Scalable fabrication of size-controlled chitosan nanoparticles for oral delivery of insulin

Biomaterials

Volumn 130, Issue , 2017, Pages 28-41

  He, Zhiyu ^a   Santos, Jose Luis ^b   Tian, Houkuan ^a   Huang, Huahua ^a   Hu, Yizong ^b,c   Liu, Lixin ^a   Leong, Kam W ^a,d   Chen, Yongming ^a   Mao, Hai Quan ^a,b,e  

^a SUN YAT SEN UNIVERSITY   (China)

^b Johns Hopkins University   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Department of Earth and Environmental Sciences   (United States)

^e Johns Hopkins University   (United States)

Author keywords

Chitosan nanoparticles; Flash nanocomplexation; Insulin; Oral delivery; Scalable fabrication

Indexed keywords

CHITIN; CHITOSAN; EFFICIENCY; ENCAPSULATION; INSULIN; MIXING; POLYELECTROLYTES; PROTEINS; RAT CONTROL; SOLUTIONS;

CHITOSAN NANOPARTICLES; CONTROLLED DELIVERY; ENCAPSULATION EFFICIENCY; FLASH NANOCOMPLEXATION; ORAL DELIVERY; POLYELECTROLYTE COMPLEXATION; PROTEIN NANOPARTICLES; THERAPEUTIC APPLICATION;

NANOPARTICLES;

CHITOSAN NANOPARTICLE; GLUCOSE; INSULIN; PIG INSULIN; TRIPOLYPHOSPHATE; CHITOSAN; NANOPARTICLE; POLYPHOSPHATE; TRIPHOSPHORIC ACID;

ANIMAL EXPERIMENT; ANIMAL MODEL; AQUEOUS SOLUTION; ARTICLE; CACO-2 CELL LINE; COMPLEX FORMATION; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG RELEASE; DRUG SOLUBILITY; FLASH NANOCOMPLEXATION; FREEZE DRYING; GLUCOSE BLOOD LEVEL; INSULIN DEPENDENT DIABETES MELLITUS; MALE; NANOENCAPSULATION; NANOFABRICATION; NONHUMAN; PARTICLE SIZE; PH; PRIORITY JOURNAL; PROCESS OPTIMIZATION; RAT; REPRODUCIBILITY; SCALE UP; ANIMAL; BLOOD; CHEMISTRY; DISEASE MODEL; EXPERIMENTAL DIABETES MELLITUS; HUMAN; IMPEDANCE; METABOLISM; ORAL DRUG ADMINISTRATION; PATHOLOGY; PIG; SPRAGUE DAWLEY RAT; TIGHT JUNCTION; TRANSPORT AT THE CELLULAR LEVEL; ULTRASTRUCTURE;

ADMINISTRATION, ORAL; ANIMALS; BIOLOGICAL TRANSPORT; BLOOD GLUCOSE; CACO-2 CELLS; CHITOSAN; DIABETES MELLITUS, EXPERIMENTAL; DISEASE MODELS, ANIMAL; DRUG DELIVERY SYSTEMS; ELECTRIC IMPEDANCE; FREEZE DRYING; HUMANS; HYDROGEN-ION CONCENTRATION; INSULIN; MALE; NANOPARTICLES; PARTICLE SIZE; POLYPHOSPHATES; RATS, SPRAGUE-DAWLEY; SUS SCROFA; TIGHT JUNCTIONS;

EID: 85016158300     PISSN: 01429612     EISSN: 18785905     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2017.03.028     Document Type: Article

References (58)

