	US 12,029,710 B2
	Ephedrine compositions and methods
Irfan Ali Mohammed, Piscataway, NJ (US); 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 Oct. 5, 2022, as Appl. No. 17/960,343.
Application 17/960,343 is a division of application No. 17/096,822, filed on Nov. 12, 2020, granted, now 11,491,121.
Application 17/096,822 is a continuation of application No. 16/749,378, filed on Jan. 22, 2020, granted, now 10,869,845, issued on Dec. 22, 2020.
Prior Publication US 2023/0039936 A1, Feb. 9, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/137 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01)

CPC A61K 31/137 (2013.01) [A61K 47/02 (2013.01); A61K 47/12 (2013.01)]

15 Claims

1. A method of treating hypotension in a subject in need thereof, comprising:

administering to the subject a storage-stable and sterile ephedrine composition from a pre-filled syringe;

wherein the ephedrine composition comprises about 5 mg/mL of ephedrine or a pharmaceutically acceptable salt thereof; about 9 mg/mL of sodium chloride; a pH adjuster comprising acetic acid; and water;

wherein the initial adjusted pH of the composition is in the range of about 4.6 to 4.8;

wherein the pH drift of the composition is less than 0.5 after storage for 6 months at 25° C. and 60% relative humidity; and

wherein the composition contains about 5% or less total impurities after storage for 6 months at 25° C. and 60% relative humidity as determined by HPLC.