US 12,390,457 B2
Stable solutions of immunomodulatory imide compounds for parenteral use
Rod L. Hartwig, Sloatsburg, NY (US); Arturo Serrano-Batista, Sloatsburg, NY (US); and James Oliver, Raleigh, NC (US)
Assigned to Starton Therapeutics, Inc., Paramus, NJ (US)
Filed by Starton Therapeutics, Inc., Paramus, NJ (US)
Filed on Jan. 7, 2022, as Appl. No. 17/570,463.
Claims priority of provisional application 63/135,347, filed on Jan. 8, 2021.
Prior Publication US 2022/0218687 A1, Jul. 14, 2022
Int. Cl. A61K 31/454 (2006.01); A61K 31/5377 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); A61K 47/32 (2006.01)
CPC A61K 31/454 (2013.01) [A61K 31/5377 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/32 (2013.01)] 6 Claims
 
1. A stable liquid formulation of lenalidomide for parenteral administration, comprising lenalidomide, n-methyl-2-pyrrolidone, polyvinylpyrrolidone K12, a buffering agent comprising citric acid and sodium bicarbonate, and water, wherein the lenalidomide is present in solubilized form at a concentration ranging from about 0.01 wt. % to about 0.8 wt. % based on the total weight of the liquid formulation, the n-methyl-2-pyrrolidone is present at a concentration ranging from about 1 wt. % to about 20 wt. % based on the total weight of the liquid formulation, the polyvinylpyrrolidone K12 is present at a concentration ranging from about 1 wt. % to about 10 wt. % based on the total weight of the liquid formulation, the citric acid is present at a concentration ranging from about 0.01 wt. % to about 2 wt. % based on the total weight of the liquid formulation, the sodium bicarbonate is present at a concentration ranging from about 0.01 wt. % to about 2 wt. % based on the total weight of the liquid formulation, and the water is at a concentration ranging from about 55 wt. % to about 99.8 wt. % based on the total weight of the liquid formulation, wherein the liquid formulation has an osmolality ranging from about 300 mOsm/kg to about 600 mOsm/kg when the lenalidomide is present at a concentration of about 0.05 wt. % based on the total weight of the liquid formulation, and the liquid formulation has a pH between about 4.5 and about 5.5.