1. [1] Van der Burgh, S., de Keizer, A., Cohen Stuart, M.A., Complex coacervation core micelles. colloidal stability and aggregation mechanism. Langmuir 20 (2004), 1073–1084.
2. [2] Overbeek, J.T.G., Voorn, M.J., Phase separation in polyelectrolyte solutions. Theory of complex coacervation. J. Cell. Comp. Physiol. 49 (1957), 7–26.
3. [3] Kayitmazer, A.B., Thermodynamics of complex coacervation. Adv. Colloid Interface Sci. 239 (2017), 169–177, 10.1016/j.cis.2016.07.006.
4. [4] Ramasamy, T., Tran, T.H., Cho, H.J., Kim, J.H., Kim, Y.I., Jeon, J.Y., et al. Chitosan-based polyelectrolyte complexes as potential nanoparticulate carriers: physicochemical and biological characterization. Pharm. Res. 31 (2014), 1302–1314.
5. [5] Sung, H.W., Sonaje, K., Liao, Z.X., Hsu, L.W., Chuang, E.Y., pH-responsive nanoparticles shelled with chitosan for oral delivery of insulin: from mechanism to therapeutic applications. Acc. Chem. Res. 45 (2012), 619–629.
6. [6] Lin, Y.H., Sonaje, K., Lin, K.M., Juang, J.H., Mi, F.L., Yang, H.W., et al. Multi-ion-crosslinked nanoparticles with pH-responsive characteristics for oral delivery of protein drugs. J. Control. Release 132 (2008), 141–149.
7. [7] Fabregas, A., Minarro, M., Garcia-Montoya, E., Perez-Lozano, P., Carrillo, C., Sarrate, R., et al. Impact of physical parameters on particle size and reaction yield when using the ionic gelation method to obtain cationic polymeric chitosan-tripolyphosphate nanoparticles. Int. J. Pharm. 446 (2013), 199–204.
8. [8] Elsayed, A., Al-Remawi, M., Qinna, N., Farouk, A., Al-Sou'od, K.A., Badwan, A.A., Chitosan-sodium lauryl sulfate nanoparticles as a carrier system for the in vivo delivery of oral insulin. AAPS PharmSciTech 12 (2011), 958–964.
9. [9] Chen, M.C., Sonaje, K., Chen, K.J., Sung, H.W., A review of the prospects for polymeric nanoparticle platforms in oral insulin delivery. Biomaterials 32 (2011), 9826–9838.
10. [10] Santos, J.L., Ren, Y., Vandermark, J., Archang, M.M., Williford, J.-M., Liu, H.-W., et al. Continuous production of discrete plasmid DNA-polycation nanoparticles using flash nanocomplexation. Small 45 (2016), 6214–6222.
11. [11] Margulis, K., Magdassi, S., Lee, H.S., Macosko, C.W., Formation of curcumin nanoparticles by flash nanoprecipitation from emulsions. J. Colloid Interface Sci. 434 (2014), 65–70.
12. [12] Zhu, Z., Margulis-Goshen, K., Magdassi, S., Talmon, Y., Macosko, C.W., Polyelectrolyte stabilized drug nanoparticles via flash nanoprecipitation: a model study with beta-carotene. J. Pharm. Sci. 99 (2010), 4295–4306.
13. [13] Cheng, J.C., Vigil, R.D., Fox, R.O., A competitive aggregation model for flash nanoprecipitation. J. Colloid Interface Sci. 351 (2010), 330–342.
14. [14] Zhu, Z., Flash nanoprecipitation: prediction and enhancement of particle stability via drug structure. Mol. Pharm. 11 (2014), 776–786.
15. [15] Chow, S.F., Sun, C.C., Chow, A.H., Assessment of the relative performance of a confined impinging jets mixer and a multi-inlet vortex mixer for curcumin nanoparticle production. Eur. J. Pharm. Biopharm. 88 (2014), 462–471.
16. [16] Han, J., Zhu, Z., Qian, H., Wohl, A.R., Beaman, C.J., Hoye, T.R., et al. A simple confined impingement jets mixer for flash nanoprecipitation. J. Pharm. Sci. 101 (2012), 4018–4023.
17. [17] Rowe, R.C., Sheskey, P.J., Weller, P.J., Handbook of Pharmaceutical Excipients. 2006.
18. [18] Dreifke, M.B., Jayasuriya, A.A., Jayasuriya, A.C., Current wound healing procedures and potential care. Mater. Sci. Eng. C 48 (2015), 651–662.
