title: Pharmacokinetic equivalence of Taxotere and SID530, a novel docetaxel formulation containing hydroxypropyl-beta-cyclodextrin in monkeys.
abstract: SID530 is a new parenteral formulation of docetaxel containing hydroxypropyl-beta-cyclodextrin (HP-β-CD). In this study, a comparative pharmacokinetic study of 2 docetaxel parenteral solutions, SID530 and Taxotere, was carried out. In a crossover experimental design, 6 male cynomolgus monkeys received each formulation by intravenous infusion of a single dose. The concentration of docetaxel in whole blood and plasma was determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The 2 formulations showed similar pharmacokinetic parameters in both whole blood and plasma, and displayed comparable values for maximum serum concentration (Cmax), time to peak concentration (Tmax), and area under the concentration-time curve (AUC). The 90% confidence intervals for the ratios of Cmax and AUC values for SID530 to Taxotere were within the acceptable range of 0.80-1.20 in both plasma and whole blood. These findings indicate that SID530 and Taxotere are comparable in terms of their distribution in the blood and their plasma profile; consequently, these drugs are bioequivalent in the monkey.
authors.affiliation: College of Pharmacy, Seoul National University, Seoul, Republic of Korea.
authors.forename: T K
authors.initials: TK
authors.lastname: Kim
authors.forename: H H
authors.initials: HH
authors.lastname: Yoo
authors.forename: E J
authors.initials: EJ
authors.lastname: Kim
authors.forename: B-Y
authors.initials: BY
authors.lastname: Lee
authors.forename: J H
authors.initials: JH
authors.lastname: Park
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D000077143:Docetaxel; D005079:Excipients; D008252:Macaca fascicularis; D008297:Male; D012015:Reference Standards; D053719:Tandem Mass Spectrometry; D043823:Taxoids / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D047392:beta-Cyclodextrins / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D005079:Excipients; C574494:SID530; D043823:Taxoids; D047392:beta-Cyclodextrins; D000077143:Docetaxel; D000073738:2-Hydroxypropyl-beta-cyclodextrin