Predicting pharmacokinetic behaviour of drug release from drug-eluting embolization beads using in vitro elution methods

European Journal of Pharmaceutical Sciences - Tập 136 - Trang 104943 - 2019
Alice Hagan1,2, Marcus Caine2, Cara Press2, Wendy M. Macfarlane1, Gary Phillips1, Andrew W. Lloyd1, Peter Czuczman2, Hugh Kilpatrick2, Zainab Bascal2, Yiqing Tang2, Pedro Garcia2, Andrew L. Lewis2
1School of Pharmacy and Biomolecular Sciences, University of Brighton, Moulsecoomb, Brighton, BN2 4GJ, UK
2Biocompatibles UK Ltd, a BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, GU15 3YL, UK

Tài liệu tham khảo

Ahnfelt, 2016, In vitro release mechanisms of doxorubicin from a clinical bead drug-delivery system, J. Pharm. Sci., 105, 3387, 10.1016/j.xphs.2016.08.011 Ahnfelt, 2018, Single bead investigation of a clinical drug delivery system – a novel release mechanism, J. Control. Release, 292, 235, 10.1016/j.jconrel.2018.11.011 Amyot, 2002, A new experimental method for the evaluation of the release profiles of drug-loaded microbeads designed for embolisation, ITBM-RBM, 23, 285, 10.1016/S1297-9562(02)80054-7 Andhariya, 2017, Development of in vitro-in vivo correlation of parenteral naltrexone loaded polymeric microspheres, J. Control. Release, 255, 27, 10.1016/j.jconrel.2017.03.396 Ashrafi, 2017, Characterization of a novel intrinsically radiopaque drug-eluting bead for image-guided therapy: DC bead LUMI™, J. Control. Release, 250, 36, 10.1016/j.jconrel.2017.02.001 Biondi, 2013, Investigation of the mechanisms governing doxorubicin and irinotecan release from drug-eluting beads: mathematical modeling and experimental verification, J. Mater. Sci. Mater. Med., 24, 2359, 10.1007/s10856-013-4992-4 Boulin, 2014, Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial, Aliment. Pharmacol. Ther., 39, 1301, 10.1111/apt.12746 Caine, 2017, Gel phantom for real-time in vitro spatiotemporal diffusion of doxorubicin from radiopaque and non-radiopaque drug eluting beads introduction, J. Vasc. Interv. Radiol., 28, e47 Caine, 2017, Review of the development of methods for characterization of microspheres for use in embolotherapy: translating Bench to Cathlab, Adv. Healthc. Mater., 6, 10.1002/adhm.201601291 Caine, 2017, Impact of yttrium-90 microsphere density, flow dynamics, and administration technique on spatial distribution: analysis using an in vitro model, J. Vasc. Interv. Radiol., 28, 260, 10.1016/j.jvir.2016.07.001 ClinicalTrials.gov de Baere, 2016, An in vitro evaluation of four types of drug-eluting microspheres loaded with doxorubicin, J. Vasc. Interv. Radiol., 27, 1425, 10.1016/j.jvir.2016.05.015 Denys, 2017, Vandetanib-eluting radiopaque beads: in vivo pharmacokinetics, safety and toxicity evaluation following swine liver embolization, Theranostics, 7, 2164, 10.7150/thno.19652 Drugbank Dubbelboer, 2014, The effects of lipiodol and cyclosporin A on the hepatobiliary disposition of doxorubicin in pigs, Mol. Pharm., 11, 1301, 10.1021/mp4007612 Duran, 2016, A novel inherently radiopaque bead for transarterial embolization to treat liver cancer - a pre-clinical study, Theranostics, 6, 28, 10.7150/thno.13137 Facciorusso, 2018, Drug-eluting beads transarterial chemoembolization for hepatocellular carcinoma: current state of the art, World J. Gastroenterol., 24, 161, 10.3748/wjg.v24.i2.161 FDA, 1997 Fuchs, 2014, Drug-eluting beads loaded with antiangiogenic agents for chemoembolization: in vitro sunitinib loading and release and in vivo pharmacokinetics in an animal model, J. Vasc. Interv. Radiol., 25, 379, 10.1016/j.jvir.2013.11.039 Fuchs, 2015, Sunitinib-eluting beads for