Issues and concerns in nanotech product development and its commercialization

Journal of Controlled Release

Volumn 193, Issue , 2014, Pages 51-62

  Kaur, Indu Pal ^a   Kakkar, Vandita ^a   Deol, Parneet Kaur ^a   Yadav, Monika ^a   Singh, Mandeep ^a   Sharma, Ikksheta ^a  

^a PANJAB UNIVERSITY   (India)

Author keywords

Challenges; Marketed products; Nanoscale drug delivery systems; Pharmaceutical industry; USFDA

Indexed keywords

ACCIDENT PREVENTION; BIOCHEMISTRY; COMMERCE; CONTROLLED DRUG DELIVERY; NANOTECHNOLOGY; TARGETED DRUG DELIVERY;

CHALLENGES; DRUG DELIVERY SYSTEM; MARKETED PRODUCTS; PHARMACEUTICAL INDUSTRY; USFDA;

DRUG PRODUCTS;

LIPOSOME; NANOCARRIER; POLYMER; DRUG;

ARTICLE; COMMERCIAL PHENOMENA; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG DOSAGE FORM; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; NANOTECHNOLOGY; PRODUCT DEVELOPMENT; QUALITY CONTROL; CHEMISTRY; ECONOMICS; FINANCIAL MANAGEMENT; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; PATENT; SAFETY; TECHNOLOGY; TRENDS;

DRUG DELIVERY SYSTEMS; DRUG INDUSTRY; FINANCING, GOVERNMENT; FINANCING, ORGANIZED; INTELLECTUAL PROPERTY; NANOTECHNOLOGY; PHARMACEUTICAL PREPARATIONS; SAFETY; TECHNOLOGY TRANSFER;

EID: 84908268914     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2014.06.005     Document Type: Article

References (85)

