971
Views
26
CrossRef citations to date
0
Altmetric
Research Article

Investigation of factors affecting in vitro doxorubicin release from PEGylated liposomal doxorubicin for the development of in vitro release testing conditions

, , , &
Pages 1376-1386 | Received 25 Mar 2014, Accepted 10 Aug 2014, Published online: 29 Aug 2014

References

  • Uchegbu IF, Siew A. Nanomedicines and nanodiagnostics come of age. J Pharm Sci 2013;102:305–10
  • Kostarelos K. Rational design and engineering of delivery systems for therapeutics: biomedical exercises in colloid and surface science. Adv Colloid Interface Sci 2003;106:147–68
  • Schellekens H, Klinger E, Muhlebach S, et al. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol 2011;59:176–83
  • Schellekens H, Stegemann S, Weinstein V, et al. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. AAPS J 2014;16:15–21
  • FDA. Draft Guidance on Doxorubicin Hydrochloride. UCM199635. Recommended Feb 2010; Revised Nov 2013. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199635.pdf
  • EMA. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an inovator liposomal product. 21 February 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109479.pdf
  • Safra T, Muggia F, Jeffers S, et al. Pegylated liposomal doxorubicin (doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2. Ann Oncol 2000;11:1029–33
  • Barenholz Y. Doxil® – the first FDA-approved nano-drug: lessons learned. J Control Release 2012;160:117–34
  • Haran G, Cohen R, Bar LK, Barenholz Y. Transmembrane ammonium sulfate gradients in liposomes produce efficient and stable entrapment of amphipathic weak bases. Biochim Biophys Acta 1993;1151:201–15
  • Jiang W, Lionberger R, Yu LX. In vitro and in vivo characterizations of PEGylated liposomal doxorubicin. Bioanalysis. 2011;3:333–44
  • Charrois GJ, Allen TM. Drug release rate influences the pharmacokinetics, biodistribution, therapeutic activity, and toxicity of pegylated liposomal doxorubicin formulations in murine breast cancer. Biochim Biophys Acta 2004;1663:167–77
  • Burgess DJ, Crommelin DJ, Hussain AS, Chen ML. Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report. AAPS Pharm Sci 2004;6:100–11
  • Burgess DJ, Hussain AS, Ingallinera TS, Chen ML. Assuring quality and performance of sustained and controlled release parenterals: workshop report. AAPS Pharm Sci 2002;4:13–23
  • Siewert M, Dressman J, Brown CK, Shah VP. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 2003;4:43–52
  • Shabbits JA, Chiu GN, Mayer LD. Development of an in vitro drug release assay that accurately predicts in vivo drug retention for liposome-based delivery systems. J Control Release 2002;84:161–70
  • Amselem S, Cohen R, Barenholz Y. In vitro tests to predict in vivo performance of liposomal dosage forms. Chem Phys Lipids 1993;64:219–37
  • Yamamoto E, Hyodo K, Ohnishi N, et al. Direct, simultaneous measurement of liposome-encapsulated and released drugs in plasma by on-line SPE-SPE-HPLC. J Chromatogr B Analyt Technol Biomed Life Sci 2011;879:3620–5
  • Peschka R, Dennehy C, Szoka FC Jr. A simple in vitro model to study the release kinetics of liposome encapsulated material. J Control Release 1998;56:41–51
  • Bhardwaj U, Burgess DJ. A novel USP apparatus 4 based release testing method for dispersed systems. J Pharm Sci 2010;388:287–94
  • Abdel-Mottaleb MM, Lamprecht A. Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I. Drug Dev Ind Pharm 2011;37:178–84
  • Lee RJ, Wang S, Turk MJ, Low PS. The effects of pH and intraliposomal buffer strength on the rate of liposome content release and intracellular drug delivery. Biosci Rep 1998;18:69–78
  • Shibata H, Yomota C, Okuda H. Simultaneous determination of polyethylene glycol-conjugated liposome components by using reversed-phase high-performance liquid chromatography with UV and evaporative light scattering detection. AAPS PharmSciTech 2013;14:811–17
