Self-nanoemulsifying drug delivery systems for oral insulin delivery: In vitro and in vivo evaluations of enteric coating and drug loading

International Journal of Pharmaceutics

Volumn 477, Issue 1-2, 2014, Pages 390-398

  Li, Ping ^a   Tan, Angel ^d   Prestidge, Clive A ^c   Nielsen, Hanne Mørck ^a   Müllertz, Anette ^a,b  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c UNIVERSITY OF SOUTH AUSTRALIA   (Australia)

^d INSTITUTE OF INDUSTRIAL SCIENCE   (Japan)

Author keywords

Enteric coating; Hypoglycemia; Insulin; Oral drug delivery; Pharmacokinetic; SNEDDS

Indexed keywords

ALCOHOL; CARBOXYL GROUP; CREMOPHOR; EUDRAGIT; GELATIN; GLUCOSE; HUMAN INSULIN; MIGLYOL; NANOCAPSULE; OCTANOIN; PHOSPHOLIPID; WATER; WATER OIL CREAM;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ANTIDIABETIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CACO 2 CELL LINE; COMPLEX FORMATION; CONTROLLED STUDY; DISPERSION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG DELIVERY SYSTEM; DRUG STABILITY; DRUG TRANSPORT; ENTERIC COATED CAPSULE; FREEZE DRYING; GLUCOSE BLOOD LEVEL; HYDROGEN BOND; IN VITRO STUDY; IN VIVO STUDY; INSULIN RELEASE; MALE; MAXIMUM PLASMA CONCENTRATION; MORPHOLOGY; NANOEMULSION; NONHUMAN; PROTEIN SECONDARY STRUCTURE; RAT; SELF NANOEMULSIFYING DRUG DELIVERY SYSTEM; TIME TO MAXIMUM PLASMA CONCENTRATION; ZETA POTENTIAL;

EID: 84911371456     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.10.039     Document Type: Article

References (36)

