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Physical and chemical stability of palonosetron HCl with cisplatin, carboplatin, and oxaliplatin during simulated Y-site administration

Clinical Pharmaceutics Research, Division of Pharmacy, University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA

Yanping Zhang, BSc

Clinical Pharmaceutics Research, Division of Pharmacy, University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA

The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron HCl 50 mcg/mL with cisplatin 0.5 mg/mL, carboplatin 5 mg/mL, and with oxaliplatin 0.5 mg/mL in infusion solutions during simulated Y-site administration.

Triplicate test samples were prepared by admixing 7.5 mL of palonosetron HCl with 7.5 mL of the cisplatin, carboplatin, and oxaliplatin dilutions. Physical stability was assessed using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed using stability-indicating HPLC analytical techniques based on the determination of drug concentrations. Evaluations were performed initially upon mixing and 1 and 4 hours after mixing.

The samples were clear and colourless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity remained unchanged and particulate content was low and exhibited little change. HPLC analysis found palonosetron HCl, cisplatin, carboplatin, and oxaliplatin remained stable throughout the 4-hour test with no drug loss.

Palonosetron HCl is physically compatible and chemically stable with cisplatin, carboplatin, and oxaliplatin during Y-site administration.

Key Words: carboplatin • cisplatin • compatibility • oxaliplatin • palonosetron • stability

Journal of Oncology Pharmacy Practice, Vol. 10, No. 4, 191-195 (2004)
DOI: 10.1191/1078155204jp136oa


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