TY - JOUR T1 - Pharmaceutical Development of a Parenteral Formulation of the Investigational Anticancer Drug Clanfenur JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 89 LP - 95 VL - 51 IS - 2 AU - Jantine D. Jonkman-De Vries AU - Bart J. F. Van Den Bemt AU - Wim W. Ten Bokkel-Huinink AU - Willy J. M. Underberg AU - J. Jantina Kettenes-Van Den Bosch AU - Roland E. C. Henrar AU - Auke Bult AU - Jos H. Beijnen Y1 - 1997/03/01 UR - http://journal.pda.org/content/51/2/89.abstract N2 - A stable parenteral dosage form for the investigational cytotoxic drug clanfenur was designed, and the bulk drug was characterized by its nuclear magnetic resonance, mass spectrometry, infrared, and ultraviolet spectra. The 1H and 13C spectra show clanfenur to be a mixture of two stereoisomers. Because of poor solubility in aqueous solution and precipitation in co-solvent, surfactant, or emulsion systems, a two-pump infusion system was developed for intravenous administration. Clanfenur, solubilized in a Cremophor EL/ethanol (1:1, w/v) solution (concentration, 15 mg/mL), can be simultaneously infused with 5% dextrose infusion fluid. Total doses of up to 1,680 mg of clanfenur (and 56 g of Cremophor EL) theoretically can be administered to patients over a 6-hour period. From accelerated stability testing of clanfenur in the Cremophor EL/ethanol (1:1, w/v) formulation, a shelf life of 3.5 years at 4°C and of 4 months at 25°C is calculated. ER -