Claims for Patent: 9,125,905

Summary for Patent: 9,125,905

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) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:	14/597,489
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,125,905
Patent Claims:	1. A formulation comprising a pharmaceutical sterile aqueous intravenous solution, wherein said pharmaceutical sterile aqueous intravenous solution comprises palonosetron or a pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base. 2. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of from 4 to 6. 3. The formulation of claim 1, wherein said pharmaceutical sterile aqueous intravenous solution has a pH of 5.0.+-.0.5. 4. A method of manufacturing a finished container of a pharmaceutical formulation comprising palonosetron or a pharmaceutically acceptable salt thereof, said method comprising: a) providing an open container; b) filling said container with an aqueous intravenous solution comprising said palonosetron or pharmaceutically acceptable salt thereof in an amount of 0.25 mg and a concentration of from 0.03 mg/mL to 0.2 mg/mL based on the weight of the palonosetron free base; c) sealing said filled container; and d) terminally sterilizing said sealed, filled container to obtain said finished container. 5. The method of claim 4, wherein said aqueous intravenous solution has a pH of from 4 to 6. 6. The method of claim 4, wherein said aqueous intravenous solution has a pH of 5.0.+-.0.5. 7. A finished container of palonosetron or a pharmaceutically acceptable salt thereof, manufactured and terminally sterilized by the process of claim 4. 8. The finished container of claim 7, wherein said aqueous intravenous solution has a pH of from 4 to 6. 9. The finished container of claim 7, wherein said aqueous intravenous solution has a pH of 5.0.+-.0.5.