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 solutions. Stability of the antineoplastic drug was determined 1.) after reconstitution of the injection concentrate and 2.) after further dilution in two commonly used vehicle-solutions, 0.9% sodium chloride and 5% dextrose, in PVC bags and polyolefine containers. Chemical stability was measured by using a stability-indicating HPLC assay with ultraviolet detection. Physical stability was determined by visual inspection. The stability tests revealed that reconstituted docetaxel solutions (= premix solutions) are physico-chemically stable (at a level > or = 95% docetaxel) for a minimum of four weeks, independent of the storage temperature (refrigerated, room temperature). Diluted infusion solutions (docetaxel concentration 0.3 mg/ml and 0.9 mg/ml), with either vehicle-solution, proved physico-chemically stable (at a level > or = 95% docetaxel) for a minimum of four weeks, when prepared in polyolefine containers and stored at room temperature. However, diluted infusion solutions exhibited limited physical stability in PVC bags, because docetaxel precipitation occurred irregularly, though not before day 5 of storage. In addition, time-dependent DEHP-teaching from PVC infusion bags by docetaxel infusion solutions must be considered.
Thiesen
J
J
Department of Pharmacy, J. Gutenberg University Hospital, Germany.
Krämer
I
I
D000972:Antineoplastic Agents, Phytogenic / Q000032:analysis*; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D002851:Chromatography, High Pressure Liquid; D000077143:Docetaxel; D004349:Drug Packaging; D004355:Drug Stability; D005898:Glass; D007262:Infusions, Intravenous; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000032:analysis; D019999:Pharmaceutical Solutions; D010969:Plastics; D011090:Polyenes; D043823:Taxoids
D000972:Antineoplastic Agents, Phytogenic; D019999:Pharmaceutical Solutions; D010969:Plastics; D011090:Polyenes; D043823:Taxoids; D000077143:Docetaxel; C035051:PL 732; D017239:Paclitaxel