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|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.degree. C. to about 25.degree. C.|
|Inventor(s):||Palepu; Nagesh R. (Southampton, PA), Buxton; Philip Christopher (Great Dunmow, GB)|
|Assignee:||Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)|
1. A non-aqueous liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof; and b) a pharmaceutically acceptable fluid
comprising; i) about 5% to about 10% by volume propylene glycol, ii) polyethylene glycol, and iii) a stabilizing amount of an antioxidant selected from the group consisting of thioglycerol, monothioglycerol, lipoic acid, propyl gallate, methionine,
cysteine, metabisulfites, sodium formaldehyde sulfoxylate, phenol-containing aromatic and aliphatic compounds and dihydrolipoic acid; the bendamustine-containing composition having less than or equal to 0.11% total PG esters at about 1 month of storage
at a temperature of about 5.degree. C.; wherein the ratio of polyethylene glycol to propylene glycol is selected from the group consisting of: about 95:5, about 90:10, about 85:15, about 80:20 and about 75:25.
2. The liquid bendamustine-containing composition of claim 1, wherein said bendamustine-containing composition has less than or equal to 0.18% total PG esters at about 12 months of storage at a temperature of about 5.degree. C.
3. The liquid bendamustine-containing composition of claim 1, wherein the amount of propylene glycol in the pharmaceutically acceptable fluid is about 10%.
4. The liquid bendamustine-containing composition of claim 1, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL.
5. The liquid bendamustine-containing composition of claim 4, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL.
6. The liquid bendamustine-containing composition of claim 5, wherein the bendamustine concentration is about 50 mg/mL.