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American Journal of Health-System Pharmacy, Vol. 64, Issue 18, 1950-1954
Copyright © 2007 by American Society of Health-System Pharmacists
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American Journal of Health-System Pharmacy, Vol. 64, Issue 18, 1950-1954
Copyright © 2007. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

Practice Reports

Stability of oxaliplatin in infusion bags containing 5% dextrose injection

 Pascal André, Salvatore Cisternino, Anne-Lise Roy, Fouad Chiadmi, Joël Schlatter, Pascal Agranat, Olivier Fain and Jean-Eudes Fontan

PASCAL ANDRE is Pharmacy Intern; and SALVATORE CISTERNINO, PHARMD.,. PH.D., is Assistant, Department of Pharmacy and Toxicology, University Hospital of Jean Verdier (AP-HP), Bondy, France. ANNE-LISE ROY is a Ph.D. degree student, Laboratory of Organic Chemistry, Pierre and Marie Curie University, Paris, France. FOUAD CHIADMI, PHARM.D., is Assistant, Department of Pharmacy and Toxicology; JOEL SCHLATTER, PHARMD.,. is Senior Pharmacist, Department of Pharmacy and Toxicology; PASCAL AGRANAT, M.D., is Senior Oncologist, Department of Internal Medicine; OLIVIER FAIN, M.D., is Chief, Department of Internal Medicine; and JEAN-EUDES FONTAN, PHARM.D., is Chief, Department of Pharmacy and Toxicology, AP-HP.

Address correspondence to Dr. Cisternino at the Department of Pharmacy and Toxicology, University Hospital of Jean Verdier, AP-HP, Avenue du 14 Juillet, 93143 Bondy, Cedex, France (salvatore.cisternino{at}jvr.aphp.fr).


Purpose. The stability of oxaliplatin in infusion bags containing 5% dextrose injection was studied.

Methods. Solutions of oxaliplatin 0.7 mg/mL were prepared in polyolefin infusion bags containing 5% dextrose injection and stored at 3–7 °C in a lightproof bag, at 20–24 °C with continuous exposure to artificial light, and at 20–24 °C with continuous exposure to fluorescent light in a lightproof bag. Samples were analyzed at 1, 2, 3, 4, 5, 7, 14, and 30 days and assayed in duplicate. Stability was measured using a stability-indicating high-performance liquid chromatographic method. Samples were also examined for changes in color and pH and for the presence of particulate matter.

Results. All samples retained over 90% of their initial concentration over the study period. No color changes or visible precipitation was observed, and the pH of all samples remained stable. Neither temperature nor artificial light had any significant effect on the stability of oxaliplatin.

Conclusion. Oxaliplatin 0.7 mg/mL in infusion bags containing 5% dextrose injection was chemically stable for at least 30 days at both 3–7 °C and 20–24 °C without regard to light exposure.

Index terms: Antineoplastic agents; Color; Concentration; Containers; Contamination; Dextrose; Diluents; Hydrogen ion concentration; Injections; Oxaliplatin; Photodecomposition; Polyolefin; Precipitation; Stability; Storage; Temperature

 





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