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Arzneimittelforschung 2012; 62(06): 280-284
DOI: 10.1055/s-0032-1306305
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

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

T. K. Kim   *
1   College of Pharmacy, Seoul National University, Seoul, Republic of Korea
2   Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea
,
H. H. Yoo   *
3   College of Pharmacy, Hanyang University, Ansan, Gyeonggi-do, Republic of Korea
,
E. J. Kim
2   Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea
,
B.-Y. Lee
2   Life Science R&D Center, SK Chemicals, Seongnam, Gyeonggi-do, Republic of Korea
,
J. H. Park
1   College of Pharmacy, Seoul National University, Seoul, Republic of Korea
› Author Affiliations
Further Information

Publication History

received 03 January 2012

accepted 17 February 2012

Publication Date:
16 April 2012 (online)

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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.

Key words

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

*  These 2 authors contributed equally to this work.


 

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