Salmon calcitonin-loaded Eudragit® and Eudragit®-PLGA nanoparticles: In vitro and in vivo evaluation

Journal of Microencapsulation

Volumn 29, Issue 2, 2012, Pages 156-166

  Cetin, Meltem ^a   Aktas, Mustafa Sinan ^a   Vural, Imran ^b   Ozturk, Murat ^a  

^a ATATÜRK UNIVERSITY   (Turkey)

^b HACETTEPE UNIVERSITY   (Turkey)

Author keywords

Eudragit L100; Eudragit RSPO; NaTDC; oral nanoparticles; PLGA; SCT

Indexed keywords

CALCITONIN; EUDRAGIT; NANOPARTICLE; POLYLACTIC ACID; POLYMER; TAURODEOXYCHOLIC ACID;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYPOCALCEMIA; IN VITRO STUDY; IN VIVO STUDY; NANOENCAPSULATION; NONHUMAN; PARTICLE SIZE; RAT; SALMON; SURFACE CHARGE;

ANIMALS; BONE DENSITY CONSERVATION AGENTS; CALCITONIN; CHEMISTRY, PHARMACEUTICAL; DRUG DELIVERY SYSTEMS; FEMALE; LACTIC ACID; NANOPARTICLES; PARTICLE SIZE; POLYGLYCOLIC ACID; POLYMETHACRYLIC ACIDS; RATS; RATS, SPRAGUE-DAWLEY;

EID: 84856923602     PISSN: 02652048     EISSN: 14645246     Source Type: Journal    
DOI: 10.3109/02652048.2011.635426     Document Type: Article

References (56)

