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QUANYUN A. XU, PH.D., is Research Scientist and LAWRENCE A. TRISSEL, B.S., is Director, Clinical Pharmaceutics Research, Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston.

Address correspondence to Mr. Trissel at the Division of Pharmacy, Box 90, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.

Purpose. The physical and chemical compatibility of palonosetron with cyclophosphamide and with ifosfamide during simulated Y-site administration was studied. Methods. Test samples were prepared in triplicate by mixing 7.5 mL of palonosetron hydrochloride 50 µg (of palonosetron) per milliliter with 7.5 mL of cyclophosphamide 10 mg/mL and with ifosfamide 20 mg/mL. Physical stability was assessed by turbidimetry, particle sizing, and visual inspection. Chemical stability was assessed by stability-indicating high-performance liquid chromatography. Evaluations were performed immediately and one and four hours after mixing. Results. The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a high-intensity monodirectional light. Turbidity remained unchanged, and particulate content was low and exhibited little change. Palonosetron, cyclophosphamide, and ifosfamide remained chemically stable throughout the four-hour test period. Conclusion. Palonosetron hydrochloride was physically compatible with cyclophosphamide or ifosfamide during simulated Y-site administration. Index terms: Antiemetics; Antineoplastic agents; Cyclophosphamide; Ifosfamide; Incompatibilities; Injections; Palonosetron hydrochloride; Particle size; Stability; Storage; Turbidity

 

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