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The Impact of Nanopharmaceuticals on Healthcare and Regulation

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Nanomedicine

Part of the book series: Nanostructure Science and Technology ((NST))

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Abstract

The integration of nanotechnology into medical field has given birth to some new interdisciplinary areas of nanomedicine including nanopharmaceuticals, which covers discovery, development, and delivery of drug. With the unique and advanced properties offered by nanomaterials, the drug delivery systems and other therapeutic methods have been improved with great significance, providing efficient solutions toward various clinical conundrums, and shifting the paradigm of health care system with remarkable enhancement. On the other hand, with existing regulatory systems becoming incompetent for the new generations of medicinal products, a capable and unified regulatory system specifically towards these nanopharmaceutical products is urged. Meanwhile, the sustained and more extensive research and investigation on nanotoxicity is required to further support and guild the establishment of new/refined regulations as well as further development of nanopharmaceuticals. Nonetheless, nanopharmaceuticals holds great potential to form the mainstream of pharmaceutical industry in the future.

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References

  1. Rivera Gil P, Hühn D, del Mercato LL et al (2010) Nanopharmacy: inorganic nanoscale devices as vectors and active compounds. Pharmacol Res 62(2):115–125

    Article  CAS  Google Scholar 

  2. Zhang X, Xu X, Bertrand N et al (2012) Interactions of nanomaterials and biological systems: implications to personalized nanomedicine. Adv Drug Deliv Rev 64(13):1363–1384

    Article  CAS  Google Scholar 

  3. Bawarski WE, Chidlowsky E, Bharali DJ et al (2008) Emerging nanopharmaceuticals. Nanomed Nanotechnol Biol Med 4(4):273–282

    Article  CAS  Google Scholar 

  4. Bhargavi C, Anil DB, Praneta Desale K (2013) Nanotherapeutics – an era of drug delivery system in nanoscience. Indian J Res Pharm Biotechnol 1(2):210–214

    Google Scholar 

  5. Steinbach OC (2013) Industry update: the latest developments in therapeutic delivery. Ther Deliv 4(1):17–20

    Article  CAS  Google Scholar 

  6. Eaton MAW (2011) How do we develop nanopharmaceuticals under open innovation? Nanomed Nanotechnol Biol Med 7(4):371–375

    Article  Google Scholar 

  7. Gaspar R (2007) Regulatory issues surrounding nanomedicines: setting the scene for the next generation of nanopharmaceuticals. Nanomedicine 2(2):143–147

    Article  CAS  Google Scholar 

  8. Moghimi SM, Peer D, Langer R (2011) Reshaping the future of nanopharmaceuticals: ad iudicium. ACS Nano 5(11):8454–8458

    Article  CAS  Google Scholar 

  9. Duncan R, Gaspar R (2011) Nanomedicine(s) under the microscope. Mol Pharm 8(6):2101–2141

    Article  CAS  Google Scholar 

  10. Duncan R (2011) Polymer therapeutics as nanomedicines: new perspectives. Curr Opin Biotechnol 22(4):492–501

    Article  CAS  Google Scholar 

  11. Mansour HM, Park C, Bawa R (2014) Design and development of approved nanopharmaceutical products. In: Bawa R, Audette GF, Rubinstein I (eds) Handbook of clinical nanomedicine: from bench to bedside, 1st edn. Pan Stanford Publishing/Taylor & Francis, Singapore, pp 1–27

    Google Scholar 

  12. Hossain Saad MZ, Jahan R, Bagul U (2012) Nanopharmaceuticals: a new perspective of drug delivery system. Asian J Biomed Pharm Sci 2(14):11–20

    Google Scholar 

  13. Syed S, Zubair A, Frieri M (2013) Immune response to nanomaterials: implications for medicine and literature review. Curr Allergy Asthma Rep 13(1):50–57. http://www.ncbi.nlm.nih.gov/pubmed/22941559

  14. Yu MK, Park J, Jon S (2012) Magnetic nanoparticles and their applications in image-guided drug delivery. Drug Deliv Transl Res 2(1):3–21

    Article  CAS  Google Scholar 

  15. Farrell D, Ptak K, Panaro NJ et al (2011) Nanotechnology-based cancer therapeutics – promise and challenge – lessons learned through the NCI alliance for nanotechnology in cancer. Pharmacol Res 28(2):273–278

