US 12,303,482 B1
Levodopa dosing regimen
Richard D'Souza, Morristown, NJ (US); Hester Visser, Neshanic Station, NJ (US); and Suneel Gupta, Hayward, CA (US)
Assigned to Amneal Pharmaceuticals, LLC, Bridgewater, NJ (US)
Filed by Amneal Pharmaceuticals, LLC, Bridgewater, NJ (US)
Filed on Jan. 15, 2025, as Appl. No. 19/022,122.
Application 19/022,122 is a continuation of application No. 18/823,575, filed on Sep. 3, 2024.
Application 18/823,575 is a continuation of application No. 18/634,040, filed on Apr. 12, 2024, granted, now 12,109,185.
Application 18/634,040 is a continuation of application No. 17/967,332, filed on Oct. 17, 2022, granted, now 11,986,449.
Application 17/967,332 is a continuation in part of application No. 17/558,337, filed on Dec. 21, 2021, granted, now 12,194,150.
Claims priority of provisional application 63/247,639, filed on Sep. 23, 2021.
Claims priority of provisional application 63/236,403, filed on Aug. 24, 2021.
Claims priority of provisional application 63/150,121, filed on Feb. 17, 2021.
Claims priority of provisional application 63/129,063, filed on Dec. 22, 2020.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/198 (2006.01); A61K 9/50 (2006.01); A61P 25/16 (2006.01)
CPC A61K 31/198 (2013.01) [A61K 9/5005 (2013.01); A61P 25/16 (2018.01)] 29 Claims
OG exemplary drawing
 
1. A method for treating a patient diagnosed with Parkinson's disease comprising:
(i) selecting a patient diagnosed with Parkinson's disease and being treated with oral immediate release levodopa tablets for a total daily levodopa dose of 500 mg or more;
(ii) determining the amount of levodopa administered to the patient with each administration of the immediate release levodopa tablets of step (i);
(iii) determining the patient's most frequent dose of immediate release levodopa tablets from step (ii);
(iv) discontinuing the administration of the immediate release levodopa tablets; and
(v) orally administering one or more multiparticulate controlled release levodopa dosage forms thrice a day to the patient, wherein the amount of levodopa administered with each administration of the multiparticulate controlled release levodopa dosage form is 2.8 times the amount of levodopa the patient was receiving with each administration of the most frequent dose of immediate release levodopa tablets of step (iii),
wherein the patient after receiving treatment with the multiparticulate controlled release levodopa dosage form exhibits a decrease of at least 5% of the patient's total post dose “Off” time as compared to post dose of the oral immediate release levodopa tablets; and
wherein the multiparticulate controlled release dosage form comprises:
(a) a controlled release component comprising a plurality of beads that passes through a 12 mesh screen but are retained on a 24 mesh screen wherein the beads are substantially free of carbidopa, free of a catechol-O-methyl transferase inhibitor and comprise: (i) a core comprising levodopa, (ii) a controlled release coating surrounding the core, (iii) a coating comprising a muco-adhesive polymer surrounding the controlled release coating, and (iv) a coating comprising an enteric coating polymer surrounding the coating comprising the muco-adhesive polymer; and
(b) an immediate release component comprising levodopa and carbidopa.