1. http://www.nano.gov/nanotech-101/what/definition (Accessed on 1 March 2014)
2. OECD Working Party on Nanotechnology (WPN): Vision Statement 2010 http://www.oecd.org/sti/nano/oecdworkingpartyonnanotechnologywpnvisionstatement.htm 2010 (Accessed on 28 February 2014)
3. C. Palmberg The transfer and commercialisation of nanotechnology: a comparative analysis of university and company researches J. Technol. Transf. 33 2008 631 652
4. L. Mazzola Commercializing nanotechnology Nat. Biotechnol. 21 2003 1137 1143
5. http://www.nanotechproject.org/inventories/ (Accessed on 2 March 2014)
6. www.luxresearchinc.com (Accessed on 27 February 2014)
7. How can a big state like Texas become a leader in development of small products? Introduction small is becoming big business https://www.google.co.in/#q=NovaCentrix:+Growing+an+Ultratiny+Company (Accessed on 2 March 2014)
8. Market Opportunities in Nanotechnology Drug Delivery 2012 Cientifica Ltd 1 19
9. T. Flynn, and C. Wei The pathway to commercialization for nanomedicine Nanomedicine: NBM 1 2005 47 51
10. R.A. Stein Nanotechnology: is the magic bullet becoming reality? Insight and Intelligence 2014
11. M. Taylor Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? 2006 Wilson Center and The Pew Charitable Trusts Washington
12. The National Nanotechnology Initiative supplements to the president's 2014 budget 2013 1 88
13. A. Reamer, L. Icerman, and J. Youtie Technology Transfer and Commercialization: Their Role in Economic Development 2003 U.S. Department of Commerce
14. Technology Commercialization The Handbook of Technology Transfer 2005 Pacific Center for Technology Transfer Asia
15. T. Spinverse Commercialisation of Nanotechnology - Key Challenges Workshop Organised by Nanoforum in Helsinki, Finland 2007 1 27
16. R. Allen Venture capital investment in nanotechnology http://www.jonesday.com/practiceperspectives/nanotechnology/venturecapital.html (Accessed on 2 March 2014)
17. J. Bradley Nanotech venture capital: healthcare and life sciences provide life support https://portal.luxresearchinc.com/research/documentexcerpt/5891 2009 (Accessed on 4 March 2014)
18. T. Satterfield, M. Kandlikar, C. Beaudrie, J. Conti, and B. Harthorn Anticipating the perceived risk of nanotechnologies Nat. Nanotechnol. 4 2009 752 758
19. V. Morigi, A. Tocchio, C. Pellegrini, J. Sakamoto, M. Arnone, and E. Tasciotti Nanotechnology in medicine: from inception to market domination J. Drug Deliv. 2012 1 7
20. USFDA www.fda.gov/safety 2003 (Accessed on 20 March 2014)
21. K. Vega-Villa, J. Takemoto, J. Yanez, C. Remsberg, M. Forrest, and N. Davies Clinical toxicities of nanocarrier systems Adv. Drug Deliv. Rev. 60 2008 929 938
22. R. Bosetti, and L. Vereeck Future of nanomedicine obstacles and remedies Nanomedicine 6 2011 747 755
23. S. Suppan Racing Ahead U.S. Agri-Nanotechnology in the Absence of Regulation 2011 Institute for Agriculture and Trade Policy 3 20
24. A.M. Hahn, A.K. Singh, P. Sharma, C.B. Scott, and M.M. Brij Nanoparticles as contrast agents for in-vivo bioimaging: current status and future perspectives Anal. Bioanal. Chem. 399 2011 3 27
25. E. AltInoʇlu, T.J. Russin, J.M. Kaiser, B.M. Barth, P.C. Eklund, M. Kester, and J.H. Adair Near-infrared emitting fluorophore-doped calcium phosphate nanoparticles for invivo imaging of human breast cancer ACS Nano 2 2008 2075 2084
26. W. Soutter Nanotechnology in Cosmetics vol. 2014 2012
27. K. Donaldson, P.H. Beswick, and P.S. Gilmour Free radical activity associated with the surface of particles: a unifying factor in determining biological activity? Toxicol. Lett. 88 1-3 1996 293 298
28. C. Lherm, R.H. Müller, F. Puisieux, and P. Couvreur Alkylcyanoacrylate drug carriers. II. Cytotoxicity of In vitro uptake of polystyrene latex cyanoacrylate nanoparticles with different alkyl chain length Int. J. Pharm. 84 1992 13 22
29. S. Raj, S. Jose, U.S. Sumod, and M. Sabitha Nanotechnology in cosmetics: opportunities and challenges J. Pharm. Bioallied Sci. 4 3 2012 186 193
30. Small Wonder? Nanotechnology and Cosmetics vol. 2014 2008
31. Safety Fears Over Nanocosmetics vol. 2014 2008 BBC News
32. Nanoparticles Found in 10 Top Brand Cosmetics vol. 2014 2009 Friends of the Earth Australia
