US 12,064,521 B2
Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
Ann Hsu, Hayward, CA (US); Liang Dong, Hayward, CA (US); Amy Ding, Hayward, CA (US); and Suneel Gupta, Hayward, CA (US)
Assigned to Impax Laboratories, LLC, Bridgewater, NJ (US)
Filed by Impax Laboratories, LLC, Bridgewater, NJ (US)
Filed on Apr. 6, 2023, as Appl. No. 18/131,715.
Application 18/131,715 is a continuation of application No. 17/959,681, filed on Oct. 4, 2022, granted, now 11,666,538.
Application 17/959,681 is a continuation of application No. 17/372,434, filed on Jul. 10, 2021, granted, now 11,622,941.
Application 17/372,434 is a continuation of application No. 17/148,320, filed on Jan. 13, 2021, granted, now 11,357,733, issued on Jun. 14, 2022.
Application 17/148,320 is a continuation of application No. 16/573,634, filed on Sep. 17, 2019, granted, now 10,987,313, issued on Apr. 27, 2021.
Application 16/573,634 is a continuation in part of application No. 16/360,936, filed on Mar. 21, 2019, granted, now 10,688,058, issued on Jun. 23, 2020.
Application 16/360,936 is a continuation of application No. 15/092,086, filed on Apr. 6, 2016, granted, now 10,292,935, issued on May 21, 2019.
Application 15/092,086 is a continuation in part of application No. PCT/US2014/059554, filed on Oct. 7, 2014.
Claims priority of provisional application 61/887,762, filed on Oct. 7, 2013.
Prior Publication US 2023/0301923 A1, Sep. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/48 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/198 (2006.01); A61K 31/216 (2006.01); A61K 45/06 (2006.01)
CPC A61K 9/4808 (2013.01) [A61K 9/0053 (2013.01); A61K 9/1652 (2013.01); A61K 9/5026 (2013.01); A61K 9/5042 (2013.01); A61K 9/5073 (2013.01); A61K 31/198 (2013.01); A61K 31/216 (2013.01); A61K 45/06 (2013.01); Y02A 50/30 (2018.01)] 20 Claims
 
1. A multiparticulate controlled release oral solid formulation comprising a plurality of controlled release particles wherein the controlled release particles comprise:
a) a core comprising levodopa, esters or salts thereof,
b) a rate controlling coating surrounding the core,
c) a mucoadhesive coating surrounding the rate controlling coating, and
wherein the core is a pellet, a bead, or a granule; the formulation comprises from about 90 to 500 mg of levodopa, esters or salts thereof; and the core is free of decarboxylase inhibitor.