| 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 |
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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.
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