Claims for Patent: 9,457,021

Summary for Patent: 9,457,021

Title:	Liquid pharmaceutical formulations of palonosetron
Abstract:	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.
Inventor(s):	Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, IT), Cannella; Roberta (Varese, IT), Macciocchi; Alberto (Melide, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA)
Assignee:	Helsinn Healthcare SA (Lugano/Pazzallo, CH)
Application Number:	15/190,019
Patent Claims:	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.