Claims for Patent: 11,844,783

Summary for Patent: 11,844,783

Title:	Formulations of bendamustine
Abstract:	Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
Inventor(s):	Nagesh R. Palepu, Philip Christopher Buxton
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US18/081,238
Patent Claims:	1. A method of treating leukemia in a human in need thereof comprising providing a liquid bendamustine-containing composition comprising bendamustine, or a pharmaceutically acceptable salt thereof, wherein the bendamustine concentration in the composition is from about 20 mg/mL to about 60 mg/mL, a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and a stabilizing amount of an antioxidant wherein the total impurities in the liquid bendamustine-containing composition resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. to about 25° C.; diluting the liquid bendamustine containing composition; and intravenously administering the diluted composition to the human. 2. The method of claim 1, wherein the liquid bendamustine containing composition is diluted with about 50 mL of a diluent. 3. The method of claim 1, wherein the concentration of bendamustine in the liquid bendamustine-containing compositions is about 25 mg/ml. 4. The method of claim 1, wherein the concentration of bendamustine in the liquid bendamustine-containing composition is 25 mg/ml. 5. The method of claim 1, wherein the liquid bendamustine-containing composition includes 100 mg of bendamustine at a concentration of 25 mg/mL. 6. The method of claims 1, wherein the antioxidant is monothioglycerol. 7. The method of claim 1, wherein the antioxidant in the liquid bendamustine containing composition is monothioglycerol in a concentration of about 5 mg/mL. 8. The method of claim 1, wherein the liquid bendamustine-containing composition is stable for at least about 15 months at 5° C. or for at least about 15 months at 25° C., prior to dilution. 9. The method of claim 1, wherein the liquid bendamustine-containing composition further comprises ethanol. 10. The method of claims 1, wherein the liquid bendamustine-containing composition is packages in a sterile vial. 11. A method of treating leukemia in a human in need thereof comprising providing a liquid bendamustine-containing composition packaged in a sterile vial and comprising 100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, at a concentration of about 25 mg/mL; a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and a stabilizing amount of an antioxidant that is monothioglycerol; wherein the total impurities in the liquid bendamustine-containing composition resulting from the degradation of the bendamustine is less than about 5% peak area response, as determined by HPLC at a wavelength of 223 nm after at least about 15 months at a temperature of about 5° C. or for at least about 15 months at 25° C.; diluting the liquid bendamustine containing composition with about 50 mL of a diluent; and intravenously administering the diluted composition to the human. 12. The method of claim 11, wherein the liquid bendamustine-containing composition comprises100 mg of bendamustine, or a pharmaceutically acceptable salt thereof, at a concentration of 25 mg/mL. 13. The method of claim 12, wherein the liquid bendamustine-containing composition further comprises ethanol. 14. The method of claim 12, wherein the liquid bendamustine containing composition is diluted with about 50 mL of a diluent.