US 12,245,996 B2
Norepinephrine compositions and methods therefor
Tushar Hingorani, Bridgewater, NJ (US); and Kumaresh Soppimath, Skillman, NJ (US)
Assigned to NEVAKAR INJECTABLES INC., Bridgewater, NJ (US)
Filed by Nevakar Injectables Inc., Bridgewater, NJ (US)
Filed on Jul. 11, 2022, as Appl. No. 17/861,752.
Application 17/861,752 is a division of application No. 16/839,450, filed on Apr. 3, 2020, granted, now 11,413,259.
Application 16/839,450 is a division of application No. 16/239,465, filed on Jan. 3, 2019, granted, now 10,646,458, issued on May 12, 2020.
Application 16/239,465 is a division of application No. 15/883,798, filed on Jan. 30, 2018, granted, now 10,226,436, issued on Mar. 12, 2019.
Claims priority of provisional application 62/452,220, filed on Jan. 30, 2017.
Prior Publication US 2022/0409558 A1, Dec. 29, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61P 9/02 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/0019 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61P 9/02 (2018.01)] 19 Claims
 
1. A sterile storage stable ready-to-inject norepinephrine composition, comprising:
an aqueous pharmaceutically acceptable solution containing norepinephrine, a tonicity agent, and a metal ion chelator;
wherein the composition contains the norepinephrine in an amount of equal or less than 100 μg/ml;
wherein the norepinephrine is present as an R-isomer in an amount of at least at least 90% of total norepinephrine;
wherein the aqueous solution comprises the metal ion chelator in an amount of between 1 μg/ml and 100 μg/ml, and wherein the metal ion chelator is a bicarboxylic acid;
wherein the tonicity agent is selected from the group consisting of a pharmaceutically acceptable salt, glycerol, a sugar alcohol, and a sugar; and
wherein the pH of the aqueous solution is in a range of between 3.7-5.0, and wherein the composition is substantially antioxidant-free.