Bezpieczeństwo nanoproduktów leczniczych: nowe obszary badań toksykologicznych

• Autorzy: Grudzinski I.P.

Warianty tytułu

EN

Safety of medicinal nanoproducts: new areas of toxicological research

• Języki publikacji: PL

Abstrakty

PL

Wiele innowacyjnych produktów leczniczych będących przedmiotem projektów rozwojowych zawiera w swoim składzie substancje czynne zbudowane z nanocząstek. Badania dowodzą, że właściwości fizykochemiczne i biologiczne materiałów ulegają istotnym zmianom w miarę zmniejszania wielkości do wymiarów „nano”, tak więc zwiększające się wykorzystanie nanomateriałów w produktach leczniczych wymaga przyjęcia właściwej strategii w procesie szacowania ryzyka dla zdrowia człowieka. W artykule przedyskutowano paradygmat badań toksykologicznych stosowanych w celu oceny bezpieczeństwa przedklinicznego nanoproduktów leczniczych. Zaprezentowano również nowe kierunki i wyzwania w zakresie badań nanotoksykologicznych.

EN

Many current innovative medicinal products under research and development comprise active substances composing of nanoparticles as fundamental building blocks. Studies show that physicochemical and biological properties of materials can alter dramatically at nanoscopic scale, and therefore, the growing use of nanomaterials in medicinal products requires the application of suitable strategies in human health risk assessment processes. In this article, the paradigm of toxicology studies to assess the preclinical safety of medicinal nanoproducts is discussed. New goals and challenges in the field of nanotoxicological researches are also elucidated.

Słowa kluczowe

PL

nanomaterialy; nanomedycyna; nanotoksykologia; bezpieczenstwo stosowania lekow; nanoczastki; ryzyko zdrowotne; zdrowie czlowieka

• Wydawca: -
• Czasopismo: Roczniki Państwowego Zakładu Higieny
• Rocznik: 2011
• Tom: 62
• Numer: 3
• Opis fizyczny: s.239-246,fot.,bibliogr.

Twórcy

autor

Grudzinski I.P.

• Katedra i Zakład Toksykologii, Wydział Farmaceutyczny, Warszawski Uniwersytet Medyczny, ul.Banacha 1, 02-097 Warszawa

