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Original Research

Bioequivalence of paclitaxel protein-bound particles in patients with breast cancer: determining total and unbound paclitaxel in plasma by rapid equilibrium dialysis and liquid chromatography–tandem mass spectrometry

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Pages 1739-1749 | Published online: 20 May 2019

References

  • Vidensek N, Lim P, Campbell A, Carlson C. Taxol content in bark, wood, root, leaf, twig, and seedling from several taxus species. J Nat Prod. 1990;53(6):1609−1610. doi:10.1021/np50072a0391982448
  • Adams JD, Flora KP, Goldspiel BR, et al. Taxol: a history of pharmaceutical development and current pharmaceutical concerns. J Natl Cancer Inst Monogr. 1993;(15):141–147.7912520
  • Riondel J, Jacrot M, Picot F, Beriel H, Mouriquand C, Potier P.Therapeutic response to taxol of six human tumors xenografted into nude mice. Cancer Chemother Pharmacol. 1986;17(2):137–142. doi:10.1007/BF003067422872974
  • Rowinsky EK, Cazenave LA, Donehower RC. Taxol: a novel investigational antimicrotubule agent. J Natl Cancer Inst. 1990;82(15):1247–1259.1973737
  • Sparreboom A, Van AJ, Mayer U, et al. Limited oral bioavailability and active epithelial excretion of paclitaxel (Taxol) caused by P-glycoprotein in the intestine. Proc Natl Acad Sci U S A. 1997;94(5):2031–2035. doi:10.1073/pnas.94.5.20319050899
  • Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001;37(13):1590–1598. doi:10.1016/S0959-8049(01)00171-X11527683
  • Kong L, Askes SHC, Bonnet S, Kros A, Campbell F. Temporal control of membrane fusion through photolabile PEGylation of liposome membranes. Angew Chem Int Ed. 2016;55(4):1396–1400. doi:10.1002/anie.201509673
  • Sharma N, Madan P, Lin S. Effect of process and formulation variables on the preparation of parenteral paclitaxel-loaded biodegradable polymeric nanoparticles: a co-surfactant study. Asian J Pharm Sci. 2016;11(3):404–416. doi:10.1016/j.ajps.2015.09.004
  • Han X, Chen J, Jiang M, et al. Paclitaxel–paclitaxel prodrug nanoassembly as a versatile nanoplatform for combinational cancer therapy. ACS Appl Mater Interfaces. 2016;8(49):33506–33513. doi:10.1021/acsami.6b1305727960378
  • Sofias AM, Dunne M, Storm G, Allen C. The battle of “nano” paclitaxel. Adv Drug Delivery Rev. 2017;122:20–30. doi:10.1016/j.addr.2017.02.003
  • Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794–7803. doi:10.1200/JCO.2005.04.93716172456
  • Cheng HR, Guan H, Chen J. Efficacy and safety of abraxane and paclitaxel liposome in treatment of recurrent ovarian cancer. J Pract Obstet Gynecol. 2015;31(3):229–232.
  • Gradishar WJ, Krasnojon D, Cheporov S, et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009;27(22):3611–3619. doi:10.1200/JCO.2008.18.539719470941
  • Desai N, Trieu V, Damascelli B, et al. SPARC expression correlates with tumor response to albumin-bound paclitaxel in head and neck cancer patients. Transl Oncol. 2009;2(2):59–64.19412420
  • Gradishar WJ. Albumin-bound paclitaxel: a next-generation taxane. Expert Opin Pharmacother. 2006;7(8):1041–1053. doi:10.1517/14656566.7.8.104116722814
  • Desai N. Nab technology: a drug delivery platform utilizing endothelial gp60 receptor-based transport and tumor-derived SPARC for targeting. Drug Deliv Rep. 2007;37–41.
  • Desai N. Nanoparticle Albumin-Bound Anticancer Agents. In: Crommelin D., de Vlieger J. (eds) Non-Biological Complex Drugs Non-Biological Complex Drugs. AAPS Advances in the Pharmaceutical Sciences Series, Springer, Cham; 2015;20:335–354
  • Stern ST, Martinez MN, Stevens DM. When is it important to measure unbound drug in evaluating nanomedicine pharmacokinetics? Drug Metabo Dispos. 2016;44(12):1934–1939. doi:10.1124/dmd.116.073148
  • Gardner ER, Dahut WL, Scripture CD, et al. Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Clin Cancer Res. 2008;14(13):4200–4205. doi:10.1158/1078-0432.CCR-07-459218594000
  • Pacifici GM, Viani A. Methods of determining plasma and tissue binding of drugs. Pharmacokinetic consequences. Clin Pharmacokinet. 1992;23(6):449–468. doi:10.2165/00003088-199223060-000051458763
  • Guo J, Zhang Y, Huo Y, Chang Y-X, Liu E-W, Hao J. Monitoring unbound warfarin in drug combination therapy by pharmacokinetics and fluorospectrometry. Chin Herbal Med. 2019;11(1):92–97. doi:10.1016/j.chmed.2018.10.002
