US 12,257,342 B2
Phenylephrine hydrochloride ready-to-use solution
David E. McAnany, Berkeley Heights, NJ (US); Michael G. Parker, Berkeley Heights, NJ (US); and Sarah D. Mccue, Berkeley Heights, NJ (US)
Assigned to Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ (US)
Filed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ (US)
Filed on Sep. 9, 2022, as Appl. No. 17/941,640.
Application 17/941,640 is a continuation of application No. 17/495,548, filed on Oct. 6, 2021, granted, now 11,471,400.
Application 17/495,548 is a continuation of application No. 15/230,352, filed on Aug. 5, 2016, granted, now 11,213,480, issued on Jan. 4, 2022.
Claims priority of provisional application 62/202,146, filed on Aug. 6, 2015.
Prior Publication US 2023/0014425 A1, Jan. 19, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61J 1/06 (2006.01); A61K 9/08 (2006.01); A61K 31/137 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); B65B 3/00 (2006.01); B65B 7/16 (2006.01); B65B 55/06 (2006.01)
CPC A61K 9/0019 (2013.01) [A61J 1/06 (2013.01); A61K 9/08 (2013.01); A61K 31/137 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); B65B 3/003 (2013.01); B65B 7/16 (2013.01); B65B 55/06 (2013.01)] 21 Claims
 
1. A stable, ready-to-use sterile intravenous injection solution of phenylephrine hydrochloride packaged into a vial for injection, wherein the solution comprising:
from about 0.05 mg/mL to about 0.15 mg/mL phenylephrine hydrochloride as the only active pharmaceutical ingredient in the solution;
from about 0.1 mg/mL to about 0.3 mg/mL of edetate disodium (EDTA);
sodium chloride; and
water;
wherein the solution has a pH between 3 and 6.5, is stored in a single use vial, and exhibits 0.2% or less of phenylephrine impurities after exposure to a temperature of 40° C. for a period of 6 months; and wherein the solution is free of bisulfites or other antioxidants.