Bibliografia

• 1. Aillon KL., Xie Y., El-Gendy N., Berkland CJ., Forrest ML.: Effects of nanomaterial physicochemical properties on in vivo toxicity. Adv. Drug Delivery Reviews 2009, 61, 457-466.
• 2. Auffan M., Decome L., Rose J., Orsiere T., De Meo M., Briois V., Chaneac C., Olivi L., Berge-Lefranc JL., Botta A., Wiesner M., Bottero J.: In vitro interactions between DMSA-coated maghemite nanoparticles and human fibroblasts: A Physicochemical and cyto-genotoxical study. Environ. Sci. Technol. 2006, 40, 4367-4373.
• 3. Bawarski WE., Chidlowsky E., Bharali DJ., Mousa SA.: Emerging nanopharmaceuticals. Nanotechnology, Biology, and Medicine 2008, 4, 273-282.
• 4. Bethan Hughes.: Industry concern over EU hepatotoxicity guidance. Nature Review. Drug Discovery 2008, 7, 719.
• 5. Boone B., Meyer M., Cusick C., Ennulat D., Provencher Bolliger A., Everds A., Meador V., Elliott G., Honor G., Bounous D., Jordan H.: Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies. Vet. Clin. Pathol. 2005, 34, 182-188.
• 6. Chan VS.: Nanomedicine: An unresolved regulatory issue. Reg. Toxicol. Pharmacol. 2006, 46, 218-224.
• 7. Cho S., Cho M., Jeong J., Choi M., Cho HY., Han BS., Kim SH., Kim HO., Lim Y., Chung BH., Jeong J.: Acute toxicity and pharmacokinetics of 13 nm-sized PEG-coated gold nanoparticles. Toxicol. Appl. Pharmacol. 2009, 236, 16-24.
• 8. Crosera M., Bovenzi M., Maina M., Adami G., Zanette C., Florio C., Larese FF.: Nanoparticle dermal absorption and toxicity: a review of the literature. Int. Arch. Occup. Environ. Health 2009, 82, 1043-1055.
• 9. EMA.: Reflection paper on nanotechnology-based medicinal products for human use. EMEA/CHMP/79769/2006. London, 29 June 2006.
• 10. EMA.: Reflection paper on non-clinical evaluation of drug-induced liver injury (DILI). 2010, June, EMEA/ CHMP/SWP/150115/2006, 1-12.
• 11. Figuerola A., Corato R., Manna L., Pellegrino T.: From iron oxide nanoparticles towards advanced iron-based inorganic materials designed for biomedical applications. Pharmacol. Res. 2010, 62, 126-143.
• 12. Firme C., Prabhakar M., Bandaru R.: Toxicity issues in the application of carbon nanotubes to biological systems. Nanomedicine: Nanotechnology, Biology, and Medicine 2010, 6, 245-256.
• 13. Fischer HC, Chan W.: Nanotoxicity: the growing need for in vivo study. Current Opinion in Biotechnology 2007, 18, 565-571.
• 14. Grainger DA.: Nanotoxicity assessment: all small talk? Adv. Drug Delivery Reviews 2009, 61, 419-421.
• 15. Hagens WJ., Oomen AG., Jong WH., Cassee FL., Sips A.: What do we (need to) know about the kinetic properties of nanoparticles in the body? Reg. Toxicol. Pharmacol. 2007, 49, 217-229.
• 16. Hallock MR., Greenley P., DiBerardinis L., Kallin D.: Potential risks of nanomaterials and how to safely handle materials of uncertain toxicity. J. Chem. Health Safety 2009, 2, 16-23.
• 17. Hu YL., Gao JQ.: Potential neurotoxicity of nanoparticles. Int. J. Pharm. 2010, 394, 115-121.
• 18. Hurt R., Monthioux M., Kane A.: Toxicology of carbon nanomaterials: Status, trends, and perspectives on the special issue. Carbon 2006, 44, 1028-1033.
• 19. Hussain SM., Hess KL., Gearhart JM., Geiss KT., Schlager JT.: In vitro toxicity of nanoparticles in BRL 3A rat liver cells. Toxicology in vitro 2005, 19, 975-983.
• 20. Jaganathan J., Ivanisevic A.: In vitro cytotoxic evaluation of metallic and magnetic DNA-templated nanostructures. Appl. Mat. Interface. 2010, 2, 1407-1413.
• 21. Jain K., Kesharwani P, Gupta U, Jain NK.: Dendrimer toxicity: Let’s meet the challenge. Int. J. Pharm. 2010, 394, 122-142.
• 22. Jan E, Byrne S, Cuddihy M, Davies AM, Volkov Y, Gun Y, Kotov NA.: High-content screening as a universal tool for fingerprinting of cytotoxicity of nanoparticles. ACS NANO 2008, 2, 928-938.
• 23. Johnston HJ, Semmler-Behnke M, Brown DW, Kreyling W, Tran L, Stone V.: Evaluating the uptake and intracellular fate of polystyrene nanoparticles by primary and hepatocyte cell lines in vitro. Toxicol. Appl. Pharmacol. 2010, 242, 66-78.
• 24. Jones CF, Grainger DW.: In vitro assessments of nanomaterial toxicity. Adv. Drug Delivery Reviews 2009, 61, 438-456.
• 25. Kagan VE, Bayir H, Shvedova AA.: Nanomedicine and nanotoxicology - two sides of the same coin. Nanomedicine: Nanotechnology, Biology, and Medicine 2005, 1, 313- 316.
• 26. Kahru A, Dubourguier HC.: From ecotoxicology to nanoecotoxicology. Toxicology 2010, 269, 105-119.
• 27. Kahru A, Savolainen K.: Potential hazard of nanoparticles: From properties to biological and environmental effects. Toxicology 2010, 269, 89-91.
• 28. Lacerda L, Bianco A, Prato M, Kostarelos K.: Carbon nanotubes as nanomedicines: From toxicology to pharmacology. Adv. Drug Delivery Reviews 2006, 58, 1460- 1470.
• 29. Lehr CM.: Biological barriers and nanomedicine – Timely challenges in advanced drug delivery research. Eur. J. Pharm. Biopharm. 2009, 72, 287-288.
