Liquid pharmaceutical formulations of palonosetron
The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
1. A formulation for reducing emesis or reducing the likelihood of emesis in a human, the formulation comprising a pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprising palonosetron or a pharmaceutically acceptable salt thereof in a concentration of 0.05 mg/mL based on the weight of the palonosetron free base and in a volume of from 1 mL to 5 mL.
2. The formulation of claim 1 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution has a pH of from 4.0 to 6.0.
3. The formulation of claim 2 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises a tonicifying agent.
4. The formulation of claim 3 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises a chelating agent.
5. The formulation of claim 3 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises from 40.0 mg/mL to 45.0 mg/mL mannitol.
6. The formulation of claim 4 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises from 0.3 mg/mL to 0.7 mg/mL EDTA.
7. The formulation of claim 5 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution further comprises from 0.3 mg/mL to 0.7 mg/mL EDTA.
8. The formulation of claim 7 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises 41.5 mg/mL mannitol and 0.5 mg/mL EDTA.