Nanotherapeutics in the EU: An overview on current state and future directions

International Journal of Nanomedicine

Volumn 9, Issue 1, 2014, Pages 1005-1023

  Hafner, Anita ^a   Lovrić, Jasmina ^a   Lakǒ, Gorana Perina ^b   Pepić, Ivan ^a  

^a UNIVERSITY OF ZAGREB   (Croatia)

^b Agency for Medicinal Products and Medical Devices   (Croatia)

Author keywords

Drug delivery; EU approval procedures; EU marketed products; Nanotechnology

Indexed keywords

FERRIC HYDROXIDE; IRON COMPLEX; LIPOSOME; NANOCRYSTAL; POLYMER; VIROSOME; COLLOID; EMULSION; IRON; MICELLE; NANOPARTICLE;

COST UTILITY ANALYSIS; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RESEARCH; MARKETING; MICELLE; NANOEMULSION; NANOMEDICINE; PARTICLE SIZE; PRODUCT DEVELOPMENT; PUBLIC HEALTH PROBLEM; REVIEW; RISK BENEFIT ANALYSIS; TREND STUDY; COLLOID; EMULSION; EUROPEAN UNION; HUMAN; LEGISLATION AND JURISPRUDENCE; NANOTECHNOLOGY; TRANSLATIONAL RESEARCH; TRENDS;

COLLOIDS; DRUG DELIVERY SYSTEMS; EMULSIONS; EUROPEAN UNION; HUMANS; IRON; LIPOSOMES; MICELLES; NANOMEDICINE; NANOPARTICLES; NANOTECHNOLOGY; TRANSLATIONAL MEDICAL RESEARCH; VIROSOMES;

EID: 84896882788     PISSN: 11769114     EISSN: 11782013     Source Type: Journal    
DOI: 10.2147/IJN.S55359     Document Type: Review

References (90)