1. Acharya G, Shin CS, Vedantham K, McDermott M, Rish T, Hansen K, Fu Y, Park K. A study of drug release from homogeneous PLGA microstructures. J Control Release, 2010;146(2):201-6.
2. Bilati U, Allémann E, Doelker E. Development of a nanoprecipitation method intended for the entrapment of hydrophilic drugs into nanoparticles. Eur J Pharm Sci, 2005;24(1):67-75.
3. Bowman K, Leong KW. Chitosan nanoparticles for oral drug and gene delivery. Int J Nanomed, 2006;1(2):117-28.
4. Catalioto RM, Triolo A, Giuliani S, Altamura M, Evangelista S, Maggi CA. Increased paracellular absorption by bile salts and P-glycoprotein stimulated efflux of otilonium bromide in Caco-2 cells monolayers as a model of intestinal barrier. J Pharm Sci, 2008;97(9):4087-100.
5. Cetin M, Aktas Y, Vural I, Capan Y, Dogan LA, Duman M, Dalkara T. Preparation and in vitro evaluation of bFGF-loaded chitosan nanoparticles. Drug Deliv, 2007;14(8):525-9.
6. Cetin M, Atila A, Kadioglu Y. Formulation and in vitro characterization of Eudragit® L100 and Eudragit® L100-PLGA nanoparticles containing diclofenac sodium. AAPS PharmSciTech, 2010;11(3):1250-6.
7. Cetin M, Youn YS, Capan Y, Lee KC. Preparation and characterization of salmon calcitonin-biotin conjugates. AAPS PharmSciTech, 2008;9(4):1191-7.
8. Cholewinski M, Lückel B, Horn H. Degradation pathways, analytical characterization and formulation strategies of a peptide and a protein. Calcitonine and human growth hormone in comparison. Pharm Acta Helv, 1996;71(6):405-19.
9. Cruz L, Assumpção E, Andrade SF, Conrado DJ, Kulkamp IC, Guterres SS, Pohlmann AR. Gastroresistant microparticles containing sodium alendronate prevent the bone loss in ovariectomized rats. Eur J Pharm Sci, 2010;40(5):441-7.
10. Dawes GJ, Fratila-Apachitei LE, Mulia K, Apachitei I, Witkamp GJ, Duszczyk J. Size effect of PLGA spheres on drug loading efficiency and release profiles. J Mater Sci - Mater Med, 2009;20(5):1089-94.
11. des Rieux A, Fievez V, Garinot M, Schneider YJ, Préat V. Nanoparticles as potential oral delivery systems of proteins and vaccines: A mechanistic approach. J Control Release, 2006;116(1):1-27.
12. Devarajan PV, Sonavane GS. Preparation and in vitro/in vivo evaluation of gliclazide loaded Eudragit nanoparticles as a sustained release carrier. Drug Dev Ind Pharm, 2007;33(2):101-11.
13. Eaimtrakarn S, Itoh Y, Kishimoto J, Yoshikawa Y, Shibata N, Murakami M, Takada K. Gastrointestinal mucoadhesive patch system (GI-MAPS) for oral administration of G-CSF, a model protein. Biomaterials, 2002;23(1):145-52.
14. Eaimtrakarn S, Itoh Y, Kishimoto JI, Yoshikawa Y, Shibata N, Takada K. Retention and transit of intestinal mucoadhesive films in rat small intestine. Int J Pharm, 2001;224(1-2):61-7.
15. Eerikäinen H, Peltonen L, Raula J, Hirvonen J, Kauppinen EI. Nanoparticles containing ketoprofen and acrylic polymers prepared by an aerosol flow reactor method. AAPS PharmSciTech, 2004;5(4):e68.
16. European pharmacopoeia. 2001. 3rd edition (Suppl.). Strasbourg Cedex, France: Council of Europe, p.S526.
17. Garcia-Fuentes M, Prego C, Torres D, Alonso MJ. A comparative study of the potential of solid triglyceride nanostructures coated with chitosan or poly(ethylene glycol) as carriers for oral calcitonin delivery. Eur J Pharm Sci, 2005;25(1):133-43.
18. Glowka E, Sapin-Minet A, Leroy P, Lulek J, Maincent P. Preparation and in vitro-in vivo evaluation of salmon calcitonin-loaded polymeric nanoparticles. J Microencapsul, 2010;27(1):25-36.
19. Guggi D, Bernkop-Schnürch A. In vitro evaluation of polymeric excipients protecting calcitonin against degradation by intestinal serine proteases. Int J Pharm, 2003;252(1-2):187-96.
20. Guggi D, Kast CE, Bernkop-Schnürch A. In vivo evaluation of an oral salmon calcitonin-delivery system based on a thiolated chitosan carrier matrix. Pharm Res, 2003;20(12):1989-94.
21. Hee Lee Y, Leesman GD, Makhey V, Yu H, Hu P, Perry B, Sutyak JP, Wagner EJ, Falzone LM, Stern W, et al. Regional oral absorption, hepatic first-pass effect, and non-linear disposition of salmon calcitonin in beagle dogs. Eur J Pharm Biopharm, 2000;50(2):205-11.
22. Hirai S, Yasbiki T, Mima H. Effect of surfactants to nasal absorption of insulin in rats. Int J Pharm, 1981;9:165-72.
23. International Conference on Harmonization (ICH). Q2b: Validation of analytical procedures: Methodology. US FDA Fed Reg, 1997;62:27463.
24. Jawahar N, Eagappanath T, Venkatesh N, Jubie S, Samanta MK. Preparation and characterisation of PLGA-nanoparticles containing an anti-hypertensive agent. Int J PharmTech Res, 2009;1(2):390-3.
25. Jung T, Kamm W, Breitenbach A, Kaiserling E, Xiao JX, Kissel T. Biodegradable nanoparticles for oral delivery of peptides: Is there a role for polymers to affect mucosal uptake? Eur J Pharm Biopharm, 2000;50(1):147-60.
26. Jung TS, Kwon BS, Lee HE, Kim AY, Lee MJ, Park CR, Kang HK, Kim YD, Lee SK, Kang JS, et al. Enhanced oral absorption of salmon calcitonin-encapsulated PLGA nanoparticles by adding organic substances. Korean J Chem Eng, 2009;26(1):131-5.
27. Karn PR, Vanić Z, Pepić I, Skalko-Basnet N. Mucoadhesive liposomal delivery systems: The choice of coating material. Drug Dev Ind Pharm, 2011;37(4):482-8.
28. Kim BK, Hwang SJ, Park JB, Park HJ. Preparation and characterization of drug-loaded polymethacrylate microspheres by an emulsion solvent evaporation method. J Microencapsul, 2002;19(6):811-22.
