	US 12,109,211 B2
	Hydralazine compositions and methods
Kumaresh Soppimath, Skillman, NJ (US); Tushar Hingorani, Bridgewater, NJ (US); Hari A. Attluri, Jersey City, NJ (US); and Harshil H. Jain, Monmouth Junction, NJ (US)
Assigned to ENDO OPERATIONS LIMITED, Ballsbridge (IE)
Filed by Endo Ventures Limited, Dublin (IE)
Filed on Dec. 27, 2022, as Appl. No. 18/146,756.
Claims priority of provisional application 63/294,670, filed on Dec. 29, 2021.
Prior Publication US 2023/0201197 A1, Jun. 29, 2023
Int. Cl. A61K 31/502 (2006.01); A61K 9/08 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01)

CPC A61K 31/502 (2013.01) [A61K 9/08 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01)]

18 Claims

1. A sterile, ready-to-use pharmaceutical composition comprising:

hydralazine and/or a salt thereof at a concentration of about 10 mg/mL, and

a solvent comprising a co-solvent, wherein the solvent comprises water and the co-solvent comprises propylene glycol,

wherein the co-solvent and the hydralazine and/or salt thereof are provided at a weight ratio of no more than about 7.5:1, and wherein the hydralazine and/or salt thereof has a change in concentration of no more than about 10% after 2 months of storage at 60° C.