title: Pharmacokinetics, efficacy, and safety evaluation of docetaxel/hydroxypropyl-sulfobutyl-β-cyclodextrin inclusion complex.
abstract: Hydroxypropyl-sulfobutyl-β-cyclodextrin (HP-SBE-β-CD) inclusion complex was developed and used as a drug delivery system for DTX (DTX/HP-SBE-β-CD). The objective of the present study was to evaluate and compare the biological properties of DTX/HP-SBE-Β-CD with Taxotere®. The pharmacokinetics, biodistribution, antitumor efficacy in vivo and in vitro, and safety evaluation of DTX/HP-SBE-β-CD were studied. The most significant finding was that it was possible to prepare a Polysorbate-80-free inclusion complex for DTX. Studies based on pharmacokinetics, biodistribution, and antitumor efficacy indicated that DTX/HP-SBE-β-CD had similar pharmacokinetic properties and antitumor efficacy both in vitro and in vivo as Taxotere®. Fortunately, this new drug delivery system attenuated the side effects when used in vivo. As a consequence, DTX/HP-SBE-β-CD may be a promising alternative to Taxotere® for cancer chemotherapy treatment with reduced side effects. The therapeutic potential against a variety of human tumors and low toxicity demonstrated in a stringent study clearly warrant clinical investigation of DTX/HP-SBE-β-CD for possible use against human tumors.
authors.affiliation: Jiangsu Key Laboratory for Supramolecular Medicinal Materials and Applications, College of Life Sciences, Nanjing Normal University, China.
authors.forename: Xing-Xing
authors.initials: XX
authors.lastname: Huang
authors.forename: Cheng-Liang
authors.initials: CL
authors.lastname: Zhou
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.forename: Cheng
authors.initials: C
authors.lastname: Chen
authors.forename: Shu-Qin
authors.initials: SQ
authors.lastname: Yu
authors.forename: Qian
authors.initials: Q
authors.lastname: Xu
authors.forename: Yin-Yan
authors.initials: YY
authors.lastname: Zhu
authors.forename: Yong
authors.initials: Y
authors.lastname: Ren
mesh_terms: D000818:Animals; D000077143:Docetaxel; D016503:Drug Delivery Systems / Q000379:methods* / Q000592:standards; D045325:HCT116 Cells; D056945:Hep G2 Cells; D006801:Humans; D008297:Male; D051379:Mice; D009369:Neoplasms / Q000188:drug therapy / Q000473:pathology; D011817:Rabbits; D011897:Random Allocation; D051381:Rats; D017208:Rats, Wistar; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D016896:Treatment Outcome; D023041:Xenograft Model Antitumor Assays / Q000379:methods / Q000592:standards; D047392:beta-Cyclodextrins / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*
chemical_list: D043823:Taxoids; D047392:beta-Cyclodextrins; D000077143:Docetaxel; C093196:SBE4-beta-cyclodextrin