1. Murthy SK. Nanoparticles in modern medicine: state of the art and future challenges. Int J Nanomedicine. 2007;2(2):129-141.
2. Mura S, Couvreur P. Nanotheranostics for personalized medicine. Adv Drug Deliv Rev. 2012;64(13):1394-1416.
3. Rizzo LY, Theek B, Storm G, Kiessling F, Lammers T. Recent progress in nanomedicine: therapeutic, diagnostic and theranostic applications. Curr Opin Biotechnol. 2013;24(6):1159-1166.
4. Wagner W, Nusn B, Gaisser S, Bock A. Nanomedicine: drivers for development and possible impacts. Centre ECJR, Studies IfPT, trans: European Commission Joint Research Centre, Institute for Prospective Technological Studies; 2006.
5. Webster TJ. Projections for nanomedicine into the next decade: but is it all about pharmaceuticals? Int J Nanomedicine. 2008;3(1):i.
6. Huber FX, McArthur N, Heimann L, et al. Evaluation of a novel nanocrystalline hydroxyapatite paste Ostim in comparison to Alpha- BSM -more bone ingrowth inside the implanted material with Ostim compared to Alpha BSM. BMC Musculoskelet Disord. 2009;10:164.
7. Pepí I, Hafner A, Lovrí J, Pirkí B, Filipoví-Gřić J. A non-ionic surfactant/chitosan micelle system in an innovative eye drop formulation. J Pharm Sci. 2010;99(10):4317-4325.
8. Junghanns JU, Müller RH. Nanocrystal technology, drug delivery and clinical applications. Int J Nanomedicine. 2008;3(3):295-309.
9. Zhang XX, Eden HS, Chen X. Peptides in cancer nanomedicine: drug carriers, targeting ligands and protease substrates. J Control Release. 2012;159(1):2-13.
10. Crielaard BJ, Lammers T, Schiffelers RM, Storm G. Drug targeting systems for inflammatory disease: one for all, all for one. J Control Release. 2012;161(2):225-234.
11. Hafner A, Lovrí J, Voinovich D, Filipovi-Grić J. Melatonin-loaded lecithin/chitosan nanoparticles: physicochemical characterisation and permeability through Caco-2 cell monolayers. Int J Pharm. 2009;381(2): 205-213.
12. Pavelí Z, Škalko-Basnet N, Filipovi-Gřić J, Martinac A, JalšenjakI. Development and in vitro evaluation of a liposomal vaginal delivery system for acyclovir. J Control Release. 2005; 106(1-2):34-43.
13. Pepí I, Lovrí J, Filipovi-Gřić J. How do polymeric micelles cross epithelial barriers? Eur J Pharm Sci. 2013;50(1):42-55.
14. Hafner A, Lovrí J, Pepí I, Filipovi-Gřić J. Lecithin/chitosan nano- particles for transdermal delivery of melatonin. J Microencapsul. 2011;28(8):807-815.
15. Lammers T, Kiessling F, Hennink WE, Storm G. Drug targeting to tumors: principles, pitfalls and (pre-) clinical progress. J Control Release. 2012;161(2):175-187.
16. Petros RA, DeSimone JM. Strategies in the design of nanoparticles for therapeutic applications. Nat Rev Drug Discov. 2010;9(8):615-627.
17. Duncan R, Gaspar R. Nanomedicine(s) under the microscope. Mol Pharm. 2011;8(6):2101-2141.
18. Filipovi-Gřić J, Mrhar A, Junginger H. Thematic Issue on Emerging nanopharmaceuticals for non-parenteral application routes. Eur J Pharm Sci. 2013;50(1):1.
19. European Commission/ETP Nanomedicine. Roadmaps in Nanomedicine Towards 2020: Joint European Commission/ETP Nanomedicine expert report. European Commission/ETP Nanomedicine; 2009. Available from: http://www.etp-nanomedicine.eu/public/press-documents/ publications/etpnpublications/091022_ETPN_Report_2009.pdf. Accessed December 17, 2013.
20. Svenson S. Clinical translation of nanomedicines. Curr Opin Solid State Mater Sci. 2012;16(6):287-294.
21. Barenholz Y. Doxil®-the first FDA-approved nano-drug: lessons learned. J Control Release. 2012;160(2):117-134.
22. Jabir NR, Tabrez S, Ashraf GM, Shakil S, Damanhouri GA, Kamal MA. Nanotechnology-based approaches in anticancer research. Int J Nanomedicine. 2012;7:4391-4408.
23. Chang HI, Yeh MK. Clinical development of liposome-based drugs: formulation, characterization, and therapeutic efficacy. Int J Nanomedicine. 2012;7:49-60.
