US 12,133,837 B2
Epinephrine compositions and containers
Prem Sagar Akasapu, Edison, NJ (US); Kumaresh Soppimath, Skillman, NJ (US); Reema Ajitkumar Puri, Hillsborough, NJ (US); Iouri V. Ilitchev, Hillsborough, NJ (US); Milan Patel, Edison, NJ (US); and Pooja H. Tendulkar, East Brunswick, NJ (US)
Assigned to NEVAKAR INJECTABLES INC., Bridgewater, NJ (US)
Filed by Nevakar Injectables Inc., Bridgewater, NJ (US)
Filed on Nov. 15, 2021, as Appl. No. 17/526,786.
Application 17/526,786 is a continuation of application No. 16/821,785, filed on Mar. 17, 2020, granted, now 11,207,280.
Application 16/821,785 is a continuation of application No. 16/788,831, filed on Feb. 12, 2020, granted, now 11,071,719, issued on Jul. 27, 2021.
Application 16/788,831 is a continuation of application No. 16/360,995, filed on Mar. 21, 2019, granted, now 10,653,646, issued on May 19, 2020.
Claims priority of provisional application 62/647,303, filed on Mar. 23, 2018.
Prior Publication US 2022/0110891 A1, Apr. 14, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/137 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/183 (2013.01)] 17 Claims
 
1. A sterile storage stable ready-to-inject epinephrine composition, comprising:
an aqueous pharmaceutically acceptable carrier containing epinephrine, a tonicity agent, and a metal ion chelator;
wherein the epinephrine is present at a concentration of equal or less than 0.07 mg/ml, and wherein at least about 90 mol % of the epinephrine is an R-isomer;
wherein the composition has a pH of between 3.0-4.7;
wherein the metal ion chelator is a bicarboxylic acid, a tricarboxylic acid, or an aminopolycarboxylic acid;
wherein the metal ion chelator is present in the composition at a concentration of between about 1 and 50 μg/ml; and
wherein the composition has a total impurities concentration of equal to or less than 0.3% after storage of at least one month at 25° C.