Toxicological assessment of orally delivered nanoparticulate insulin

Nanotoxicology

Volumn 2, Issue 4, 2008, Pages 205-217

  Reis, Catarina P ^a   Figueiredo, Isabel V ^a   Carvalho, Rui A ^b   Jones, John ^c   Nunes, Patricia ^b,c   Soares, Ana F ^a,b   Silva, Cristina F ^d   Ribeiro, Antonio J ^a   Veiga, Francisco J ^a   Damgé, Christiane ^e   Cabrita, António M S ^f   Neufeld, Ronald J ^g  

^a UNIVERSITY OF COIMBRA   (Portugal)

^b UNIVERSITY OF COIMBRA   (Portugal)

^c UNIVERSITY OF COIMBRA   (Portugal)

^d Labesfal Grupo Fresenius Kabi   (Portugal)

^e UNIVERSITÉ DE STRASBOURG   (France)

^f UNIVERSITY OF COIMBRA   (Portugal)

^g QUEEN S UNIVERSITY   (Canada)

Author keywords

Insulin; Nanoencapsulation; Nanoparticles; Oral delivery; Toxicology

Indexed keywords

CREATININE; INSULIN; NANOPARTICLE; UREA;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DRUG DELIVERY SYSTEM; GLUCOSURIA; KIDNEY FUNCTION; LIVER FUNCTION; MALE; NONHUMAN; PRIORITY JOURNAL; RAT;

ANIMALIA; RATTUS;

EID: 57349099275     PISSN: 17435390     EISSN: 17435404     Source Type: Journal    
DOI: 10.1080/17435390802398309     Document Type: Article

References (55)