1. M.A. Atkinson, and G.S. Eisenbarth Type 1 diabetes: new perspectives on disease pathogenesis and treatment Lancet 358 2001 221 229
2. B.J. Aungst Absorption enhancers: applications and advances AAPS J. 14 2012 10 18
3. A. Bernkop-Schnurch The use of inhibitory agents to overcome the enzymatic barrier to perorally administered therapeutic peptides and proteins J. Control. Release 52 1998 1 16
4. D. Cao, A.Y. Qiu, and X.G. Wang The structure, nature, function and researching situation of phospholipid J. Cereals Oils 2004 5
5. A.E. Clausen, and A. Bernkop-Schnurch In vitro evaluation of the permeation-enhancing effect of thiolated polycarbophil J. Pharm. Sci. 89 2000 1253 1261
6. F. Cui, K. Shi, L. Zhang, A. Tao, and Y. Kawashima Biodegradable nanoparticles loaded with insulin-phospholipid complex for oral delivery: preparation: in vitro characterization and in vivo evaluation J. Control. Release 114 2006 242 250
7. M.A. Dea-Ayuela, S. Rama-iniguez, S. Torrado-Santiago, and F. Bolas-Fernandez Microcapsules formulated in the enteric coating copolymer Eudragit L100 as delivery systems for oral vaccination against infections by gastrointestinal nematode parasites J. Drug Target 14 2006 567 575
8. J.N. Henderson, K.V. Allen, I.J. Deary, and B.M. Frier Hypoglycaemia in insulin-treated Type-2 diabetes: frequency: symptoms and impaired awareness Diabetic Med. 20 2003 1016 1021
9. H.E. Himwich, J.P. Frostig, J.F. Fazekas, and Z. Hadidian The mechanism of the symptoms of insulin hypoglycemia Am. J. Psych. 96 1939 371 385
10. L.M. Hunt, M.A. Valenzuela, and J.A. Pugh NIDDM patients' fears and hopes about insulin therapy - the basis of patient reluctance Diabetes Care 20 1997 292 298
11. V. Klang, N. Matsko, K. Raupach, N. El-Hagin, and C. Valenta Development of sucrose stearate-based nanoemulsions and optimisation through gamma-cyclodextrin Eur. J. Pharm. Biopharm. 79 2011 58 67
12. H. Li, J.H. An, J.S. Park, and K. Han Multivesicular liposomes for oral delivery of recombinant human epidermal growth factor Arch. Pharm. Res. 28 2005 988 994
13. P. Li, H.M. Nielsen, and A. Mullertz Oral delivery of peptides and proteins using lipid-based drug delivery systems Expert Opin. Drug Deliv. 9 2012 1289 1304
14. P. Li, H.M.R. Nielsen, M. Fano, and A. Mullertz Preparation and characterization of insulin- surfactant complexes for loading into lipid-based drug delivery systems J. Pharm Sci. 102 2013 2689 2698
15. X.Y. Li, J.P. Qi, Y.C. Xie, X. Zhang, S.W. Hu, Y. Xu, Y. Lu, and W. Wu Nanoemulsions coated with alginate/chitosan as oral insulin delivery systems: preparation characterization, and hypoglycemic effect in rats Int. J. Nanomed. 8 2013 23 32
16. M.L. Lorenzo-Lamosa, C. Remunan, J.L. Vila-Jato, and M.J. Alonso Design of microencapsulated chitosan microspheres for colonic drug delivery J. Control. Release 52 1998 109 118
17. E.L. Ma, H. Ma, Z. Liu, C.X. Zheng, and M.X. Duan In vitro and in vivo evaluation of a novel oral insulin formulation Acta Pharmacol. Sin. 27 2006 1382 1388
18. S.H. Mollmann, U. Elofsson, J.T. Bukrinsky, and S. Frokjaer Displacement of adsorbed insulin by Tween 80 monitored using total internal reflection fluorescence and ellipsometry Pharmaceut. Res. 22 2005 1931 1941
19. M. Morishita, and N.A. Peppas Is the oral route possible for peptide and protein drug delivery Drug Discov. 11 2006 905 910
20. S.J. Murphy, P. Smith, A.B. Shaivitz, M.I. Rossberg, and P.D. Hurn The effect of brief halothane anesthesia during daily gavage on complications and body weight in rats J Am. Assoc. Lab Anim. 40 2001 9 12
21. M.M. Niu, Y. Lu, L. Hovgaard, and W. Wu Liposomes containing glycocholate as potential oral insulin delivery systems: preparation in vitro characterization, and improved protection against enzymatic degradation Int. J. Nanomed. 6 2011 1155 1166
22. A. Pardakhty, J. Varshosaz, and A. Rouholamini In vitro study of polyoxyethylene alkyl ether niosornes for delivery of insulin Int. J. Pharmaceut. 328 2007 130 141
23. Y. Pocker, and S.B. Biswas Conformational dynamics of insulin in solution - circular dichroic studies Biochemistry (Mosc.) 19 1980 5043 5049
24. S.V.R. Rao, K. Yajurvedi, and J. Shao Self-nanoemulsifying drug delivery system (SNEDDS) for oral delivery of protein drugs: III: in vivo oral absorption study Int. J. Pharmaceut. 362 2008 16 19
25. C.M. Ripsin, H. Kang, and R.J. Urban Management of blood glucose in type 2 diabetes mellitus Am. Fam. Physician 79 2009 29 36
26. B. Sarmento, S. Martins, D. Ferreira, and E.B. Souto Oral insulin delivery by means of solid lipid nanoparticles Int. J. Nanomed. 2 2007 743 749
27. G. Sharma, K. Wilson, C.F. van der Walle, N. Sattar, J.R. Petrie, and M.N.V.R. Kumar Microemulsions for oral delivery of insulin: design: development and evaluation in streptozotocin induced diabetic rats Eur. J. Pharm. Biopharm. 76 2010 159 169
28. K. Sonaje, Y.J. Chen, H.L. Chen, S.P. Wey, J.H. Juang, H.N. Nguyen, C.W. Hsu, K.J. Lin, and H.W. Sung Enteric-coated capsules filled with freeze-dried chitosan/poly(gamma-glutamic acid) nanoparticles for oral insulin delivery Biomaterials 31 2010 1 8
29. K. Sonaje, Y.H. Lin, J.H. Juang, S.P. Wey, C.T. Chen, and H.W. Sung In vivo evaluation of safety and efficacy of self-assembled nanoparticles for oral insulin delivery Biomaterials 30 2009 2329 2339
30. M. Thanou, J.C. Verhoef, and H.E. Junginger Oral drug absorption enhancement by chitosan and its derivatives Adv. Drug Deliv. Rev. 52 2001 117 126
31. T. Uchiyama, T. Sugiyama, Y.S. Quan, A. Kotani, N. Okada, T. Fujita, S. Muranishi, and A. Yamamoto Enhanced permeability of insulin across the rat intestinal membrane by various absorption enhancers: their intestinal mucosal toxicity and absorption-enhancing mechanism of n-lauryl-beta-d-maltopyranoside J. Pharm. Pharmacol. 51 1999 1241 1250
32. R. Waninge, E. Kalda, M. Paulsson, T. Nylander, and B. Bergenstahl Cryo-TEM of isolated milk fat globule membrane structures in cream Phys. Chem. Chem. Phys. 6 2004 1518 1523
33. D.R. Whiting, L. Guariguata, C. Weil, and J. Shaw IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030 Diabetes Res. Clin. Pract. 94 2011 311 321
34. A. Yamamoto, T. Taniguchi, K. Rikyuu, T. Tsuji, T. Fujita, M. Murakami, and S. Muranishi Effects of various protease inhibitors on the intestinal-absorption and degradation of insulin in rats Pharmaceut. Res. 11 1994 1496 1500
35. N. Zhang, Q.N. Ping, G.H. Huang, and W.F. Xu Investigation of lectin-modified insulin liposomes as carriers for oral administration Int. J. Pharmaceut. 294 2005 247 259
36. Q. Zhang, N. He, L. Zhang, F. Zhu, Q. Chen, Y. Qin, Z. Zhang, Q. Zhang, S. Wang, and Q. He The in vitro and in vivo study on self-nanoemulsifying drug delivery system (SNEDDS) based on insulin-phospholipid complex J. Biomed. Nanotechnol. 8 2012 90 97