A safety and tolerability study of differently-charged nanoparticles for local pulmonary drug delivery

Toxicology and Applied Pharmacology

Volumn 246, Issue 1-2, 2010, Pages 83-90

  Harush Frenkel, Oshrat ^a   Bivas Benita, Maytal ^b   Nassar, Taher ^a   Springer, Chaim ^c   Sherman, Yoav ^c   Avital, Avraham ^c   Altschuler, Yoram ^d   Borlak, Jurgen ^e   Benita, Simon ^a  

^a HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^b HARVARD MEDICAL SCHOOL   (United States)

^c HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^d HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^e FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

Author keywords

Anionic; Cationic; Nanoparticles; PEG PLA; Pulmonary; Safety; Surface charge; Tolerability

Indexed keywords

DRUG CARRIER; HEMOGLOBIN; MACROGOL; NANOPARTICLE; OCTADECYLAMINE; POLYLACTIC ACID; POLYSORBATE 80;

ANIMAL EUTHANASIA; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BIOCHEMISTRY; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; FEMALE; HEMATOLOGICAL PARAMETERS; HISTOPATHOLOGY; HUMAN; HUMAN CELL; LEUKOCYTE COUNT; LUNG LAVAGE; LUNG TOXICITY; LYMPHOCYTE COUNT; MACROPHAGE; MEAN CORPUSCULAR HEMOGLOBIN; MEAN CORPUSCULAR VOLUME; MOUSE; NONHUMAN; PARTICLE SIZE; SAFETY; SURFACE CHARGE; THROMBOCYTE COUNT; WEIGHT GAIN; ZETA POTENTIAL;

ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; BRONCHOALVEOLAR LAVAGE FLUID; CELL LINE, TUMOR; CELLS, CULTURED; DRUG DELIVERY SYSTEMS; FEMALE; HUMANS; INTUBATION, INTRATRACHEAL; LUNG; LYMPHOCYTE COUNT; MICE; MICE, INBRED BALB C; NANOPARTICLES; POLYETHYLENE GLYCOLS;

MUS;

EID: 77953695336     PISSN: 0041008X     EISSN: 10960333     Source Type: Journal    
DOI: 10.1016/j.taap.2010.04.011     Document Type: Article

References (45)