24. Torchilin VP. Recent advances with liposomes as pharmaceutical carriers. Nat Rev Drug Discov. 2005;4(2):145-160.
25. Davis ME, Chen ZG, Shin DM. Nanoparticle therapeutics: an emerging treatment modality for cancer. Nat Rev Drug Discov. 2008;7(9): 771-782.
26. Hofheinz RD, Gnad-Vogt SU, Beyer U, Hochhaus A. Liposomal encapsulated anti-cancer drugs. Anticancer Drugs. 2005;16(7): 691-707.
27. Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer. 2003;97(11):2869-2879.
28. Rahman AM, Yusuf SW, Ewer MS. Anthracycline-induced cardiotoxicity and the cardiac-sparing effect of liposomal formulation. Int J Nano-medicine. 2007;2(4):567-583.
29. Fukui H, Koike T, Nakagawa T, et al. Comparison of LNS-AmB, a novel low-dose formulation of amphotericin B with lipid nano-sphere (LNS), with commercial lipid-based formulations. Int J Pharm. 2003;267(1-2):101-112.
30. Hamill RJ. Amphotericin B formulations: a comparative review of efficacy and toxicity. Drugs. 2013;73(9):919-934.
31. Angst MS, Drover DR. Pharmacology of drugs formulated with {Eth}epoFoam: a sustained release drug delivery system for parenteral administration using multivesicular liposome technology. Clin Pharmacokinet. 2006;45(12):1153-1176.
32. Senior JH. Medical applications of multivesicular lipid-based particles: DepoFoam™ encapsulated drugs. In: Lasic DD, Papahadjopoulos D, editors. Medical Applications of Liposomes. Amsterdam, The Netherlands: Elsevier; 1998:733-750.
33. Frampton JE. Mifamurtide: a review of its use in the treatment of osteosarcoma. Paediatr Drugs. 2010;12(3):141-153.
34. Chen H, Khemtong C, Yang X, Chang X, Gao J. Nanonization strate- gies for poorly water-soluble drugs. Drug Discov Today. 2011;16(7-8): 354-360.
35. Keck CM, Müller RH. Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation. Eur J Pharm Biopharm. 2006;62(1):3-16.
36. Xia D, Cui F, Piao H, et al. Effect of crystal size on the in vitro dissolution and oral absorption of nitrendipine in rats. Pharm Res. 2010;27(9): 1965-1976.
37. Desai PR, Date AA, Patravale VB. Overcoming poor oral bioavailability using nanoparticle formulations - opportunities and limitations. Drug Discov Today Technol. 2012;9(2):e87-e95.
38. Lu Y, Park K. Polymeric micelles and alternative nanonized delivery vehicles for poorly soluble drugs. Int J Pharm. 2013;453:198-214.
39. Tziomalos K, Athyros VG. Fenofibrate: a novel formulation (Triglide) in the treatment of lipid disorders: a review. Int J Nanomedicine. 2006;1(2):129-147.
40. Florence AT, Attwood D. Physicochemical Principles of Pharmacy. Fourth edition ed: Pharmaceutical Press, London, UK; 2006. p.22.
41. Bawa R. Nanoparticle-based therapeutics in humans: a survey. Nanotechnol Law Bus. 2008;5(2):137-155.
42. Shegokar R, Müller RH. Nanocrystals: industrially feasible multifunctional formulation technology for poorly soluble actives. Int J Pharm. 2010;399(1-2):129-139.
43. Brough C, Williams RO 3rd. Amorphous solid dispersions and nano-crystal technologies for poorly water-soluble drug delivery. Int J Pharm. 2013;453(1):157-166.
44. Ling H, Luoma JT, Hilleman D. A review of currently avail-able fenofibrate and fenofibric acid formulations. Cardiol Res. 2013;4(2):47-55.
45. Yoo JW, Irvine DJ, Discher DE, Mitragotri S. Bio-inspired, bioengineered and biomimetic drug delivery carriers. Nat Rev Drug Discov. 2011;10(7):521-535.
46. Usonis V, Bakasenas V, Valentelis R, Katiliene G, Vidzeniene D, Herzog C. Antibody titres after primary and booster vaccination of infants and young children with a virosomal hepatitis A vaccine (Epaxal). Vaccine. 2003;21(31):4588-4592.
47. Bovier PA. Epaxal: a virosomal vaccine to prevent hepatitis A infection. Expert Rev Vaccines. 2008;7(8):1141-1150.
48. Herzog C, Hartmann K, Kunzi V, et al. Eleven years of Inflexal V-a viro-somal adjuvanted influenza vaccine. Vaccine. 2009;27(33): 4381-4387.
