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 cancer chemotherapy induced nausea and vomiting or reducing the likelihood of cancer chemotherapy induced nausea and vomiting 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 an amount of 0.25 mg and a concentration of 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base.
2. The formulation of claim 1 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
3. The formulation of claim 1 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution is isotonic.
4. The formulation of claim 3 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
5. The formulation of claim 1 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises palonosetron or a pharmaceutically acceptable salt thereof in a concentration of 0.05 mg/mL based on the weight of the palonosetron free base.
6. The formulation of claim 5 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
7. The formulation of claim 5 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution has a pH of from 4.0 to 6.0.
8. The formulation of claim 7 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
9. The formulation of claim 7 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises a tonicifying agent.
10. The formulation of claim 9 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
11. The formulation of claim 9 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises a chelating agent.
12. The formulation of claim 11 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
13. The formulation of claim 11 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises from 0.3 mg/mL to 0.7 mg/mL EDTA.
14. The formulation of claim 13 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
15. The formulation of claim 9 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises from 40.0 mg/mL to 45.0 mg/mL mannitol.
16. The formulation of claim 15 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
17. The formulation of claim 15 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises from 0.3 mg/mL to 0.7 mg/mL EDTA.
18. The formulation of claim 17 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.
19. The formulation of claim 17 , wherein said pharmaceutical single-use, unit-dose, sterile aqueous intravenous solution comprises 41.5 mg/mL mannitol and 0.5 mg/mL EDTA.
20. The formulation of claim 19 for reducing delayed cancer chemotherapy induced nausea and vomiting or reducing the likelihood of delayed cancer chemotherapy induced nausea and vomiting in a human.