Liquid pharmaceutical formulations of palonosetron

CAFC
  • US 8,518,981 B2
  • Filed: 04/14/2011
  • Issued: 08/27/2013
  • Est. Priority Date: 01/30/2003
  • Status: Active Grant
First Claim
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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 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.

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