US 12,295,931 B2
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 Sep. 3, 2024, as Appl. No. 18/823,575.
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.
Prior Publication US 2025/0000831 A1, Jan. 2, 2025
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)] 25 Claims
OG exemplary drawing
 
1. A dosing regimen comprising orally administering a controlled release levodopa dosage form twice, thrice, or four times a day to a Parkinson's disease patient,
wherein the patient prior to receiving the controlled release levodopa dosage form was being treated with oral immediate release levodopa tablets,
wherein the administration of the oral immediate release levodopa tablets was discontinued and replaced with the dosing regimen of controlled release levodopa dosage forms,
wherein the amount of levodopa administered with each administration of the discontinued immediate release levodopa tablets was determined, and the amount of levodopa administered with each administration of the controlled release levodopa dosage form is 2.8 times the amount of levodopa the patient was receiving with each administration of the discontinued immediate release levodopa tablets prior to the administration of the controlled release dosage form,
wherein the patient after receiving the treatment with the controlled release dosage form exhibits a decrease of at least 5% of the patient's post-dose “Off”′ time as compared to patient's post-dose “Off”′ time during the treatment with the oral immediate release levodopa tablets,
wherein the controlled release dosage form comprises one or more immediate release components comprising levodopa and a decarboxylase inhibitor, and a plurality of controlled release components comprising a core comprising levodopa, a controlled release material, and a coating comprising an enteric polymer surrounding the levodopa and controlled release material wherein the controlled release components pass through a 12 mesh screen and the plurality of controlled release components are substantially free of carbidopa; and
wherein the controlled release dosage form when tested using a USP Type I apparatus at 37° C.±0.5° C. with a rotational speed of 75 rpm and about 900 ml of simulated gastric fluid for 2 hours and pH 6.8 phosphate buffer thereafter, about 75% to about 100% of the decarboxylase inhibitor is released within 30 minutes; and about 15% to about 45% of levodopa is released within 30 minutes; and the simulated gastric fluid has a pH of from about 1 to about 4.0.