    Article  CAS  Google Scholar 

  16. Filippov SK, Chytil P, Konarev PV et al (2012) Macromolecular HPMA-based nanoparticles with cholesterol for solid-tumor targeting: detailed study of the inner structure of a highly efficient drug delivery system. Biomacromolecules 13(8):2594–2604

    Article  CAS  Google Scholar 

  17. Ismail MF, Elmeshad AN, Salem NA (2013) Potential therapeutic effect of nanobased formulation of rivastigmine on rat model of Alzheimer’s disease. Int J Nanomed 8:393–406

    Article  Google Scholar 

  18. Krol S, Ellis-Behnke R, Marchetti P (2012) Nanomedicine for treatment of diabetes in an aging population: state-of-the-art and future developments. Nanomed Nanotechnol Biol Med 8:S69–S76

    Article  CAS  Google Scholar 

  19. Shah RB, & Mansoor AK (2009) “Nanopharmaceuticals: Challenges and regulatory perspective.” In Nanotechnology in Drug Delivery, (pp. 621–646). Springer New York. http://link.springer.com/chapter/10.1007/978-0-387-77668-2_21

  20. Kolosnjaj J, Henri S, & Fathi M (2007) Toxicity studies of carbon nanotubes.” In Bio-Applications of Nanoparticles, (pp. 181–204). Springer New York. http://www.ncbi.nlm.nih.gov/pubmed/18217344

  21. Domingo C, Saurina J (2012) An overview of the analytical characterization of nanostructured drug delivery systems: towards green and sustainable pharmaceuticals: a review. Anal Chim Acta 744:8–22http://www.fda.gov/regulatoryinformation/guidances/ucm257698.htm#points. http://www.ncbi.nlm.nih.gov/pubmed/22935368

  22. Bawa R (2013) FDA and nanotech: baby steps lead to regulatory uncertainty. In: Bagchi D, Bagchi M, Moriyama H, Shahidi F (eds) Bio-nanotechnology: a revolution in food, biomedical and health sciences, 1st edn. Wiley, Oxford, pp 720–732

    Google Scholar 

  23. Bawa R (2011) Regulating nanomedicine – can the FDA handle it? Curr Drug Deliv 8(3):227–234

    Article  CAS  Google Scholar 

  24. FDA (2014) Considering whether an FDA-regulated product involves the application of nanotechnology. Available http://www.fda.gov/regulatoryinformation/guidances/ucm257698.htm#points. Accessed 18 July 2014

  25. Matrix Insight Ltd (2014) Request for services in the context of the FC ENTR/2008/006, lot 3: a Study to support the impact assessment of relevant regulatory options for nanomaterials in the framework of REACH. Available http://ec.europa.eu/DocsRoom/documents/5826/attachments/1/translations/en/renditions/native. Accessed 18 July 2014

  26. Bhogal N (2009) Regulatory and scientific barriers to the safety evaluation of medical nanotechnologies. Nanomedicine 4(5):495–498

    Article  Google Scholar 

  27. Wang R, Billone PS, Mullett WM (2013) Nanomedicine in action: an overview of cancer nanomedicine on the market and in clinical trials. J Nanomater. Article ID:629681

    Google Scholar 

  28. Dorbeck-Jung BR, Chowdhury N (2011) Is the European medical products authorisation regulation equipped to cope with the challenges of nanomedicines? Law Policy 33(2):276–303. http://doc.utwente.nl/78741/

  29. Manchun S, Dass CR, Sriamornsak P (2012) Targeted therapy for cancer using pH-responsive nanocarrier systems. Life Sci 90(11–12):381–387. http://www.ncbi.nlm.nih.gov/pubmed/22326503

  30. Vadlapudi AD, Mitra AK (2013) Nanomicelles: an emerging platform for drug delivery to the eye. Ther Deliv 4(1):1–3. http://www.ncbi.nlm.nih.gov/pubmed/23323774

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Correspondence to Yi Ge .

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Fan, R.Z., Fei, D., D’Aurelio, R., Ge, Y. (2014). The Impact of Nanopharmaceuticals on Healthcare and Regulation. In: Ge, Y., Li, S., Wang, S., Moore, R. (eds) Nanomedicine. Nanostructure Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-2140-5_17

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