Pharmacokinetic Equivalence of Taxotere and SID530, a Novel Docetaxel Formulation Containing Hydroxypropyl-beta-cyclodextrin in Monkeys

T. K. Kim; H. H. Yoo; E. J. Kim; B.-Y. Lee; J. H. Park

doi:10.1055/s-0032-1306305

Arzneimittelforschung, Inhaltsverzeichnis

Arzneimittelforschung 2012; 62(06): 280-284
DOI: 10.1055/s-0032-1306305

Original Article

Pharmacokinetic Equivalence of Taxotere and SID530, a Novel Docetaxel Formulation Containing Hydroxypropyl-beta-cyclodextrin in Monkeys

T. K. Kim^*

¹College of Pharmacy, Seoul National University, Seoul, Republic of Korea

²Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea

,

H. H. Yoo^*

³College of Pharmacy, Hanyang University, Ansan, Gyeonggi-do, Republic of Korea

,

E. J. Kim

²Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea

,

B.-Y. Lee

²Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea

,

J. H. Park

¹College of Pharmacy, Seoul National University, Seoul, Republic of Korea

› Institutsangaben

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 (C_max), time to peak concentration (T_max), and area under the concentration-time curve (AUC). The 90% confidence intervals for the ratios of C_max 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.

Key words

docetaxel - bioequivalence - HP-β-CD - polysorbate 80 - LC-MS/MS

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Referenzen

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