1. Asgharian B., Kelly J.T., Tewksbury E.W. Respiratory deposition and inhalability of monodisperse aerosols in Long-Evans rats. Toxicol. Sci. 2003, 71:104-111.
2. Azarmi S., Roa W.H., Lobenberg R. Targeted delivery of nanoparticles for the treatment of lung diseases. Adv. Drug Deliv. Rev. 2008, 60:863-875.
3. Bivas-Benita M., Zwier R., Junginger H.E., Borchard G. Non-invasive pulmonary aerosol delivery in mice by the endotracheal route. Eur. J. Pharm. Biopharm. 2005, 61:214-218.
4. Borm P.J., Kreyling W. Toxicological hazards of inhaled nanoparticles-potential implications for drug delivery. J. Nanosci. Nanotechnol. 2004, 4:521-531.
5. Cook R.O., Pannu R.K., Kellaway I.W. Novel sustained release microspheres for pulmonary drug delivery. J. Control. Release 2005, 104:79-90.
6. Courrier H.M., Butz N., Vandamme T.F. Pulmonary drug delivery systems: recent developments and prospects. Crit. Rev. Ther. Drug Carrier Syst. 2002, 19:425-498.
7. Dailey L.A., Wittmar M., Kissel T. The role of branched polyesters and their modifications in the development of modern drug delivery vehicles. J. Control. Release 2005, 101:137-149.
8. Dailey L.A., Jekel N., Fink L., Gessler T., Schmehl T., Wittmar M., Kissel T., Seeger W. Investigation of the proinflammatory potential of biodegradable nanoparticle drug delivery systems in the lung. Toxicol. Appl. Pharmacol. 2006, 215:100-108.
9. Devalapally H., Shenoy D., Little S., Langer R., Amiji M. Poly(ethylene oxide)-modified poly(beta-amino ester) nanoparticles as a pH-sensitive system for tumor-targeted delivery of hydrophobic drugs: part 3. Therapeutic efficacy and safety studies in ovarian cancer xenograft model. Cancer Chem. Pharmacol. 2007, 59:477-484.
10. Dong Y., Feng S.S. Poly(d,l-lactide-co-glycolide)/montmorillonite nanoparticles for oral delivery of anticancer drugs. Biomaterials 2005, 26:6068-6076.
11. Fessi H., Puisieux F., Devissaguet J.-P., Ammoury N., Benita S. Nanocapsule formation by interfacial polymer deposition following solvent displacement. Int. J. Pharm. 1989, 55:R1-R4.
12. Fischer D., Li Y., Ahlemeyer B., Krieglstein J., Kissel T. In vitro cytotoxicity testing of polycations: influence of polymer structure on cell viability and hemolysis. Biomaterials 2003, 24:1121-1131.
13. Fu J., Fiegel J., Krauland E., Hanes J. New polymeric carriers for controlled drug delivery following inhalation or injection. Biomaterials 2002, 23:4425-4433.
14. Geys J., Nemmar A., Verbeken E., Smolders E., Ratoi M., Hoylaerts M.F., Nemery B., Hoet P.H. Acute toxicity and prothrombotic effects of quantum dots: impact of surface charge. Environ. Health Perspect. 2008, 116:1607-1613.
15. Golde W.T., Gollobin P., Rodriguez L.L. A rapid, simple, and humane method for submandibular bleeding of mice using a lancet. Lab. Anim. 2005, 34:39-43.
16. Harush-Frenkel O., Debotton N., Benita S., Altschuler Y. Targeting of nanoparticles to the clathrin-mediated endocytic pathway. Biochem. Biophys. Res. Commun. 2007, 353:26-32.
17. Harush-Frenkel O., Rozentur E., Benita S., Altschuler Y. Surface charge of nanoparticles determines their endocytic and transcytotic pathway in polarized MDCK cells. Biomacromolecules 2008, 9:435-443.
18. Huang Y.C., Vieira A., Yeh M.K., Chiang C.H. Pulmonary anti-inflammatory effects of chitosan microparticles containing betamethasone. J. Bioact. Compatible Polym. 2007, 22:30-41.
19. Kemp S.J., Thorley A.J., Gorelik J., Seckl M.J., O'Hare M.J., Arcaro A., Korchev Y., Goldstraw P., Tetley T.D. Immortalization of human alveolar epithelial cells to investigate nanoparticle uptake. Am. J. Respir. Cell Mol. Biol. 2008, 39:591-597.
20. Kuo Y.C., Lin C.W. Impact of arginine-modified solid lipid nanoparticles on the membrane charge of human brain-microvascular endothelial cells. Colloids Surf. 2009, 72:201-207.
21. Lai S.K., O'Hanlon D.E., Harrold S., Man S.T., Wang Y.Y., Cone R., Hanes J. Rapid transport of large polymeric nanoparticles in fresh undiluted human mucus. Proc. Natl. Acad. Sci. U.S.A. 2007, 104:1482-1487.
22. Lai S.K., Wang Y.Y., Hanes J. Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues. Adv. Drug Del. Rev. 2009, 61:158-171.
23. Longest P.W., Xi J.X. Effectiveness of direct Lagrangian tracking models for simulating nanoparticle deposition in the upper airways. Aerosol Sci. Technol. 2007, 41:380-397.