chemoembolization: methods for in vitro evaluation of drug release, Int. J. Pharm., 482, 68, 10.1016/j.ijpharm.2014.11.041 Gonzalez, 2008, Doxorubicin eluting beads-2: methods for evaluating drug elution and in-vitro:in-vivo correlation, J. Mater. Sci. Mater. Med., 19, 767, 10.1007/s10856-006-0040-y Gustafson, 2002, Doxorubicin pharmacokinetics: macromolecule binding, metabolism, and excretion in the context of a physiologic model, J. Pharm. Sci., 91, 1488, 10.1002/jps.10161 Hagan, 2017, Preparation and characterisation of vandetanib-eluting radiopaque beads for locoregional treatment of hepatic malignancies, Eur. J. Pharm. Sci., 101, 22, 10.1016/j.ejps.2017.01.033 Jordan, 2010, Comparative study of chemoembolization loadable beads: in vitro drug release and physical properties of DC bead and hepasphere loaded with doxorubicin and irinotecan, J. Vasc. Interv. Radiol., 21, 1084, 10.1016/j.jvir.2010.02.042 Lahti, 2015, Sorafenib loaded drug-eluting beads: loading and eluting kinetics and in vitro viability study, J. Vasc. Interv. Radiol., 26, S80, 10.1016/j.jvir.2014.12.223 Lammer, 2010, Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study, Cardiovasc. Intervent. Radiol., 33, 41, 10.1007/s00270-009-9711-7 Lencioni, 2012, Chemoembolization for hepatocellular carcinoma, Semin. Oncol., 39, 503, 10.1053/j.seminoncol.2012.05.004 Lewis, 2009, DC Bead™: a major development in the toolbox for the interventional oncologist, Expert Rev. Med. Devices, 6, 389, 10.1586/erd.09.20 Martin, 2009, Transarterial chemoembolization of metastatic colorectal carcinoma with drug-eluting beads, irinotecan (DEBIRI): multi-institutional registry, J. Oncol., 2009, 10.1155/2009/539795 Martin, 2011, Hepatic intra-arterial injection of drug-eluting bead, irinotecan (DEBIRI) in unresectable colorectal liver metastases refractory to systemic chemotherapy: results of multi-institutional study, Ann. Surg. Oncol., 18, 192, 10.1245/s10434-010-1288-5 Martin, 2012, Optimal outcomes for liver-dominant metastatic breast cancer with transarterial chemoembolization with drug-eluting beads loaded with doxorubicin, Breast Cancer Res. Treat., 132, 753, 10.1007/s10549-011-1926-z Namur, 2010, Drug-eluting beads for liver embolization: concentration of doxorubicin in tissue and in beads in a pig model, J. Vasc. Interv. Radiol., 21, 259, 10.1016/j.jvir.2009.10.026 Nicolini, 2010, Transarterial chemoembolization with epirubicin-eluting beads versus transarterial embolization before liver transplantation for hepatocellular carcinoma, J. Vasc. Interv. Radiol., 21, 327, 10.1016/j.jvir.2009.10.038 Nicolini, 2011, Drug delivery embolization systems: a physician's perspective, Expert Opin. Drug Deliv., 8, 1071, 10.1517/17425247.2011.590472 Qureshi, 2010, In vitro-in vivo correlation (IVIVC) and determining drug concentrations in blood from dissolution testing - a simple and practical approach, Open Drug Delivery J., 4, 38, 10.2174/1874126601004020038 Reich, 1979, Mathematical model for adriamycin (doxorubicin) pharmacokinetics, Cancer Chemother. Pharmacol., 3, 125, 10.1007/BF00254984 Song, 2017, Conventional vs drug-eluting beads transarterial chemoembolization for hepatocellular carcinoma, World J. Hepatol., 9, 808, 10.4254/wjh.v9.i18.808 Swaine, 2016, Evaluation of ion exchange processes in drug-eluting embolization beads by use of an improved flow-through elution method, Eur. J. Pharm. Sci., 93, 351, 10.1016/j.ejps.2016.08.020 Taylor, 2007, Irinotecan drug eluting beads for use in chemoembolization: in vitro and in vivo evaluation of drug release properties, Eur. J. Pharm. Sci., 30, 7, 10.1016/j.ejps.2006.09.002