  • Tsai TH. Chapter 6.5 Assaying protein-unbound drugs using microdialysis techniques. Tech Behav Neural Sci. 2006;16:573–587.
  • Waters NJ, Jones R, Williams G, Sohal B. Validation of a rapid equilibrium dialysis approach for the measurement of plasma protein binding. J Pharm Sci. 2010;97(10):4586–4595. doi:10.1002/jps.21317
  • Food and Drug Administration (FDA). Contains nonbinding recommendations: draft guidance on paclitaxel; 2012 Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320015.pdf.Recommended. Accessed October 22, 2017.
  • Committee for Proprietary Medicinal Products (CPMP),The European Agency for the Evaluation of Medicinal Products (EMA). Note for Guidance on the Investigation of Bioavailability and Bioequivalence.CPMP/EWP/QWP/1401/98Rev.1; 2010 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientifc_guideline/2010/01/WC500070039. Accessed 87, 2013.
  • Food and Drug Administration (FDA). Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA; 2013 Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf. Accessed October 22, 2017.
  • Li QM, Zhang H, Zhu XX, et al. Tolerance, variability and pharmacokinetics of albumin-bound paclitaxel in chinese breast cancer patients. Front Pharmacol. 2018;9:1372. doi:10.3389/fphar.2018.0137230559662
  • Kumar GN, Walle UK, Bhalla KN, et al. Binding of taxol to human plasma, albumin and alpha 1-acid glycoprotein. Res Commun Chem Pathol Pharmacol. 1993;80(3):337–344.8102493
  • Brouwer E, Verweij J, De Bruijn P, et al. Measurement of fraction unbound paclitaxel in human plasma[J]. Drug Metab Dispos. 2000;28(10):1141–1145.10997930
  • Sottani C, Minoia C, D’Incalci M, Paganini M, Zucchetti M. High‐performance liquid chromatography tandem mass spectrometry procedure with automated solid phase extraction sample preparation for the quantitative determination of paclitaxel (Taxol®) in human plasma. Rapid Commun Mass Spectrom. 1998;12(5):251–255. doi:10.1002/(ISSN)1097-02319519477
  • Parise RA, Ramanathan RK, Zamboni WC, Egorin MJ. Sensitive liquid chromatography-mass spectrometry assay for quantitation of docetaxel and paclitaxel in human plasma. J Chromatogr B. 2003;783(1):231–236. doi:10.1016/S1570-0232(02)00659-1
  • Mortier KA, Renard V, Verstraete AG, Van Gussem A, Van Belle S, Lambert WE. Development and validation of a liquid chromatography−tandem mass spectrometry assay for the quantification of docetaxel and paclitaxel in human plasma and oral fluid. Anal Chem. 2005;77(14):4677–4683. doi:10.1021/ac050094116013889
  • Zhang SQ, Chen GH. Determination of paclitaxel in human plasma by UPLC–MS–MS. J Chromatogr Sci. 2008;46(3):220–224. doi:10.1093/chromsci/46.3.22018334088
  • Fan YX, Chen XY, Ma ZY, et al. Determination of paclitaxel and hydroxylated metabolites in rat plasma with lithium adduct ion by LC–MS/MS. J Chin Mass Spectr Soc. 2013;34(3):137–144.
  • Wu HL, Ma ZY, Zhang SQ, et al. Effects of different formulations on plasma free concentration of paclitaxel in rats. Chin J Pharm. 2016;47(11):1430–1435.
  • Gardner ER, Dahut W, Figg WD. Quantitative determination of total and unbound paclitaxel in human plasma following Abraxane treatment. J Chromatogr B. 2008;862:213–218. doi:10.1016/j.jchromb.2007.12.013
  • Bulitta JB, Zhao P, Arnold RD, et al. Mechanistic population pharmacokinetics of total and unbound paclitaxel for a new nanodroplet formulation versus Taxol in cancer patients. Cancer Chemother Pharmacol. 2009;63(6):1049–1063. doi:10.1007/s00280-008-0827-218791718
  • Li S, Liao H, Zhan J, et al. Comparison the pharmacokinetics of nanoparticle albumin bound paclitaxel and solvent based paclitaxel in breast cancer patients. Chin J Clin Pharmacol. 2010;26(8):606–610.
  • Bian L, Geng CZ, Ouyang QC, et al. Study of bioequiavailability of paclitaxel for injection (Albumin Bound) and abraxane and the efficacy of extension treatments in patients with metastatic breast cancer. Natl Med J China. 2018;98(16):1236–1241.
  • Mosteller RD. Simplified calculation of body surface area. N Engl J Med. 1987;317:1098. doi:10.1056/NEJM1987071631703013657876
  • Mortier KA, Lambert WE. Determination of unbound docetaxel and paclitaxel in plasma by ultrafiltration and liquid chromatography-tandem mass spectrometry. J Chromatog A. 2006;1108(2):195–201. doi:10.1016/j.chroma.2005.12.10316472531