19. [19] Liu, M., Zhang, J., Zhu, X., Shan, W., Li, L., Zhong, J., et al. Efficient mucus permeation and tight junction opening by dissociable “mucus-inert” agent coated trimethyl chitosan nanoparticles for oral insulin delivery. J. Control. Release 222 (2016), 67–77.
20. [20] Sarmento, B., Ribeiro, A., Veiga, F., Ferreira, D., Neufeld, R., Oral bioavailability of insulin contained in polysaccharide nanoparticles. Biomacromolecules 8 (2007), 3054–3060.
21. [21] Liu, M., Zhang, J., Zhu, X., Shan, W., Li, L., Zhong, J., et al. Efficient mucus permeation and tight junction opening by dissociable “mucus-inert” agent coated trimethyl chitosan nanoparticles for oral insulin delivery. J. Control. Release 222 (2016), 67–77.
22. [22] Ghaffarian, R., Muro, S., Models and methods to evaluate transport of drug delivery systems across cellular barriers. J. Vis. Exp., 2013, e50638.
23. [23] Jin, Y., Song, Y., Zhu, X., Zhou, D., Chen, C., Zhang, Z., et al. Goblet cell-targeting nanoparticles for oral insulin delivery and the influence of mucus on insulin transport. Biomaterials 33 (2012), 1573–1582.
24. [24] Shan, W., Zhu, X., Liu, M., Li, L., Zhong, J., Sun, W., et al. Overcoming the diffusion barrier of mucus and absorption barrier of epithelium by self-assembled nanoparticles for oral delivery of insulin. ACS Nano 9 (2015), 2345–2356.
25. [25] Ho, Y.P., Chen, H.H., Leong, K.W., Wang, T.H., Evaluating the intracellular stability and unpacking of DNA nanocomplexes by quantum dots-FRET. J. Control. Release 116 (2006), 83–89.
26. [26] Sarmento, B., Martins, S., Ferreira, D., Souto, E.B., Oral insulin delivery by means of solid lipid nanoparticles. Int. J. Nanomed. 2 (2007), 743–749.
27. [27] Song, L., Zhi, Z.L., Pickup, J.C., Nanolayer encapsulation of insulin-chitosan complexes improves efficiency of oral insulin delivery. Int. J. Nanomed. 9 (2014), 2127–2136.
28. [28] Sonaje, K., Lin, K.J., Tseng, M.T., Wey, S.P., Su, F.Y., Chuang, E.Y., et al. Effects of chitosan-nanoparticle-mediated tight junction opening on the oral absorption of endotoxins. Biomaterials 32 (2011), 8712–8721.
29. [29] Shah, R.B., Patel, M., Maahs, D.M., Shah, V.N., Insulin delivery methods: past, present and future. Int. J. Pharm. Investig. 6 (2016), 1–9.
30. [30] Matteucci, E., Giampietro, O., Covolan, V., Giustarini, D., Fanti, P., Rossi, R., Insulin administration: present strategies and future directions for a noninvasive (possibly more physiological) delivery. Drug Des. Devel. Ther. 9 (2015), 3109–3118.
31. [31] Arbit, E., Kidron, M., Oral insulin: the rationale for this approach and current developments. J. Diabetes Sci. Technol. 3 (2009), 562–567.
32. [32] Sonaje, K., Lin, K.J., Wey, S.P., Lin, C.K., Yeh, T.H., Nguyen, H.N., et al. Biodistribution, pharmacodynamics and pharmacokinetics of insulin analogues in a rat model: oral delivery using pH-responsive nanoparticles vs. subcutaneous injection. Biomaterials 31 (2010), 6849–6858.
33. [33] Heinemann, L., Jacques, Y., Oral insulin and buccal insulin: a critical reappraisal. J. Diabetes Sci. Technol. 3 (2009), 568–584.
34. [34] Renukuntla, J., Vadlapudi, A.D., Patel, A., Boddu, S.H., Mitra, A.K., Approaches for enhancing oral bioavailability of peptides and proteins. Int. J. Pharm. 447 (2013), 75–93.
35. [35] Makhlof, A., Tozuka, Y., Takeuchi, H., Design and evaluation of novel pH-sensitive chitosan nanoparticles for oral insulin delivery. Eur. J. Pharm. Sci. 42 (2011), 445–451.
36. [36] Des Rieux, A., Fievez, V., Garinot, M., Schneider, Y.J., Preat, V., Nanoparticles as potential oral delivery systems of proteins and vaccines: a mechanistic approach. J. Control. Release 116 (2006), 1–27.
37. [37] Porter, C.J., Trevaskis, N.L., Charman, W.N., Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs. Nat. Rev. Drug Discov. 6 (2007), 231–248.