1. Akbarzadeh A, Noruzian D, Jamshidi S, Farhangi A, Mehrabi MR, B. Lame Rad, Mofidian M, Allahverdi A. 2007. Treatment of streptozotocin induced diabetes in male rats by immunoisolated transplantation of islet cells. Ind J Clin Biochem 22:71-76.
2. Al-Achi A, Greenwood R. 2001. A brief report on some physiological parameters of streptozotocin-diabetic rat. Drug Dev Ind Pharm 27:465-468.
3. Barbas J. 1997. Nefropatia diabética. In: Duarte R, editor. Diabetologia Clínica. Lisboa: Lidel-Edições Técnicas, Lda. pp 255-269.
4. Cancercare. 2007. Toronto, Canada: Cancer Care Ontario; 2007 June 5; Available from the website: http://www.cancercare.on.ca/pdfdrugs/STREPTOZ.pdf
5. CaparrozAssef SM, Grespan R, Batista RCF, BersaniAmado FA, Baroni S, Dantas JA, Cuman RKN, Bersani-Amado CA. 2005. Toxicity studies of Cordia salicifolia extract. Acta Sci Health Sci 27:4141-4144.
6. Cui F, Zhang L, Zheng J, Kawashima Y. 2004. A study of insulin-chitosan complex nanoparticles used for oral administration. J Drug Del Sci Tech 14:435-439.
7. Damgé C, Reis CP, Maincent P. 2008. Nanoparticle strategies for the oral delivery of insulin. Expert Opin. Drug Deliv 5:45-68.
8. Damgé C, Maincent P, Ubrich N. 2007. Oral delivery of insulin associated to polymeric nanoparticles in diabetic rats. J Control Rel 117:163-170.
9. Damgé C, Michel C, Aprahamian M, Couvreur P. 1988. New approach for oral administration of insulin with polyalkylcyanoacrylate nanocapsules as drug carrier. Diabetes 37:246-251.
10. Delie F, Blanco-Príeto MJ. 2005. Polymeric particulates to improve oral bioavailability of peptide drugs. Molecules 10:65-80.
11. des Rieux A, Fievez V, Garinot M, Schneider Y-J, Preat V. 2006. Nanoparticles as potential oral delivery systems of proteins and vaccines: A mechanistic approach. J Control Rel 116:1-27.
12. Duarte R. 1997. Insulina. In: Duarte R, editor. Diabetologia Clínica. Lisboa: Lidel-Edições Técnicas, Lda. pp 139-151.
13. Duarte R, Zeller PV, Lisboa PE. 1997. Alterações oculares na Diabetes. In: Duarte R, editor. Diabetologia Clínica. Lisboa: Lidel-Edições Técnicas, Lda. pp 242-254.
14. Fazzari P, Penachioni J, Gianola S, Rossi F, Eickholt BJ, Maina F, Alexopoulou L, Sottile A, Comoglio PM, Flavell RA, et al. 2007. Plexin-B1 plays a redundant role during mouse development and in tumour angiogenesis. BMC Dev Biol 7:55.
15. FDA. 2007. Guidance for Industry, Q3C-Tables and List. FDA. 2007 July 5; Available from the website: http://www.fda.gov/ohrms/dockets/98fr/01b-0431- gdl0001.doc
16. Fernandez-Urrusuno R, Fatal E, Porquet D, Feger J, Couvreur P. 1995. Evaluation of liver toxicological effects induced by polyalkylcyanoacrylate nanoparticles. Toxicol Appl Pharmacol 130:272-279.
17. Florence AT. 2005. Nanoparticle uptake by the oral route: Fulfilling its potential? Drug Discovery Today: Technologies 2:75-81.
18. Florence AT, Hillery AM, Hussain N, Jani PU. 1995. Nanoparticles as carriers for oral peptide absorption: Studies on particle uptake and fate. J Control Rel 36:39-46.
19. Gabbay K. 1975. Hyperglycemia, polyol metabolism, and complication of diabetes mellitus. Ann Rev Med 26:521-536.
20. Gaspar R. 2007. Regulatory issues surrounding nanomedicines: Setting the scene for the next generation of nanopharmaceuticals. Future Nanomed 2:143-147.
21. Hamet P, Sugimoto H, Umeda F, Franks DJ. 1983. Platelets and vascular smooth muscle: abnormalities of phosphodiesterase, aggregation, and cell growth in experimental and human diabetes. Metabolism 32:124-130.
22. Healthbanks. 2007. Blood urea nitrogen. Healthbanks. 2007 July 5; Available from the website: http://www.healthbanks.com/PatientPortal/Public/ LinkPublic.do?ArticleID=HW5aa36271
23. Inal S, Yilmaz N, Nisbet C, Guvenc T, Samsun T. 2006. Biochemical and histopathological findings of N-butyl-2-cyanoacrylate in oral surgery: An experimental study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 102:e14-17.
24. Jacobson-Kram D, McGovern T. 2007. Toxicological overview of impurities in pharmaceutical products. Adv Drug Del Rev 59:38-42.
25. Jung T, Kamm W, Breitenbach A, Kaiserling E, Xiao JX, Kissel T. 2000. Biodegradable nanoparticles for oral delivery of peptides: Is there a role for polymers to affect mucosal uptake? Eur J Pharm Biopharm 50:147-160.
26. Kabanov AV. 2006. Polymer genomics: An insight into pharmacology and toxicology of nanomedicines. Adv Drug Del Rev Supplementary Non-Thematic Collection 58:1597-1621.
27. Karakilcik AZ, Hayat A, Aydilek N, Zerin M, Cay M. 2005. Effects of vitamin C on liver enzymes and biochemical parameters in rats anesthetized with halothane. Gen Physiol Biophys 24:47-55.
28. Kim JS, Yoon T-J, Yu KN, Kim BG, Park SJ, Kim HW, Lee KH, Park SB, Lee J-K, Cho MH. 2006. Toxicity and tissue distribution of magnetic nanoparticles in mice. Toxicol Sci 89:338-347.
