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Claims for Patent: 8,609,707

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Claims for Patent: 8,609,707

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)
Application Number:13/016,473
Patent Claims: 1. A tong term storage stable non-aqueous liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof, and b) a pharmaceutically acceptable fluid comprising i) about 90% polyethylene glycol and about 10% propylene glycol; and ii) a stabilizing amount of an antioxidant.

2. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 1, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL.

3. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 2, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL.

4. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 3, wherein the bendamustine concentration is from about 30 mg/mL to about 50 mg/mL.

5. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 4, wherein the bendamustine concentration is about 50 mg/mL.

6. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 1, wherein the antioxidant is 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.

7. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 6, wherein the antioxidant is thioglycerol or monothioglycerol.

8. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 6, wherein the antioxidant is lipoic acid.

9. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 1, wherein the stabilizing amount of the antioxidant is from about 2.5 mg/mL to about 35 mg/mL.

10. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 9, wherein the stabilizing amount of the antioxidant is from about 5 mg/mL to about 20 mg/mL.

11. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 10, wherein the stabilizing amount of the antioxidant is from about 10 mg/mL to about 15 mg/mL.

12. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 10, wherein the stabilizing amount of the antioxidant is about 5 mg/mL.

13. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 1, wherein said long term storage is at least 2 years.

14. A tong term storage stable non-aqueous liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof, and b) a pharmaceutically acceptable fluid comprising i) about 90% polyethylene glycol and about 10% propylene glycol; and ii) a stabilizing amount of thioglycerol.

15. A tong term storage stable non-aqueous liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof, and b) a pharmaceutically acceptable fluid comprising i) about 90% polyethylene glycol and about 10% propylene glycol; and ii) a stabilizing amount of 2.5 mg/mL thioglycerol.

16. A method of treating cancer in mammals, comprising administering an effective amount of a long term storage stable non-aqueous liquid bendamustine-containing composition of claim 1 to a mammal in need thereof.

17. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 14, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL.

18. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 17, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL.

19. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 18, wherein the bendamustine concentration is about 50 mg/mL.

20. The long term storage stable non-aqueous liquid bendamustine-containing composition of claim 14, wherein said long term storage is at least 2 years.

21. The method of treating cancer in mammals of claim 16, wherein the cancer is leukemia.

22. The method of treating cancer in mammals of claim 16, wherein the cancer is Hodgkin's disease.
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