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Last Updated: April 5, 2025

Claims for Patent: 9,439,854

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Summary for Patent: 9,439,854

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:	14/793,233
Patent Claims:	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.

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