Palonosetron hydrochloride compatiblity and stability with three B-lactam anitbiotic during simulated y-site adminstration.

ABSTRACT

Palonosetron hydrochloride is a relatively long-acting selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting and is being ealuated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50 mcg/mL with the B-lactam antibiotics cefazolin sodium 20 mg/mL, cefotetan disodium 20 mg/mL, and the combination ampicillin sodium-sulbactam sodium 20 mg/mL and 10 mg/mL, respectively, during simulated Y-site administration. The effects of each of the antibiotics on palonosetron hydrochloride in these admixtures were tested in triplicate. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by high-performnace 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 study . The drug concentration was unchanged in all of the samples tested. Palonosetron hydrochloride is physically and chemically stable in admixtures with cefazolin sodium, cefotetan disodium and the combination ampicillin sodium-sulbactam sodium at the concentrations tested during simulated Y-site administration over 4 hours at ambient room temperature.