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ONCOLOGY

Physical and Chemical Stability of Palonosetron HCl in 4 Infusion Solutions

Director, Division of Pharmacy Unit 90, University of Texas MD Anderson Cancer Center, Houston, TX

Quanyun A Xu, PhD

Research Scientist, Clinical Pharmaceutics Research, University of Texas MD Anderson Cancer Center

Reprints: Lawrence A Trissel BS, Division of Pharmacy Unit 90, UTMD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030-4095, fax 713/796-1910

BACKGROUND: Palonosetron HCl is a selective 5-HT₃ receptor antagonist used for the prevention of chemotherapy-induced nausea and vomiting. Palonosetron HCl may be diluted in an infusion solution for administraton. Consequently, stability information is needed for palonosetron HCl admixed in common infusion solutions.

OBJECTIVE: To evaluate the physical and chemical stability of palonosetron HCl in concentrations of 5 and 30 µg/mL in dextrose 5% injection, NaCl 0.9% injection, dextrose 5% in NaCl 0.45% injection, and dextrose 5% in lactated Ringer's injection.

METHODS: Triplicate test samples of palonosetron HCl at each concentration in each diluent were tested. Samples were stored and evaluated at appropriate intervals for up to 48 hours at room temperature (23 °C) and 14 days under refrigeration (4 °C). Physical stability was assessed using turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed by HPLC.

RESULTS: All of the admixtures were initially clear and colorless when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study. The drug concentration was unchanged in any of the samples at either temperature throughout the study.

CONCLUSIONS: Palonosetron HCl is physically and chemically stable in all 4 common infusion solutions for at least 48 hours at room temperature and 14 days under refrigeration.

Key Words: compatibility, palonosetron, stability

Published Online, August 24, 2004. www.theannals.com, DOI 10.1345/aph.1D509

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