33. Nanotech Widespread in Cosmetics, Report Finds vol. 2014 2009 The Sydney Morning Herald
34. US FDA Nanotechnology: a report of the U.S. Food and Drug Administration Nanotechnology Task Force, 23 July 2007 available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108954.htm (Accessed on 24 February 2014)
35. A. Kumari, S.K. Yadav, and S.C. Yadav Biodegradable polymeric nanoparticles based drug delivery systems Colloids Surf. B 75 2010 1 18
36. J. Mehta, J. Blake, and C. Craddock Comparative efficacy of amphotericin B lipid complex and liposomal amphotericin B for the treatment of invasive fungal infections in HSCT recipients and other immunocompromised patient populations with hematologic malignancies: a critical review Open Transplant. J. 5 2011 23 29
37. A.C. Silva, M.L. Garcia, M.A. Egea, J. Fonseca, and R. Silva Preparation, characterization and biocompatibility studies on risperidone-loaded solid lipid nanoparticles (SLN): high pressure homogenization versus ultrasound Colloids Surf. B: Biointerfaces 86 2011 158 165
38. R.H. Muller, S. Runge, K. Schulze-Forster, and W. Mehnert Cytotoxicity of solid lipid nanoparticles as a function of the lipid matrix and the surfactant Pharm. Res. 4 1997 458 462
39. M. Nassimi, H.D. Lauenstein, R. Hussein, H.G. Hoymann, and W. Koch A toxicological evaluation of inhaled solid lipid nanoparticles used as a potential drug delivery system for the lung Eur. J. Pharm. Biopharm. 75 2010 107 116
40. Consumer products inventory The Project on Emerging Nanotechnologies 2014 (http://www.nanotechproject.org/cpi/. Accessed on 1 March 2014)
41. J. Pardeike, A. Hommoss, and R.H. Muller Lipid nanoparticles (SLN, NLC) in cosmetic and pharmaceutical dermal products Int. J. Pharm. 366 2009 170 184
42. M. Ferrari Nanogeometry: beyond drug delivery Nat. Nanotechnol. 3 2008 131 132
43. Y. Barenholz Doxil® - The first FDA approved nanodrug: lessons learned J. Control. Release 160 2012 117 134
44. J.H. Sakamoto, A.L. van de Ven, B. Godin, E. Blanco, R.E. Serda, A. Grattoni, A. Ziemys, A. Bouamrani, T. Hu, S.I. Ranganathan, E. De Rosa, J.O. Martinez, C.A. Smid, R.M. Buchanan, S.Y. Lee, S. Srinivasan, M. Landry, A. Meyn, E. Tasciotti, X. Liu, P. Decuzzi, and M. Ferrari Enabling individualized therapy through nanotechnology Pharmacol. Res. 62 2010 57 89
45. F.L. Muller, and J.M. Latimer Anticipation of scale up issues in pharmaceutical development Comput. Chem. Eng. 33 2009 1051 1055
46. A. Laouini, C. Jaafar-Maalej, I. Limayem-Blouza, S. Sfar, C. Charcosset, and H. Fessi Preparation, characterization and applications of liposomes: state of the art J. Colloid Sci. Biotechnol. 1 2012 147 168
47. N. Desai Challenges in development of nanoparticle-based therapeutics AAPS J. 14 2012 282 295
48. I. Kaur, S. Kakkar, M. Yadav, K. Jindal, and I. Sharma Autoclavable nanovesicular composition IPA/700/Del/2014 2014 (Filed on 11 March 2014)
49. R. Shegokar, K.K. Singh, and R.H. Müller Production & stability of stavudine solid lipid nanoparticles - From lab to industrial scale Int. J. Pharm. 416 2011 461 470
50. R. Shegokar, K.K. Singh, and R.H. Mueller Nevirapine nanosuspension: comparative investigation of production methods Nanotechnol. Dev. 1 2011 e4
51. V. Kakkar, and I.P. Kaur Preparation, characterization and scale-up of sesamol loaded solid lipid nanoparticles Nanotechnol. Dev. 2 2012 40 45
52. A.P. Ranjan, A. Mukerjee, L. Helson, and J.K. Vishwanatha Scale up, optimization and stability analysis of Curcumin C3 complex-loaded nanoparticles for cancer therapy J. Nanobiotechnol. 10 2012 38
53. R.H. Muller, K. Mader, and S. Gohla Solid lipid nanoparticles (SLN) for controlled drug delivery - A review of the state of the art Eur. J. Pharm. Biopharm. 50 2000 161 177
54. S.A. Galindo-Rodriguez, F. Puel, S. Briancon, E. Allemann, E. Doelker, and H. Fessi Comparative scale-up of three methods for producing ibuprofen-loaded nanoparticles Eur. J. Pharm. Sci. 25 2005 357 367
55. M.M. Mojahedian, S. Daneshamouz, S.M. Samani, and A. Zargaran A novel method to produce solid lipid nanoparticles using n-butanol as an additional co-surfactant according to the o/w microemulsion quenching technique Chem. Phys. Lipids 174 2013 32 38
