Physical and chemical stability of palonosetron hydrochloride with Fluorouracil and with gemcitabine hydrochloride during simulated y-site administration.
The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron 50 micrograms/mL as the hydrochloride with fluorouracil 16 mg/mL, and with gemcitabine 10 mg/mL as the hydrochloride, in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of the fluorouacil and gemcitabine hydrochloride admixtures. 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 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, fluorouracil, and gemcitabine hydrochloride remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is physically compatible and chemically stable with fluorouracil and with gemcitabine hydrochloride during simulated Y-site administration.
Clinical Pharmaceutics Research, Division of Pharmacy, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.
Lawrence A
LA
Trissel
Yanping
Y
Zhang