  • Maitani Y, Soeda H, Junping W, Takayama K. Modified ethanol injection method for liposomes containing beta-sitosterol beta-d-glucoside. J Liposome Res 2001;11:115–25
  • Maurer-Spurej E, Wong KF, Maurer N, et al. Factors influencing uptake and retention of amino-containing drugs in large unilamellar vesicles exhibiting transmembrane pH gradients. Biochim Biophys Acta 1999;1416:1–10
  • Hioki A, Wakasugi A, Kawano K, et al. Development of an in vitro drug release assay of PEGylated liposome using bovine serum albumin and high temperature. Biol Pharm Bull 2010;33:1466–70
  • Shibata H, Saito H, Yomota C, Kawanishi T. Ammonium ion level in serum affects doxorubicin release from liposomes. Pharmazie 2010;65:251–3
  • Volk T, Jahde E, Fortmeyer HP, et al. pH in human tumour xenografts: effect of intravenous administration of glucose. Br J Cancer 1993;68:492–500
  • Martin GR, Jain RK. Noninvasive measurement of interstitial pH profiles in normal and neoplastic tissue using fluorescence ratio imaging microscopy. Cancer Res 1994;54:5670–4
  • Schroeder A, Avnir Y, Weisman S, et al. Controlling liposomal drug release with low frequency ultrasound: mechanism and feasibility. Langmuir 2007;23:4019–25
  • Schroeder A, Kost J, Barenholz Y. Ultrasound, liposomes, and drug delivery: principles for using ultrasound to control the release of drugs from liposomes. Chem Phys Lipids 2009;162:1–16
  • Chen J, Cheng D, Li J, et al. Influence of lipid composition on the phase transition temperature of liposomes composed of both DPPC and HSPC. Drug Dev Ind Pharm 2013;39:197–204
  • Yamauchi M, Tsutsumi K, Abe M. Release of drugs from liposomes varies with particle size. Biol Pharm Bull 2007;30:963–6
  • Inoue K, Kitagawa T. Effect of exogenous lysolecithin on liposomal membranes. Its relation to membrane fluidity. Biochim Biophys Acta 1974;363:361–72
  • Zhang JA, Pawelchak J. Effect of pH, ionic strength and oxygen burden on the chemical stability of EPC/cholesterol liposomes under accelerated conditions. Part 1: Lipid hydrolysis. Eur J Pharm Biopharm 2000;50:357–64
  • Zuidam NJ, Gouw HK, Barenholz Y, Crommelin DJ. Physical (in) stability of liposomes upon chemical hydrolysis: the role of lysophospholipids and fatty acids. Biochim Biophys Acta 1995;1240:101–10
  • Lasic DD, Ceh B, Stuart MC, et al. Transmembrane gradient driven phase transitions within vesicles: lessons for drug delivery. Biochim Biophys Acta 1995;1239:145–56
  • Fritze A, Hens F, Kimpfler A, et al. Remote loading of doxorubicin into liposomes driven by a transmembrane phosphate gradient. Biochim Biophys Acta 2006;1758:1633–40
  • Nakamura K, Yoshino K, Yamashita K, Kasukawa H. Designing a novel in vitro drug-release-testing method for liposomes prepared by pH-gradient method. Int J Pharm 2012;430:381–7
  • Davidsen J, Mouritsen OG, Jorgensen K. Synergistic permeability enhancing effect of lysophospholipids and fatty acids on lipid membranes. Biochim Biophys Acta 2002;1564:256–62
  • Li X, Hirsh DJ, Cabral-Lilly D, et al. Doxorubicin physical state in solution and inside liposomes loaded via a pH gradient. Biochim Biophys Acta 1998;1415:23–40
  • FDA. Draft Guidance on Risperidone. UCM201272. Recommended Feb 2010, Revised Aug 2013. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201272.pdf
  • Evjen TJ, Nilssen EA, Fowler RA, et al. Lipid membrane composition influences drug release from dioleoylphosphatidylethanolamine-based liposomes on exposure to ultrasound. Int J Pharm 2011;406:114–16
  • Rawat A, Stippler E, Shah VP, Burgess DJ. Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal Consta. Int J Pharm 2011;420:198–205

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.