Physical and chemical stability of Taxotere(®) (docetaxel) one-vial (20 mg/ml) infusion solution following refrigerated storage

A one-vial formulation of the chemotherapy agent Taxotere(®) (docetaxel) is likely to be commercially available in some countries in 2010. Through control of two significant potential risk factors for crystallization—intervention into the infusion bag (by using a one-step technique) and temperature (by use of refrigerated storage)—it was postulated that the risk of precipitation would be reduced and the storage time of Taxotere(®) increased using the one-vial formulation versus the two-vial formulation. Furthermore, improved convenience and flexibility were anticipated as a result of the easier and quicker preparation associated with the one-vial formulation versus the two-vial formulation. The results of the physicochemical stability study presented here indicate that the one-vial formulation is indeed associated with reduced risk of precipitation of docetaxel. Moreover, refrigerated storage has been shown to extend the physical and chemical stability for up to seven days, versus 4 h for the currently approved two-vial formulation and 6 h for the one-vial formulation stored at room temperature. However, only physical and chemical stability have been assessed in this study.