49. Duncan R. Polymer therapeutics as nanomedicines: new perspectives. Curr Opin Biotechnol. 2011;22(4):492-501.
50. Gaspar R, Duncan R. Polymeric carriers: preclinical safety and the regulatory implications for design and development of polymer thera-peutics. Adv Drug Deliv Rev. 2009;61(13):1220-1231.
51. Poelstra K, Prakash J, Beljaars L. Drug targeting to the diseased liver. J Control Release. 2012;161(2):188-197.
52. Draca N, Lazic R, Simic P, Dumic-Cule I, Luetic AT, Gabric N. Potential beneficial role of sevelamer hydrochloride in diabetic retinopathy. Med Hypotheses. 2013;80(4):431-435.
53. Narang AS, Delmarre D, Gao D. Stable drug encapsulation in micelles and microemulsions. Int J Pharm. 2007;345(1-2):9-25.
54. Lawrence MJ, Rees GD. Microemulsion-based media as novel drug delivery systems. Adv Drug Deliv Rev. 2000;45(1):89-121.
55. Miele E, Spinelli GP, Miele E, Tomao F, Tomao S. Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer. Int J Nanomedicine. 2009;4:99-105.
56. Stirland DL, Nichols JW, Miura S, Bae YH. Mind the gap: a survey of how cancer drug carriers are susceptible to the gap between research and practice. J Control Release. 2013;172(3):1045-1064.
57. Jahn MR, Andreasen HB, Futterer S, et al. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011;78(3):480-491.
58. Borchard G, Fluhmann B, Muhlebach S. Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regul Toxicol Pharmacol. 2012;64(2): 324-328.
59. Zager RA, Johnson AC, Hanson SY, Wasse H. Parenteral iron formulations: a comparative toxicologic analysis and mechanisms of cell injury. Am J Kidney Dis. 2002;40(1):90-103.
60. Yokoyama M. Clinical applications of polymeric micelle carrier systems in chemotherapy and image diagnosis of solid tumors. J Exp Clin Med. 2011;3(4):151-158.
61. sorrentotherapeutics.com [homepage on the Internet]. Cynviloq™ Available from: http://sorrentotherapeutics.com/cynviloq/. Accessed November 17, 2013.
62. European Medicines Agency/Committee for Medicinal Products for Human Use. Joint MHLW/EMA reflection Paper on the development of Block Copolymer Micelle Medicinal Products. London: European Medicines Agency; 2013. Available from: http://www.ema.europa. eu/docs/en_GB/document_library/Scientific_guideline/2013/02/ WC500138390.pdf. Accessed December 17, 2013.
63. Ehmann F, Sakai-Kato K, Duncan R, et al. Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines. Nanomedicine (Lond). 2013;8(5):849-856.
64. European Medicines Agency. Reflection Paper on the Data Requirements for Intravenous Liposomal Products Developed with Reference to an Innovator Liposomal Product. London: European Medicines Agency; 2013. Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2013/03/WC500140351.pdf. Accessed December 17, 2013.
65. European Medicines Agency. Reflection Paper on Non-Clinical Studies for Generic Nanoparticle Iron Medicinal Product Applications. London: European Medicines Agency; 2011. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/ WC500105048.pdf. Accessed December 17, 2013.
66. European Medicines Agency/Committee for Medicinal Products for Human Use. Reflection Paper on Nanotechnology-Based Medicinal Products for Human Use. London: European Medicines Agency; 2006. Available from: http://www.ema.europa.eu/docs/en_GB/document_ library/Regulatory_and_procedural_guideline/2010/01/WC500069728. pdf. Accessed December 17, 2013.
67. Kettiger H, Schipanski A, Wick P, Huwyler J. Engineered nanoma-terial uptake and tissue distribution: from cell to organism. Int J Nanomedicine. 2013;8:3255-3269.
68. Vamvakas S, Martinalbo J, Pita R, Isaac M. On the edge of new technologies (advanced therapies, nanomedicines). Drug Discov Today Technol. 2011;8(1):e1-e42.
69. Maynard AD. Don't define nanomaterials. Nature. 2011;475(7354):31.
70. Nystrom AM, Fadeel B. Safety assessment of nanomaterials: implications for nanomedicine. J Control Release. 2012;161(2):403-408.