• 30. Lei R, Wu C, Yang B, Ma H, Shi S, Wang Q, Wang Q, Yuan Y, Liao M.: Integrated metabolomic analysis of the nano-sized copper particle-induced hepatotoxicity and nephrotoxicity in rats: A rapid in vivo screening method for nanotoxicity. Toxicol. App. Pharmacol. 2008, 232, 292-301.
• 31. Li S, Huang L.: Pharmacokinetics and biodistribution of nanoparticles. Mol. Pharmac. 2008, 5, 496-504.
• 32. Linkov I, Satterstrom FK, Corey LM.: Nanotoxicology and nanomedicine: making hard decisions. Nanomedicine: Nanotechnology, Biology, and Medicine 2008, 4, 167-171.
• 33. Magrez A, Kasas K, Salicio S, Pasquier N, Seo J, Celio M, Catsicas S, Schwaller B, Forro L.: Cellular toxicity of carbon-based nanomaterials. Nano Lett. 2006, 6, 1121- 1125.
• 34. Matthieu JP.: Nanoparticles - Aspects of safety and risk management. J. Verbr. Lebensm. 2008, 3, 308- 311.
• 35. Maynard AD.: Nanotechnology: assessing the risks. Nanotoday 2006, 1, 22-33.
• 36. McBurnay R, Hines W, Tunglen N, Schanckenberg L, Berger R, Moland C, Han T, Fuscoe J, Chang C, Chen J, Su Z, FanX, Tong Z, Booth S, Balasubramanian R, Courchense PL, Cambell J, Graber A, Guo Y, Juhasz P, Li T, Lynch MD, Morel N, Plasterer T, Takach EJ, Zeng T, Takach E, Zeng H, Belang F.: The liver txicity biomarker study: Phase I design and preliminary results. Toxicologic Pathology 2009, 37, 52-64, 2009.
• 37. Meng H, Xia T, George S, Nel A.: A predictive toxicological paradigm for the safety assessment of nanomaterials. ACS Nano 2009, 3, 1620-1627.
• 38. Morose G.: The 5 principles of ‘‘Design for safer nanotechnology”. J. Clear Prod. 2010, 18, 285-289.
• 39. Mutlu G, Budinger GR, Green AA, Urich D, Soberanes S, Chiarella SE, Alheid GF, McCrimmon DR, Szleifer I, Hersam MC.: Biocompatible nanoscale dispersion of single-walled carbon nanotubes minimizes in vivo pulmonary toxicity. Nano Lett. 2010, 10, 1664-1670.
• 40. Neil Kaplowitz.: Idiosyncratic drug hepatotoxicity. Nature Rev. Drug 2005, 4, 489-499.
• 41. Nishimori H, Kondoh M, Isoda I, Tsunoda I, Tsutsumi Y, Yagi K.: Silica nanoparticles as hepatotoxicants. Eur. J. Pharm. Biopharm. 2009, 72, 496-501.
• 42. Ostrowski AD, Martin T, Conti J, Hurt I, Harthon BH.: Nanotoxicology: characterizing the scientific literature, 2000-2007. J. Nanopart. Res. 2009, 11, 251-257.
• 43. Park B, Martin P.: Nanotechnology: applying the 3Rs to risk assessment. NC3RS 2009, 17, 1-11.
• 44. Pelley JL, Daar AS, Saner MA.: State of academic knowledge on toxicity and biological fate of quantum dots. Toxicol. Sci. 2009, 112, 276-296.
• 45. Pohjala L, Hakkola J, Vuorela P.: Predictive value of cellular methods in toxicological evaluation of lead candidates: an insight to hepatotoxicity. Drug Discovery Today: Technologies. 2007, 4, 98-101.
• 46. Royal Society & the Royal Academy of Engineering.: Nanoscience and nanotechnologies: Opportunities and uncertainties. London: Royal Society. UK, 2004.
• 47. Savolainen K, Alenius H, Norppa H, Pylkkänen L, Tuomi T, Kasper G.: Risk assessment of engineered nanomaterials and nanotechnologies - A review. Toxicology 2010, 269, 92-104.
• 48. Savolainen K, Pylkkanen L, Norppa H, Falck G, Lindberg H, Tuomi T, Vippola M, Alenius H, Hämeri K, Koivisto J, Brouwer D, Mark D, Bard D, Berges M, Jankowska E, Posniak M, Farmer P Singh R, Krombach F, Bihari P, Kasper G, Seipenbusch M.: Nanotechnologies, engineered nanomaterials and occupational health and safety - A review. Safety Science 2010, 48, 957-963.
• 49. Seaton A.: Nanotoxicology: Hazard and risk. NanoBiotechnology 2005, 3, 1551-1294.
• 50. Shrader-Frechette K.: Nanotoxicology and ethical conditions for informed consent. Nanoethics 2007, 1, 47-56.
• 51. Shubayev VI, Pisanic TR, Jin S.: Magnetic nanoparticles for theragnostics. Adv. Drug Delivery Reviews 2009, 61, 467-477.
• 52. Snopczyński T, Góralczyk K, Czaja K, Struciński P, Hernik A, Korcz W, Ludwicki JK.: Nanotechnologia – możliwości i zagrożenia. Roczn. PZH 2009, 60, 101-111.
• 53. Suh WH, Suslick KS, Stucky GD, Suh YH.: Nanotechnology, nanotoxicology, and neuroscience. Prog. Neurobiol. 2009, 87, 133-170.
• 54. Vega-Villa KR, Takemoto JK, Yáñez JA, Remsberg CM, Forrest ML, Davies NM.: Clinical toxicities of nanocarrier systems. Adv. Drug Delivery Reviews 2008, 60, 929-938.
• 55. Wang B, Feng W, Wang TH, Jia G, Wang W, Shi JW, Zhang F, Zhao YL, Chai ZF.: Acute toxicity of nano- and micro-scale zinc powder in healthy adult mice. Toxicol. Lett. 2006, 161, 115-123.
• 56. Xie G, Sun G, Zhong G, Shi L, Zhang D.: Biodistribution and toxicity of intravenously administered silica nanoparticles in mice. Arch. Toxicol. 2010, 84, 183-190.
• 57. Yuan Y, Chen Y, Liu J, Wang H, Liu Y.: Biodistribution and fate of nanodiamonds in vivo. Diamond Related Materials 2009, 18, 95-100.
• 58. Yun Y, Eteshola E, Bhattacharya A, Dong Z, Shim J, Conforti L, Kim D, Schulz M, Ahn Ch, Watts W.: Tiny medicine - nanomaterial-based biosensors. Sensors 2009, 9, 9275-9299.
• 59. Zhang Y, Bai Y, Yan B.: Functionalized carbon nanotubes for potential medicinal applications. Drug Discovery Today 2010, 15, 428-435.