Compatibility and Stability of Palonosetron Hydrochloride with Lactated Ringer's Hetastarch in Lactated Electrolyte, and Mannitol Injections During Simulated Y-Site Administration.

Palonosetron hydrochloride is a longer-acting, selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting ad is being evaluated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50mcg/mL when mixed with Lactated Ringer's injection, 6% hetastarch in lactated electrolyte injection, or 15% mannitol injection during simulated Y-site administration. Duplicate samples of each admixture were tested. The samples were stored and evaluated for 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements, and by visual inspection. Chemical stability was assessed by using high-performance liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the observation period. Palonosetron hydrochloride concentration was unchanged in any of the samples throughout the study period. Palonosetron hydrochlorie is physically and chemically stable with Lactated Ringer's injection, 6% hetastarch in lactated elecrolyte injection, or 15% mannitol injection during simulated Y-site administration over 4 hours at ambient room temperature.