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Last Updated: January 26, 2021

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Claims for Patent: 10,010,533

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Summary for Patent: 10,010,533
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:15/432,335
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,010,533
Patent Claims: 1. A liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof; and b) a pharmaceutically acceptable fluid comprising about 5% to about 10% propylene glycol, polyethylene glycol and 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.

7. A liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof; and b) a pharmaceutically acceptable fluid comprising propylene glycol, polyethylene glycol and 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 0.12% total PG esters at about 15 days of storage at a temperature of about 25.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.

8. The liquid bendamustine-containing composition of claim 7, wherein said bendamustine-containing composition has less than or equal to 0.25% total PG esters at about 1 month of storage at a temperature of about 25.degree. C.

9. The liquid bendamustine-containing composition of claim 7, wherein said bendamustine-containing composition has less than or equal to 0.43% total PG esters at about 3 months of storage at a temperature of about 25.degree. C.

10. The liquid bendamustine-containing composition of claim 7, wherein said bendamustine-containing composition has less than or equal to 0.77% total PG esters at about 6 months of storage at a temperature of about 25.degree. C.

11. The liquid bendamustine-containing composition of claim 7, wherein the bendamustine-containing composition has less than or equal to 0.25% total PG esters at about 1 month of storage at a temperature of about 25.degree. C., has less than or equal to 0.43% total PG esters at about 3 months of storage at a temperature of about 25.degree. C., and has less than or equal to 0.77% total PG esters at about 6 months of storage at a temperature of about 25.degree. C.

12. The liquid bendamustine-containing composition of claim 7, wherein the amount of propylene glycol in the pharmaceutically acceptable fluid is about 10%.

13. The liquid bendamustine-containing composition of claim 7, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL.

14. The liquid bendamustine-containing composition of claim 7, wherein the bendamustine concentration is from about 25 mg/mL to about 50 mg/mL.

15. The liquid bendamustine-containing composition of claim 14, wherein the bendamustine concentration is about 50 mg/mL.

16. A liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof; and b) a pharmaceutically acceptable fluid comprising about 5% to about 10% propylene glycol, polyethylene glycol and 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; 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.

17. The liquid bendamustine-containing composition of claim 16, wherein said bendamustine-containing composition has less than or equal to 0.11% total PG esters at about 1 month of storage at a temperature of about 5.degree. C.

18. The liquid bendamustine-containing composition of claim 16, 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.

19. The liquid bendamustine-containing composition of claim 16, wherein said bendamustine-containing composition has less than or equal to 0.12% total PG esters at about 15 days of storage at a temperature of about 25.degree. C.

20. The liquid bendamustine-containing composition of claim 16, wherein said bendamustine-containing composition has less than or equal to 0.25% total PG esters at about 1 month of storage at a temperature of about 25.degree. C.

21. The liquid bendamustine-containing composition of claim 16, wherein said bendamustine-containing composition has less than or equal to 0.43% total PG esters at about 3 months of storage at a temperature of about 25.degree. C.

22. The liquid bendamustine-containing composition of claim 16, wherein said bendamustine-containing composition has less than or equal to 0.77% total PG esters at about 6 months of storage at a temperature of about 25.degree. C.

23. The liquid bendamustine-containing composition of claim 16, wherein the bendamustine concentration is from about 20 mg/mL to about 60 mg/mL.

24. The liquid bendamustine-containing composition of claim 23, wherein the bendamustine concentration is about 50 mg/mL.

25. The liquid bendamustine-containing composition of claim 16, wherein the antioxidant is thioglycerol or monothioglycerol.

26. The liquid bendamustine-containing composition of claim 16, wherein the antioxidant concentration is from about 2.5 mg/mL to about 35 mg/mL.

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