71. Hamburg MA. Science and regulation. FDA's approach to regulation of products of nanotechnology. Science. 2012;336(6079):299-300.
72. fda.gov [homepage on the Internet]. FDA's approach to regulation of nanotechnology products. Silver Spring, MD: US Food and Drug Admin- istration; 2012. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm301114.htm. Accessed November 17, 2013.
73. fda.gov [homepage on the Internet]. Considering whether an FDA-regulated product involves the application of nanotechnology: guidance for industry. Silver Spring, MD: US Food and Drug Administration; 2011. Available from: http://www.fda.gov/RegulatoryInformation/ Guidances/ucm257698.htm. Accessed November 17, 2013.
74. European Commission. VOLUME 2A, Procedures for Marketing Authorization. Chapter 4, centralised procedure. London: European Medicines Agency; 2006. Available from: http://ec.europa.eu/health/ files/eudralex/vol-2/a/chap4rev200604_en.pdf. Accessed December 17, 2013.
75. fda.gov [homepage on the Internet]. Frequently asked questions about the FDA drug approval process. Silver Spring, MD: US Food and Drug Administration; 2011. Available from: http://www.fda.gov/ Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm. Accessed November 17, 2013.
76. Gabellieri C, Frima H. Nanomedicine in the European Commission policy for nanotechnology. Nanomedicine. 2011;7(5):519-520.
77. Frima HJ, Gabellieri C, Nilsson MI. Drug delivery research in the European Union's Seventh Framework Programme for Research. J Control Release. 2012;161(2):409-415.
78. Gandjour A, Chernyak N. A new prize system for drug innovation. Health Policy. 2011;102(2-3):170-177.
79. Pautler M, Brenner S. Nanomedicine: promises and challenges for the future of public health. Int J Nanomedicine. 2010;5:803-809.
80. BCC Research [homepage on the Internet]. Nanotechnology in medical applications: the global market. Wellesley, MA: BCC Research LLC; 2010. Available from: http://www.bccresearch.com/market-research/ healthcare/nanotechnology-medical-applications-hlc069a.html. Accessed August 20, 2013.
81. ETP Nanomedicine. NANOMEDICINE 2020 Contribution of Nanomedicine to Horizon 2020: White paper to the Horizon 2020 Framework Programme for Research and Innovation - recommendations from the nanomedicine community. ETP Nanomedicine; 2013. Available from: http://www.etp-nanomedicine.eu/public/press-documents/ publications/etpn-publications/etpn-white-paper-H2020. Accessed December 17, 2013.
82. http://www.etp-nanomedicine.eu. [homepage on the Internet]. Accessed 17 November 2013.
83. Golan O, Hansen P, Kaplan G, Tal O. Health technology prioritization: which criteria for prioritizing new technologies and what are their relative weights? Health Policy. 2011;102(2-3):126-135.
84. Velasco Garrido M, Gerhardus A, Rottingen JA, Busse R. Developing health technology assessment to address health care system needs. Health Policy. 2010;94(3):196-202.
85. Kolasa K, Schubert S, Manca A, Hermanowski T. A review of Health Technology Assessment (HTA) recommendations for drug therapies issued between 2007 and 2009 and their impact on policy making processes in Poland. Health Policy. 2011;102(2-3):145-151.
86. Ozieranski P, McKee M, King L. The politics of health technology assessment in Poland. Health Policy. 2012;108(2-3):178-193.
87. Perleth M, Busse R, Schwartz FW. Regulation of health-related t{stroke}echnologies in Germany. Health Policy. 1999;46(2):105-126.
88. Wild C, Langer T. Emerging health technologies: informing and supporting health policy early. Health Policy. 2008;87(2):160-171.
89. Maynard AD, Aitken RJ, Butz T, etal. Safe handling of nanotechnology. Nature. 2006;444(7117):267-269.
90. Pepí I, Lovrí J, Cetinǎizmek B, Reichl S, Filipovi-Gřić J. Toward the practical implementation of eye-related bioavailability prediction models. Drug Discov Today. 2014;19(1):31-44.