Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags.
OBJECTIVE
The physicochemical stability of extemporaneous dilutions of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride (PVC), polypropylene, and polyethylene infusion bags was studied.


METHODS
Oxaliplatin 100 mg/20 mL concentrated solution was diluted in 100 mL of 5% dextrose injection in PVC, polypropylene, and polyethylene infusion bags to produce nominal oxaliplatin concentrations of 0.2 and 1.3 mg/mL. The filled bags were stored for 14 days at 20 degrees C and protected from light, at 20 degrees C under normal fluorescent light, and at 4 degrees C. A 1-mL sample was removed from each bag at time 0 and at 24, 48, 72, 120, 168, and 336 hours. The samples were visually inspected for color and clarity, and the pH values of the solutions were measured. High-performance liquid chromatography was used to assay oxaliplatin concentration. Bacterial contamination was assessed on study day 14 after incubation in trypticase soy solution for three days at 37 degrees C.


RESULTS
Solutions of oxaliplatin 0.2 and 1.3 mg/mL in 5% dextrose injection were stable in the three container types for at least 14 days at both 4 degrees C and 20 degrees C without regard to light exposure. No color change was detected during the storage period, and pH values remained stable. No microbial contamination was detected in any samples over the study period.


CONCLUSIONS
Oxaliplatin solutions diluted in 5% dextrose injection to 0.2 and 1.3 mg/mL were stable in PVC and PVC-free infusion bags for at least 14 days at both 4 degrees C and 20 degrees C without regard to light exposure.
Department of Pharmacy and Pharmacology, Centre Régional de Lutte contre le Cancer Val d'Aurelle, University of Montpellier, Montpellier, France. eidenceline@yahoo.fr
Céline
C
Eiden
Laurent
L
Philibert
Khedidja
K
Bekhtari
Sylvain
S
Poujol
Francoise
F
Malosse
Frédéric
F
Pinguet
D000970:Antineoplastic Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose / Q000008:administration & dosage / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D009944:Organoplatinum Compounds / Q000737:chemistry*; D000077150:Oxaliplatin; D020959:Polyethylene; D011126:Polypropylenes; D011143:Polyvinyl Chloride; D012996:Solutions; D013696:Temperature; D013997:Time Factors
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D011126:Polypropylenes; D012996:Solutions; D000077150:Oxaliplatin; D011143:Polyvinyl Chloride; D020959:Polyethylene; D005947:Glucose