Injectable Nitrogen Mustard Compositions Comprising a Cyclodextrin Derivative and Methods of Making and Using the Same
AssigneeCyDex Pharmaceuticals, Inc.
InventorsJames D. Pipkin, Stephen G. Machatha
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Abstract
The present disclosure is directed to pharmaceutical compositions comprising a nitrogen mustard and a cyclodextrin derivative, and methods of making and using the same.
Claims6
An injectable aqueous pharmaceutical formulation comprising 8.5 mL of an aqueous solution at a pH of 5, said solution comprising 9 g/L sodium chloride, said formulation further comprising a sulfobutyl ether-β-cyclodextrin and melphalan, wherein said sulfobutyl ether-β-cyclodextrin and said melphalan are present in a weight ratio of 54:1;
- wherein said melphalan is present at a concentration of 5 mg/mL;
- and
- wherein said aqueous pharmaceutical formulation is stable, at room temperature for at least one hour, as compared to a reference melphalan standard.
An injectable aqueous pharmaceutical formulation comprising 10 mL of an aqueous solution with a pH of 5, said formulation comprising a sulfobutyl ether-β-cyclodextrin and melphalan;
- wherein said sulfobutyl ether-β-cyclodextrin and said melphalan are present in a weight ratio of at least 54:1;
- wherein said melphalan is present in said aqueous pharmaceutical formulation at a concentration of 0.45 mg/mL;
- and
- wherein said aqueous pharmaceutical formulation is stable, at room temperature for at least 4 hours, as compared to a reference melphalan standard.
Dependencies are inferred from the claim text.