Patent ID: 8518981

Claim:
A method of manufacturing and terminally sterilizing a finished single unit dose vial of palonosetron or a pharmaceutically acceptable salt thereof comprising: a) providing one or more sterile open containers; b) filling said containers with a pharmaceutically stable solution of palonosetron or a pharmaceutically acceptable salt thereof; c) sealing said filled containers; d) terminally sterilizing said sealed, filled containers; and e) optionally adjusting the pH of said solution using HCl or NaOH prior to step (c), wherein the pharmaceutically stable solution has a pH of from about 4.0 to about 6.0 and comprises palonosetron hydrochloride in a concentration of from about 0.03 mg/mL to about 0.2 mg/mL based on the weight of the free base, an aqueous carrier, and a tonicity agent, and wherein the pharmaceutically stable solution optionally comprises one or a combination of mannitol, a chelating agent, and a citrate buffer.