RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 89
OP 95
VO 51
IS 2
A1 Jantine D. Jonkman-De Vries
A1 Bart J. F. Van Den Bemt
A1 Wim W. Ten Bokkel-Huinink
A1 Willy J. M. Underberg
A1 J. Jantina Kettenes-Van Den Bosch
A1 Roland E. C. Henrar
A1 Auke Bult
A1 Jos H. Beijnen
YR 1997
UL http://journal.pda.org/content/51/2/89.abstract
AB 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.