Physico-chemical stability of docetaxel premix solution and docetaxel infusion solutions in PVC bags and polyolefine containers

We assessed the physical and chemical stability of docetaxel infusion solut ions. Stability of the antineoplastic drug was determined 1.) after reconst itution of the injection concentrate and 2.) after further dilution in two commonly used vehicle-solutions, 0.9% sodium chloride and 5% dextrose, in P VC bags and polyolefine containers. Chemical stability was measured by usin g a stability-indicating HPLC assay with ultraviolet detection. Physical st ability was determined by visual inspection. The stability tests revealed t hat reconstituted docetaxel solutions (= premix solutions) are physico-chem ically stable (at a level greater than or equal to 95% docetaxel) for a min imum of four weeks, independent of the storage temperature (refrigerated, r oom temperature). Diluted infusion solutions (docetaxel concentration 0.3 m g/ml and 0.9 mg/ml), with either vehicle-solution, proved physico-chemicall y stable (at a level greater than or equal to 95% docetaxel) for a minimum of four weeks, when prepared in polyolefine containers and stored at room t emperature. However, diluted infusion solutions exhibited limited physical stability in PVC bags, because docetaxel precipitation occured irregularly, though not before day 5 of storage. In addition, time-dependent DEHP-leach ing from PVC infusion bags by docetaxel infusion solutions must be consider ed.