Patent ID: 8598218
Filing Date: 2013-12-03
Classification: A61J,A61K,A61P,B65B

Abstract:
1. 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 about 5 ml of an aqueous 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 said solution to a pH of from about 4.0 to about 6.0 prior to step (c), wherein the pharmaceutically stable solution comprises palonosetron hydrochloride in an amount of about 0.25 mg based on the weight of its 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.