Liquid pharmaceutical formulations of palonosetron

1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:

palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;

from 0.005 mg/mL to 1.0 mg/mL EDTA; and

from 10 mg/mL to 80 mg/mL mannitol,

wherein said formulation is stable at 24 months when stored at room temperature.

2. The pharmaceutical formulation of claim 1 , wherein said EDTA is in an amount of 0.5 mg/mL.

3. The pharmaceutical formulation of claim 1 , wherein said mannitol is in an amount of 41.5 mg/mL.

4. The pharmaceutical formulation of claim 1 , wherein said solution further comprises a citrate buffer.

5. The pharmaceutical formulation of claim 4 , wherein said citrate buffer is at a concentration of 20 millimolar.

6. The pharmaceutical formulation of claim 1 , wherein said solution is buffered at a pH of 5.0 ±0.5.

7. The pharmaceutical formulation of claim 1 , wherein said EDTA is in an amount of 0.5 mg/mL, wherein said mannitol is in an amount of 41.5 mg/mL, wherein said solution further comprises a citrate buffer at a concentration of 20 millimolar, and wherein said solution is buffered at a pH of 5.0 ±0.5.

8. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:

palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;

from 0.005 mg/mL to 1.0 mg/mL EDTA; and

from 10 mg/mL to 80 mg/mL mannitol, wherein said formulation is stable at 18 months when stored at room temperature.