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LAWRENCE A. TRISSEL, B.S., FASHP, is Research Consultant, TriPharma Research, Cashiers, NC. CRAIG TRUSLEY, PHARM.D., is Research Analyst; MICHEL BEN, M.S., is Research Analyst; and THOMAS C. KUPIEC, PH.D., is Chief Executive Officer, Analytical Research Laboratories, Oklahoma City, OK.

Address correspondence to Mr. Trissel at TriPharma Research, P.O. Box 265, Cashiers, NC 28717-0265 (tripharma{at}mail.com).

Purpose. The physical and chemical compatibility of palonosetron hydrochloride with fentanyl citrate, hydromorphone hydrochloride, meperidine hydrochloride, morphine sulfate, and sufentanil citrate during simulated Y-site administration was studied. Methods. Test samples were prepared in triplicate by mixing 7.5-mL samples of undiluted palonosetron 50 µg/mL (of palonosetron) with 7.5-mL samples of fentanyl citrate 50 µg/mL, morphine sulfate 15 mg/mL, hydromorphone hydrochloride 0.5 mg/mL, meperidine hydrochloride 10 mg/mL, and sufentanil citrate 12.5 µg/mL (of sufentanil) per milliliter individually in colorless 15-mL borosilicate glass screw-cap culture tubes with polypropylene caps. Physical stability of the admixtures was assessed by visual examination and by measuring turbidity and particle size and content. Chemical stability was assessed by stability-indicating high-performance liquid chromatography. Evaluations were performed immediately and one and four hours after mixing. Results. All of the admixtures were initially clear and colorless in normal fluorescent room light and when viewed with a high-intensity monodirectional light (Tyndall beam) and were essentially without haze. Changes in turbidity were minor throughout the study. Particulates measuring 10 µm or larger were few in all samples throughout the observation period. The admixtures remained colorless throughout the study. No loss of palonosetron hydrochloride occurred with any of the opiate agonists tested over the four-hour period. Similarly, little or no loss of the opiate agonists occurred over the four-hour period. Conclusion. Palonosetron hydrochloride was physically and chemically stable with fentanyl citrate, hydromorphone hydrochloride, meperidine hydrochloride, morphine sulfate, and sufentanil citrate during simulated Y-site administration. Index terms: Antiemetics; Closures; Color; Concentration; Containers; Contamination; Fentanyl citrate; Glass; Hydromorphone hydrochloride; Incompatibilities; Injections; Meperidine hydrochloride; Morphine sulfate; Opiate agonists; Palonosetron hydrochloride; Particle size; Polypropylene; Stability; Storage; Sufentanil citrate; Turbidity

 

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				T. C. Kupie, C. Trusley, M. Ben, and L. A. Trissel Physical and chemical stability of palonosetron hydrochloride with five common parenteral drugs during simulated Y-site administration Am. J. Health Syst. Pharm., September 15, 2008; 65(18): 1735 - 1759. [Abstract] [Full Text] [PDF]