast absorption profile that produces in a patient following administration a plasma concentration time curve with a peak to trough ratio less than 2 at steady state.