Palonosetron HCI compatibility and stability with doxorubicin HCI and epirubicin HCI during simulated Y-site administration

BACKGROUND: Palonosetron HCI is a selective 5-HT3 receptor antagonist used for the prevention of chemotherapy-induced nausea and vomiting. Palonosetron HCI may be administered with other drugs by Y-site administration, including doxorubicin HCI and epirubicin HCI. Consequently, stability and compatability information are needed to verify the acceptability of such Y-site administration. OBJECTIVE: To evaluate the physical and chemical stability of undiluted palonosetron HCI 50 mug/mL with doxorubicin HCI 1 mg/mL and epirubicin HCI 0.5 mg/mL during simulated Y-site administration. METHODS: Triplicate samples of palonosetron HCI with each of the anthracycline chemotherapy drugs were tested. Samples were stored and evaluated for up to 4 hours at room temperature near 23degreesC. 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 clear and red-orange 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 throughout the study. CONCLUSIONS: Palonosetron HCI is physically and chemically stable with doxorubicin HCI and epirubicin HCI during simulated Y-site administration of these drugs over 4 hours at ambient room temperature.