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Abstract:  The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron hydrochloride 50 µg/mL in combination with lorazepam 0.5 mg/mL or midazolam hydrochloride 2 mg/mL in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 5 mL of palonosetron hydrochloride with 5 mL of the lorazepam or midazolam hydrochloride admixture. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurements as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques that determined drug concentrations. Evaluations were performed initially upon mixing and again 1 and 4 hours after mixing. The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity remained unchanged; particulate content was low and changed little. High-performance liquid chromatographic analysis revealed that palonosetron hydrochloride, lorazepam, and midazolam hydrochloride remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is physically compatible and chemically stable with lorazepam or midazolam hydrochloride during Y-site administration.

Related Keywords: Lawrence A. Trissel, BS, RPh, FASHP, Quanyan A. Xu, PhD, palonosetron hydrochloride, 5-HT3 receptor antagonist, lorazepam, midazolam, antiemetic, emesis, nausea, vomiting, benzodiazepine, cancer chemotherapy, stability

Related Categories: CANCER AND AIDS, GASTROENTEROLOGY, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, NEUROLOGY

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