56. M. Gaumet, A. Vargas, R. Gurny, and F. Delie Nanoparticles for drug delivery: the need for precision in reporting particle size parameters Eur. J. Pharm. Biopharm. 69 2008 1 9
57. K. Langer, M.G. Anhorn, I. Steinhauser, S. Dreis, D. Celebi, N. Schrickel, S. Faust, and V. Vogel Human serum albumin (HSA) nanoparticles: reproducibility of preparation process and kinetics of enzymatic degradation Int. J. Pharm. 347 1-2 2008 109 117
58. W. Mehnert, and K. Mader Solid lipid nanoparticles: production, characterization and applications Adv. Drug Deliv. Rev. 47 2001 165 196
59. A. Saez, M. Guzman, J. Molpeceres, and M.R. Aberturas Freeze-drying of polycaprolactone and poly(D, L-lactic-glycolic) nanoparticles induce minor particle size changes affecting the oral pharmacokinetics of loaded drugs Eur. J. Pharm. Biopharm. 50 2000 379 387
60. P. Fonte, S. Soares, A. Costa, J.C. Andrade, V. Seabra, S. Reis, and B. Sarmento Effect of cryoprotectants on the porosity and stability of insulin-loaded PLGA nanoparticles after freeze-drying Biomatter 2 2013 329 339
61. C.L. Ventola The nanomedicine revolution Part 3. Regulatory and safety challenges Pharm. Ther. 37 2012 632 639
62. L. Zhang, F.X. Gu, J.M. Chan, A.Z. Wang, R.S. Langer, and O.C. Farokhzad Nanoparticles in medicine: therapeutic applications and developments Clin. Pharmacol. Ther. 83 5 2008 761 769
63. R. Duncan, and R. Gaspar Nanomedicine(s) under the microscope Mol. Pharm. 8 6 2011 2101 2141
64. G. Heimeriks Interdisciplinarity in biotechnology, genomics and nanotechnology Sci. Public Policy 40 2013 97 112
65. D. Mowery Nanotechnology and the US national innovation system: continuity and change J. Technol. Transf. 36 2011 697 711
66. L. Kantor NIH roadmap for medical research Alcohol Res. Health 31 2008 12 13
67. R. Bawa Special report: patents and nanomedicine Nanomedicine 2 2007 351 374
68. R. Bawa Patenting inventions in bionanotechnology - A primer for scientists and lawyers D.E. Reisner, Bionanotechnology: Global Prospects 2009 CRC Press Boca Raton FL 309 337
69. FDA Guidance for Industry Safety of Nanomaterials in Cosmetic Products 2012 1 24
70. R. Bawa Nanopharmaceuticals eujnm 3 2010 34 39
71. H.M. Mansour, C.W. Park, and R. Bawa Design and development of approved nanopharmaceutical products R. Bawa, G. Audette, I. Rubinstein, Handbook of clinical nanomedicine-from bench to beadside remedies vol. 1 2014 Pan Stanford publishing/CRC press Singapore
72. R. Bawa FDA and nanotech: baby steps lead to regulatory uncertainty D. Bagchi, Bionanotechnology: A Revolution in Biomedical Sciences and Human Health 2013 Wiley Blackwell UK 720 732
73. R. Bawa Regulating nanomedicine - can the FDA handle it? Curr. Drug Deliv. 8 2011 227 234
74. C. Rados Nanotechnology: the size of things to come FDA consumer Nov-Dec 2005 40 42
75. G. Mendel Nanotechnology governance Albany Law Rev. 59 2008 1323 1329
76. M. Hamburg FDA's approach to regulation of products of nanotechnology Science 336 2012 299 300
77. US FDA Nanotechnology Regulatory Science Research Plan http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm273325.htm 2013 (Accessed on 1 March 2014)
78. V. Wagner, A. Dullaart, A. Bock, and A. Zweck The emerging nanomedicine landscape Nat. Biotechnol. 24 2006 1211 1217
79. R. Bawa, S. Melethil, W. Simmons, and D. Harris Nanopharmaceuticals - patenting issues and FDA regulatory challenges Am. Bar Assoc. Sci. Technol. Lawyer 5 2008 10 15
80. D. Kahan, D. Braman, P. Slovic, J. Gastil, and G. Cohen Cultural cognition of the risks and benefits of nanotechnology Nat. Nanotechnol. 4 2009 87 91
81. http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp (Accessed on 2 march 2014)
82. NANOCOM http://www.nanocom-eu.org/NanoCom/Homepage.html 2012 (Accessed on 18 February 2014)
83. NanoMed Round Table Communication Working Group www.nanomedroundtable.org/system/files/private/WP6%20CommunicationAnnex1.pdf (Accessed on 20 February 2014)
84. J. Paradise Claiming nanotechnology: improving USPTO efforts at classification of emerging nano-enabled pharmaceutical technologies Northwest. J. Technol. Intellect. Prop. 10 2012 171 189
85. H. Stormer Capital Report on Nanotechnology 2002 Lux Research New York