29. Kuksal A, Tiwary AK, Jain NK, Jain S. Formulation and in vitro, in vivo evaluation of extended-release matrix tablet of zidovudine: Influence of combination of hydrophilic and hydrophobic matrix formers. AAPS PharmSciTech, 2006;7(1):E1.
30. Li YP, Pei YY, Zhou ZH, Zhang XY, Gu ZH, Ding J, Zhou JJ, Gao XJ. PEGylated polycyanoacrylate nanoparticles as tumor necrosis factoralpha carriers. J Control Release, 2001;71(3):287-96.
31. Li JK, Wang N, Wu XS. Poly(vinyl alcohol) nanoparticles prepared by freezing- thawing process for protein/peptide drug delivery. J Control Release, 1998;56(1-3):117-26.
32. Lopedota A, Trapani A, Cutrignelli A, Chiarantini L, Pantucci E, Curci R, Manuali E, Trapani G. The use of Eudragit RS 100/cyclodextrin nanoparticles for the transmucosal administration of glutathione. Eur J Pharm Biopharm, 2009;72(3):509-20.
33. Makhlof A, Werle M, Tozuka Y, Takeuchi H. A mucoadhesive nanoparticulate system for the simultaneous delivery of macromolecules and permeation enhancers to the intestinal mucosa. J Control Release, 2011;149(1):81-8.
34. Mansoor S, Youn YS, Lee KC. Oral delivery of mono-PEGylated sCT (Lys18) in rats: Regional difference in stability and hypocalcemic effect. Pharm Dev Technol, 2005;10(3):389-96.
35. Mark P, Ettinger MD. Aging bone and osteoporosis strategies for preventing fractures in the elderly. Arch Intern Med, 2003;163:2237-46.
36. Mohanraj VJ, Chen Y. Nanoparticles - a review. Trop J Pharm Res, 2006;5(1):561-73.
37. Morishita I, Morishita M, Takayama K, Machida Y, Nagai T. Enteral insulin delivery by microspheres in 3 different formulations using Eudragit L100 and S100. Int J Pharm, 1993;91(1):29-37.
38. Mukherjee B, Santra K, Pattnaik G, Ghosh S. Preparation, characterization and in-vitro evaluation of sustained release protein-loaded nanoparticles based on biodegradable polymers. Int J Nanomed, 2008;3(4):487-96.
39. Patel VF, Liu F, Brown MB. Advances in oral transmucosal drug delivery. J Control Release, 2011;153(2):106-16.
40. Pinto RC, Neufeld RJ, Ribeiro AJ, Veiga F. Nanoencapsulation II. Biomedical applications and current status of peptide and protein nanoparticulate delivery systems. Nanomedicine, 2006;2(2):53-65.
41. Rowe RC, Sheskey PJ, Owen SC. (eds.). 2006. Handbook of pharmaceutical excipients. London, Washington: Pharmaceutical Press and American Pharmacists Association.
42. Saha P, Goyal AK, Rath G. Formulation and evaluation of chitosanbased ampicillin trihydrate nanoparticles. Trop J Pharm Res, 2010;9(5):483-8.
43. Sakuma S, Suzuki N, Kikuchi H, Hiwatari K-I, Arikawa K, Kishida A, Akashi M. Oral peptide delivery using nanoparticles composed of novel graft copolymers having hydrophobic backbone and hydrophilic branches. Int J Pharm, 1997;149(1):93-106.
44. Samstein RM, Perica K, Balderrama F, Look M, Fahmy TM. The use of deoxycholic acid to enhance the oral bioavailability of biodegradable nanoparticles. Biomaterials, 2008;29(6):703-8.
45. Saremi S, Atyabi F, Akhlaghi SP, Ostad SN, Dinarvand R. Thiolated chitosan nanoparticles for enhancing oral absorption of docetaxel: Preparation, in vitro and ex vivo evaluation. Int J Nanomed, 2011;6:119-28.
46. Sarmento B. 2008. The oral delivery of therapeutic proteins [Online]. Available at: http://www.scitopics.com/The-oral-delivery-of- therapeutic-proteins.html. Accessed 15 March 2011.
47. Shah RB, Khan MA. Regional permeability of salmon calcitonin in isolated rat gastrointestinal tracts: Transport mechanism using Caco-2 cell monolayer. AAPS J, 2004;6(4):e31.
48. Shaji J, Patole V. Protein and peptide drug delivery: Oral approaches. Indian J Pharm Sci, 2008;70:269-77.
49. Sigurdsson HH, Knudsen E, Loftsson T, Leeves N, Sigurjonsdottir JF, Másson M. Mucoadhesive sustained drug delivery system based on cationic polymer and anionic cyclodextrin/triclosan complex. J Inclusion Phenom Macrocyclic Chem, 2002;44:169-72.
50. Sinko PJ, Smith CL, McWhorter LT, Stern W, Wagner E, Gilligan JP. Utility of pharmacodynamic measures for assessing the oral bioavailability of peptides. 1. Administration of recombinant salmon calcitonin in rats. J Pharm Sci, 1995;84(11):1374-8.
51. Song IS, Chung SJ, Shim CK. Contribution of ion pair complexation with bile salts to biliary excretion of organic cations in rats. Am J Physiol Gastrointest Liver Physiol, 2001;281(2):G515-25.
52. Song KH, Chung SJ, Shim CK. Enhanced intestinal absorption of salmon calcitonin (sCT) from proliposomes containing bile salts. J Control Release, 2005;106(3):298-308.
53. Song X, Zhao Y, Hou S, Xu F, Zhao R, He J, Cai Z, Li Y, Chen Q. Dual agents loaded PLGA nanoparticles: Systematic study of particle size and drug entrapment efficiency. Eur J Pharm Biopharm, 2008;69(2):445-53.
54. Sood A, Panchagnula R. Peroral route: An opportunity for protein and peptide drug delivery. Chem Rev, 2001;101(11):3275-303.
55. Takada K, Ushirogawa Y. Effect of pH, dietary proteins and trypsin inhibitors on the hydrolytic rate of human granulocyte colony-stimulating factor (G-CSF) by rat digestive enzymes. J Pharmacobiodyn, 1991;14(7):363-70.
56. Varaprasad Reddy M, Sudheer Babu I. Chitosan versus thiolated chitosans as polymers in mucoadhesive drug delivery - a comparative study. IRJP, 2010;1(1):81-8.