US 12,303,481 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 Aug. 13, 2024, as Appl. No. 18/802,151.
Application 18/802,151 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 2024/0398743 A1, Dec. 5, 2024
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)] 21 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 less than 500 mg;
(ii) determining the amount of levodopa administered to the patient with each administration of the immediate release levodopa tablets of step (i);
selecting the most frequent dose of the patient's dosing regimen of the immediate release tablets from step (ii);
(iv) discontinuing the administration of the immediate release levodopa tablets; and
(v) orally administering a controlled release levodopa dosage form twice or thrice a day to the patient, wherein 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 most frequent dose of the immediate release levodopa tablets of step (iii),
wherein the patient after receiving treatment with the controlled release dosage form exhibits an increase of at least 5% of the patient's total post-dose “On” time or “Good On” time compared to post-dose of the oral immediate release levodopa tablets, wherein the controlled release dosage form comprises:
(a) a plurality of controlled release components comprising a core comprising levodopa and a controlled release material, and a coating comprising an enteric polymer surrounding the levodopa and controlled release material; and
(b) one or more immediate release components comprising levodopa and carbidopa; wherein the 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 carbidopa is released within 30 minutes; and about 15% to about 45% of levodopa is released within 30 minutes; wherein the simulated gastric fluid has a pH of from about 1 to about 4.0.