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.
OBJECTIVE
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 degrees 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 degrees C.


CONCLUSIONS
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 degrees C. Docetaxel stability in diluted solutions appears sensitive to slight changes in temperature and degree of agitation.
Eroles
Ana Aragones
AA
Pharmacy Service, Hospital Universitari Arnau de Vilanova, Institut de Recerca Biomèdica Lleida, 25198 Lleida, Spain.
Bafalluy
Irene Mangues
IM
Arnaiz
Joan Antoni Schoenenberger
JA
D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000737:chemistry* / Q000528:radiation effects; D002851:Chromatography, High Pressure Liquid; D000077143:Docetaxel; D004349:Drug Packaging; D004355:Drug Stability; D005898:Glass; D019999:Pharmaceutical Solutions; D011090:Polyenes; D012015:Reference Standards; D012965:Sodium Chloride; D043823:Taxoids / Q000008:administration & dosage / Q000737:chemistry* / Q000528:radiation effects; D014466:Ultraviolet Rays
D000972:Antineoplastic Agents, Phytogenic; D019999:Pharmaceutical Solutions; D011090:Polyenes; D043823:Taxoids; D000077143:Docetaxel; D012965:Sodium Chloride; C035051:PL 732