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American Journal of Health-System Pharmacy, Vol. 66, Issue 17, 1565-1568
Copyright © 2009. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

Practice Reports

Stability of docetaxel diluted to 0.3 or 0.9 mg/mL with 0.9% sodium chloride injection and stored in polyolefin or glass containers

 Ana Aragones Eroles, Irene Mangues Bafalluy and Joan Antoni Schoenenberger Arnaiz

ANA ARAGONES EROLES, M.D., is Research Scientist; IRENE MANGUES BAFALLUY, PHARM.D., is Oncology Pharmacist; and JOAN ANTONI SCHOENENBERGER ARNAIZ, PHARM.D., is Director, Pharmacy Service, Hospital Universitari Arnau de Vilanova, Institut de Recerca Biomèdica Lleida, Lleida, Spain.

Address correspondence to Dr. Schoenenberger Arnaiz at the Pharmacy Service, Hospital Universitari Arnau de Vilanova, Institut de Recerca Biomèdica Lleida, Avda Alcalde Rovira Roure 80, 25198 Lleida, Spain (jas{at}arnau.scs.es).


Purpose. The stability of docetaxel diluted to 0.3 or 0.9 mg/mL with 0.9% sodium chloride injection and stored in polyolefin or glass containers was studied.

Methods. Vials of docetaxel injection concentrate were reconstituted with the entire contents of the solvent vial and carefully homogenized to avoid the formation of foam. Solutions were aseptically prepared with nominal docetaxel concentrations of 0.3 and 0.9 mg/mL by adding the appropriate quantities to polyolefin containers or glass bottles, to which had been added the appropriate volume of 0.9% sodium chloride injection, yielding a final volume of 50 mL. Three identical polyolefin containers and one control glass bottle for each concentration were prepared. All test solutions were stored at 19–21 °C and protected from light. Chemical stability was measured by using a stability-indicating high-performance liquid chromatographic (HPLC) assay with ultraviolet-light detection. Physical stability was determined by visual inspection.

Results. No evidence of precipitation was observed during the first 24 hours of the study. However, after a day of storage, the HPLC assay revealed large relative standard deviation values for diluted docetaxel solutions in some containers. These values were predictive for the formation of precipitates and compatible with the existence of microprecipitates at 24 hours. These results suggest that the diluted docetaxel infusions were not stable when stored at 19–21 °C.

Conclusion. Docetaxel 0.3 and 0.9 mg/mL in 0.9% sodium chloride injection was not physically stable for more than one day when stored at 19–21 °C. Docetaxel stability in diluted solutions appears sensitive to slight changes in temperature and degree of agitation.

Index terms: Antineoplastic agents; Chromatography, liquid; Concentration; Containers; Diluents; Docetaxel; Glass; Polyolefin; Precipitation; Sodium chloride; Stability; Storage; Temperature

 

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