24. Medina C., Santos-Martinez M.J., Radomski A., Corrigan O.I., Radomski M.W. Nanoparticles: pharmacological and toxicological significance. Br. J. Pharmacol. 2007, 150:552-558.
25. Merkel O.M., Beyerle A., Librizzi D., Pfestroff A., Behr T.M., Sproat B., Barth P.J., Kissel T. Nonviral siRNA delivery to the lung: investigation of PEG-PEI polyplexes and their in vivo performance. Mol. Phars. 2009, 6:1246-1260.
26. Mo Y., Lim L.Y. Paclitaxel-loaded PLGA nanoparticles: potentiation of anticancer activity by surface conjugation with wheat germ agglutinin. J. Control. Release 2005, 108:244-262.
27. Mosmann T. Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays. J. Immunol. Methods 1983, 65:55-63.
28. Musumeci T., Ventura C.A., Giannone I., Ruozi B., Montenegro L., Pignatello R., Puglisi G. PLA/PLGA nanoparticles for sustained release of docetaxel. Int. J. Pharm. 2006, 325:172-179.
29. Natarajan A., Gruettner C., Ivkov R., DeNardo G.L., Mirick G., Yuan A., Foreman A., DeNardo S.J. Nanoferrite particle based radioimmunonanoparticles: binding affinity and in vivo pharmacokinetics. Bioconj. Chem. 2008, 19:1211-1218.
30. Nel A., Xia T., Madler L., Li N. Toxic potential of materials at the nanolevel. Science N.Y. 2006, 311:622-627.
31. Nemmar A., Hoylaerts M.F., Hoet H.M., Vermylen J., Benoit N. Size effect of intratracheally instilled particles on pulmonary inflammation and vascular thrombosis. Toxicol. Appl. Pharmacol. 2003, 186:38-45.
32. Nguyen J., Steele T.W., Merkel O., Reul R., Kissel T. Fast degrading polyesters as siRNA nano-carriers for pulmonary gene therapy. J. Control. Release 2008, 132:243-251.
33. Nguyen J., Reul R., Betz T., Dayyoub E., Schmehl T., Gessler T., Bakowsky U., Seeger W., Kissel T. Nanocomposites of lung surfactant and biodegradable cationic nanoparticles improve transfection efficiency to lung cells. J. Control. Release 2009, 140(1):47-54.
34. Oberdorster G., Maynard A., Donaldson K., Castranova V., Fitzpatrick J., Ausman K., Carter J., Karn B., Kreyling W., Lai D., Olin S., Monteiro-Riviere N., Warheit D., Yang H. Principles for characterizing the potential human health effects from exposure to nanomaterials: elements of a screening strategy. Part Fibre Toxicol. 2005, 2:8.
35. Orr G., Panther D.J., Phillips J.L., Tarasevich B.J., Dohnalkova A., Hu D., Teeguarden J.G., Pounds J.G. Submicrometer and nanoscale inorganic particles exploit the actin machinery to be propelled along microvilli-like structures into alveolar cells. ACS Nano 2007, 1:463-475.
36. Packhaeuser C.B., Lahnstein K., Sitterberg J., Schmehl T., Gessler T., Bakowsky U., Seeger W., Kissel T. Stabilization of aerosolizable nano-carriers by freeze-drying. Pharm. Res. 2009, 26:129-138.
37. Peetla C., Rao K.S., Labhasetwar V. Relevance of biophysical interactions of nanoparticles with a model membrane in predicting cellular uptake: study with TAT peptide-conjugated nanoparticles. Mol. Pharm. 2009, 6:1311-1320.
38. Perumal O.P., Inapagolla R., Kannan S., Kannan R.M. The effect of surface functionality on cellular trafficking of dendrimers. Biomaterials 2008, 29:3469-3476.
39. Rogueda P.G., Traini D. The nanoscale in pulmonary delivery. Part 1: deposition, fate, toxicology and effects. Expert Opin. Drug Deliv. 2007, 4:595-606.
40. Rytting E., Nguyen J., Wang X., Kissel T. Biodegradable polymeric nanocarriers for pulmonary drug delivery. Expert Opin. Drug Deliv. 2008, 5:629-639.
41. Segel M.J., Aqeilan R., Zilka K., Lorberboum-Galski H., Wallach-Dayan S.B., Conner M.W., Christensen T.G., Breuer R. Effect of IL-2-Bax, a novel interleukin-2-receptor-targeted chimeric protein, on bleomycin lung injury. Int. J. Exp. Pathol. 2005, 86:279-288.
42. Springer C., Benita S., Sherman Y., Gursoy N., Gilhar D., Avital A. Poly-lactic-glycolic acid microspheres: a biodegradable marker for the diagnosis of aspiration in hamsters. Pediatr. Res. 2005, 58:537-541.
43. Stasko N.A., Johnson C.B., Schoenfisch M.H., Johnson T.A., Holmuhamedov E.L. Cytotoxicity of polypropylenimine dendrimer conjugates on cultured endothelial cells. Biomacromolecules 2007, 8:3853-3859.
44. Stuart D., Benberg R., Ku T., Azarmi S., Ely L., Roa W., Prenner E.J. Biophysical investigation of nanoparticle interactions with lung surfactant model systems. J. Biomed. Nanotechnol. 2006, 2:245-252.
45. Tetley T.D. Health effects of nanomaterials. Biochem. Soc. Trans. 2007, 35:527-531.