US 12,290,494 B2
Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
Steven M. Cope, Lake Villa, IL (US); and Allan E. Titus, Deerfield, IL (US)
Assigned to Baxter International Inc., Deerfield, IL (US); and Baxter Healthcare SA, Glattpark (CH)
Filed by Baxter International Inc., Deerfield, IL (US); and Baxter Healthcare SA, Glattpark (CH)
Filed on Nov. 26, 2024, as Appl. No. 18/961,126.
Application 18/961,126 is a continuation of application No. 18/635,810, filed on Apr. 15, 2024.
Application 18/635,810 is a continuation of application No. 17/249,642, filed on Mar. 8, 2021, granted, now 12,097,170, issued on Sep. 24, 2024.
Claims priority of provisional application 62/986,606, filed on Mar. 6, 2020.
Prior Publication US 2025/0090483 A1, Mar. 20, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61J 1/10 (2006.01); A61J 1/14 (2023.01); A61M 5/00 (2006.01); A61M 5/14 (2006.01); B65D 75/28 (2006.01); B65D 81/26 (2006.01); A61M 1/14 (2006.01)
CPC A61K 31/137 (2013.01) [A61J 1/10 (2013.01); A61J 1/1468 (2015.05); A61M 5/002 (2013.01); B65D 75/28 (2013.01); B65D 81/266 (2013.01); A61J 1/14 (2013.01); A61J 1/1475 (2013.01); A61M 1/14 (2013.01); A61M 5/14 (2013.01)] 21 Claims
OG exemplary drawing
 
1. A packaged, sealed container system for stable storage of a ready-to-use, stable norepinephrine formulation, the packaged, sealed container system comprising:
a primary container comprising a ready-to-use, stable norepinephrine formulation therein, the ready-to-use, stable norepinephrine formulation comprising:
about 0.015 mg/ml to about 0.035 mg/ml norepinephrine; dextrose; and
a pH between 3.4 and 4.0;
wherein the ready-to-use, stable norepinephrine formulation is free of an antioxidant;
a secondary container comprising a first flexible sheet, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, wherein the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary container; and
an oxygen scavenger disposed between and enclosed by the first and second flexible sheet layers of the secondary container, the oxygen scavenger being in fluid communication with the contents of the primary container,
wherein the primary container is an intravenous (IV) bag; and
wherein the ready-to-use, stable norepinephrine formulation does not comprise sodium chloride,
wherein the norepinephrine is in the form of norepinephrine bitartrate monohydrate,
wherein the ready-to-use, stable norepinephrine formulation has a dissolved oxygen level of less than 0.5 ppm after storage for at least 150 days at 25° C., and
wherein the ready-to-use, stable norepinephrine formulation retains at least about 90% of an initial activity as measured by an initial and a final amount of R-norepinephrine present in the formulation after storage for at least 120 days at 25° C.