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American Journal of Health-System Pharmacy, Vol. 67, Issue 3, 223-226
Copyright © 2010 by American Society of Health-System Pharmacists
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Practice Report

Stability of cetuximab and panitumumab in glass vials and polyvinyl chloride bags

 Hiroaki Ikesue, Lee C. Vermeulen, Rita Hoke and Jill M. Kolesar

HIROAKI IKESUE, PH.D., is Clinical Pharmacist, Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan. LEE C. VERMEULEN, M.SC., FCCP, is Clinical Associate Professor, Division of Pharmacy Practice, School of Pharmacy, University of Wisconsin (UW)—Madison, Madison, and Director, Center for Drug Policy, UW Hospital and Clinics, Madison. RITA HOKE, M.SC., is General Manager, Hospital Division, Grifols USA, Los Angeles, CA. JILL M. KOLESAR, PHARM.D., BCPS, FCCP, is Professor, School of Pharmacy, UW—Madison, and Paul P. Carbone Comprehensive Cancer Center, UW

Address correspondence to Dr. Kolesar at the Paul P. Carbone Comprehensive Cancer Center, Room K4/554, University of Wisconsin—Madison, 600 Highland Avenue, Madison, WI 53705 (jmkolesar{at}pharmacy.wisc.edu).


Purpose. The stability of cetuximab and panitumumab in glass vials and polyvinyl chloride (PVC) bags stored at 4 °C for up to 14 days was studied.

Methods. Sixty milliliters of cetuximab was drawn directly from a commercially available vial, and 20 mL was injected into each of three sterile, empty, 100-mL PVC bags through a preattached 0.22-µm filter. Three milliliters of panitumumab and 21 mL of 0.9% sodium chloride injection were mixed, and 8 mL of the mixture was injected into each of three empty PVC bags through a preattached 0.22-µm filter. Samples were analyzed immediately after preparation and again after storage at 4 °C for 7 and 14 days. Cetuximab and panitumumab concentrations were measured using a modification of a previously described enzyme-linked immunosorbent assay method. Stability was defined as the mean concentrations of the test solutions being within assay variability of the initial concentration. Solution appearance and color were assessed by observing the samples against black and white backgrounds.

Results. The percentages of initial concentration of cetuximab and panitumumab were over 90% stored at 4 °C after 14 days. No changes in color or turbidity were observed in any of the vials and the prepared solutions.

Conclusion. Cetuximab 2 mg/mL was stable when stored for 14 days in a glass vial and in PVC bags at 4 °C. Panitumumab 20 mg/mL in a glass vial and 2.5 mg/mL in 0.9% sodium chloride injection in PVC bags was also stable when stored for 14 days at 4 °C.

Index terms: Antibodies; Cetuximab; Concentration; Containers; Diluents; Glass; Immunoassay; Injections; Panitumumab; Polyvinyl chloride; Sodium chloride; Stability; Storage

 

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