29. Kreuter J. 1991. Peroral administration of nanoparticles. Adv Drug Deliv Rev 7:71-86.
30. Kume E, Aruga C, Ishizuka Y, Takahashi K, Miwa S, Itoh M, Fujimura H, Toriumi W, Kitamura K, Doi K. 2005. Gene expression profiling in streptozotocin treated mouse liver using DNA microarray. Exp Toxicol Pathol 56:235-244.
31. Lerco MM, Spadella CT, Machado JLM, Schellini SA, Pavodini CR. 2003. Caracterização de um modelo experimental de Diabetes Mellitus, induzido pela aloxana em ratos. Estudo clínico e laboratorial. Acta Cirúrg. Bras 18:136-142.
32. Lopes HJJ. 2007. Enzimas no laboratório clínico. Aplicações diagnósticas. 2007 July 2; Available from the website: www.goldanalisa.com.br/publicacoes/Enzimas_no_Laboratorio_Clinico.pdf,
33. Ma Z, Lim TM, Lim L-Y. 2005. Pharmacological activity of peroral chitosan-insulin nanoparticles in diabetic rats. Int J Pharm 293:271-280.
34. Martin FJ, Miguez JM, Aldegunde M, Atienza G. 1995. Platelet serotonin transport is altered in streptozotocin-induced diabetic rats. Life Sci 56:1807-1815.
35. medicina.fm.usp.br. 2007. São Paulo, Brasil; Faculdade de Medicina da Universidade de São Paulo; 2007 June 18; Available from the website: http://medicina.fm.usp.br/endoresidentes/roteiro/diabetes_mellitus_roteiro.pdf.
36. Morinelli TA, Tempel GE, Jaffa AA, Silva RH, Naka M, Folger W, Halushka PV. 1993. Thromboxane A2/prostaglandin H2 receptors in streptozotocin-induced diabetes: Effects of insulin therapy in the rat. Prostaglandins 45:427-438.
37. Nanopharmaceuticals. 2007. NanoPharmaceuticals.org; Available from the website: http://www.nanopharmaceuticals.org/Polymeric_nanoparticles.html
38. Oppenheim RC, Stewart NF, Gordon L, Patel HM. 1982. Production and evaluation of orally administered insulin nanoparticles. Drug Dev Ind Pharm 8:531-546.
39. Pan Y, Li Y, Zhao H, Zheng J, Xu H, Wei G, Hao J, Cui F. 2002. Bioadhesive polysaccharide in protein delivery system: Chitosan nanoparticles improve the intestinal absorption of insulin in vivo. Int J Pharm 249:139-147.
40. Priya CAYB, Anitha K, Mohan EM, Pillai KS, Murthy PB, Nadu T. 1997. Toxicity of fluoride to diabetic rats. Fluoride 30: 51-58.
41. Quintana XG, Rodríguez MN, Sabo AG. 2001. Las plaquetas en la diabetes mellitus. Rev Cub Hematol Inmunol Hemoter 17:19-24.
42. Reis C, Veiga F, Ribeiro A, Neufeld R, Damgé C. 2008. Nanoparticulate biopolymers deliver insulin orally eliciting pharmacological response. J Pharm Sci [ePub March 27, 2008] DOI: 10.1002/jps.21363.
43. Reis CP, Neufeld RJ, Ribeiro, Antonio J, Veiga F. 2006a. Nanoencapsulation I. Methods for preparation of drug-loaded polymeric nanoparticles. Nanomed: Nanotechnol, Biol Med 2:8-21.
44. Reis CP, Neufeld RJ, Ribeiro AJ, Veiga F. 2006b. Nanoencapsulation II. Biomedical applications and current status of peptide and protein nanoparticulate delivery systems. Nanomed: Nanotechnol, Biol Med 2:53-65.
45. Reis CP, Ribeiro AJ, Houng S, Veiga F, Neufeld RJ. 2007. Nanoparticulate delivery system for insulin: Design, characterization and in vitro/in vivo bioactivity. Eur J Pharm Sci 30:392-397.
46. Reis CP, Ribeiro AJ, Neufeld RJ, Veiga F. 2006c. Alginate microparticles as novel carrier for oral insulin delivery. Biotechnol Bioeng 96:977-989.
47. Sajeesh S, Sharma CP. 2006. Cyclodextrin-insulin complex encapsulated polymethacrylic acid based nanoparticles for oral insulin delivery. Int J Pharm 325:147-154.
48. Sayim F, Yavasoglu NUK, Uyanikgil Y, Aktug H, Yavasoglu A, Turgut M. 2005. Neurotoxic effects of cypermethrin in Wistar rats: A haematological, biochemical and histophathologic study. J Health Sci 51:300-307.
49. Tschöpe D, Schwippert B, Schettler B, Kiesel U, Rothe H, Roesen P, Gries FA. 1992. Increased GPIIB/IIIA expression and altered DNA-ploidy pattern in megakaryocytes of diabetic BB-rats. Eur J Clin Invest 22:591-598.
50. Umeda F, Adnot S, Franks DJ, Hamet P. 1982. Cyclic nucleotide phosphodiesterase and aggregation in platelets from diabetic rats. Metabolism 31:704-709.
51. Valentovic MA, Lubawy WC. 1983. Impact of insulin or tolbutamide treatment on 14C-arachidonic acid conversion to prostacyclin and/or thromboxane in lungs, aortas, and platelets of streptozotocin-induced diabetic rats. Diabetes 32:846-851.
52. Vauthier C, Dubernet C, Fattal E, Pinto-Alphandary H, Couvreur P. 2003. Poly(alkylcyanoacrylates) as biodegradable materials for biomedical applications. Adv Drug Deliv Rev 55:519-548.
53. Vega-Villa KR, Takemoto JK, Yáñez JA, Remsberg CM, Forrest ML, Davies NM. 2008. Clinical toxicities of nanocarrier systems. Adv Drug Deliv Rev 60:929-938.
54. Wijkstrom M, Kirchhof N, Graham M, Ingulli E, Colvin RB, Christians U, Hering BJ, Schuurman H-J. 2005. Cyclosporine toxicity in immunosuppressed streptozotocin-diabetic nonhuman primates. Toxicology 207:117-127.
55. Yngen M, Li N, Hjemdahl P, Wallen NH. 2001. Insulin enhances platelet activation in vitro. Thromb Res 104:85-91.