38. [38] Mo, R., Jiang, T., Di, J., Tai, W., Gu, Z., Emerging micro- and nanotechnology based synthetic approaches for insulin delivery. Chem. Soc. Rev. 43 (2014), 3595–3629.
39. [39] Florence, A.T., Nanoparticle uptake by the oral route: fulfilling its potential?. Drug Discov. Today Technol. 2 (2005), 75–81.
40. [40] Rekha, M.R., Sharma, C.P., Oral delivery of therapeutic protein/peptide for diabetes–future perspectives. Int. J. Pharm. 440 (2013), 48–62.
41. [41] Sonaje, K., Lin, Y.H., Juang, J.H., Wey, S.P., Chen, C.T., Sung, H.W., In vivo evaluation of safety and efficacy of self-assembled nanoparticles for oral insulin delivery. Biomaterials 30 (2009), 2329–2339.
42. [42] Lopes, M., Shrestha, N., Correia, A., Shahbazi, M.-A., Sarmento, B., Hirvonen, J., et al. Dual chitosan/albumin-coated alginate/dextran sulfate nanoparticles for enhanced oral delivery of insulin. J. Control. Release 232 (2016), 29–41.
43. [43] Shrestha, N., Araújo, F., Shahbazi, M.-A., Mäkilä, E., Gomes, M.J., Airavaara, M., et al. Oral hypoglycaemic effect of GLP-1 and DPP4 inhibitor based nanocomposites in a diabetic animal model. J. Control. Release 232 (2016), 113–119.
44. [44] Ensign, L.M., Cone, R., Hanes, J., Oral drug delivery with polymeric nanoparticles: the gastrointestinal mucus barriers. Adv. Drug Deliv. Rev. 64 (2012), 557–570.
45. [45] Xu, Q., Boylan, N.J., Cai, S., Miao, B., Patel, H., Hanes, J., Scalable method to produce biodegradable nanoparticles that rapidly penetrate human mucus. J. Control. Release 170 (2013), 279–286.
46. [46] Oh, E., Delehanty, J.B., Sapsford, K.E., Susumu, K., Goswami, R., Blanco-Canosa, J.B., et al. Cellular uptake and fate of PEGylated gold nanoparticles is dependent on both cell-penetration peptides and particle size. ACS Nano 5 (2011), 6434–6448.
47. [47] Ensign, L.M., Schneider, C., Suk, J.S., Cone, R., Hanes, J., Mucus penetrating nanoparticles: biophysical tool and method of drug and gene delivery. Adv. Mater. 24 (2012), 3887–3894.
48. [48] Tang, B.C., Dawson, M., Lai, S.K., Wang, Y.Y., Suk, J.S., Yang, M., et al. Biodegradable polymer nanoparticles that rapidly penetrate the human mucus barrier. Proc. Natl. Acad. Sci. U. S. A. 106 (2009), 19268–19273.
49. [49] Pridgen, E.M., Alexis, F., Farokhzad, O.C., Polymeric nanoparticle drug delivery technologies for oral delivery applications. Expert Opin. Drug Deliv. 12 (2015), 1459–1473.
50. [50] Johnson, B.K., Prud'homme, R.K., Chemical processing and micromixing in confined impinging jets. AIChE J. 49 (2003), 2264–2282.
51. [51] Liu, Y., Cheng, C., Prud'homme, R.K., Fox, R.O., Mixing in a multi-inlet vortex mixer (MIVM) for flash nano-precipitation. Chem. Eng. Sci. 63 (2008), 2829–2842.
52. [52] Liu, D., Cito, S., Zhang, Y., Wang, C.F., Sikanen, T.M., Santos, H.A., A versatile and robust microfluidic platform toward high throughput synthesis of homogeneous nanoparticles with tunable properties. Adv. Mater. 27 (2015), 2298–2304.
53. [53] Lim, J.-M., Swami, A., Gilson, L.M., Chopra, S., Choi, S., Wu, J., et al. Ultra-high throughput synthesis of nanoparticles with homogeneous size distribution using a coaxial turbulent jet mixer. ACS Nano 8 (2014), 6056–6065.
54. [54] Barichello, J.M., Morishita, M., Takayama, K., Nagai, T., Encapsulation of hydrophilic and lipophilic drugs in PLGA nanoparticles by the nanoprecipitation method. Drug Dev. Ind. Pharm. 25 (1999), 471–476.
55. [55] Ma, Z., Yeoh, H.H., Lim, L.Y., Formulation pH modulates the interaction of insulin with chitosan nanoparticles. J. Pharm. Sci. 91 (2002), 1396–1404.
56. [56] Kaarsholm, N.C., Havelund, S., Hougaard, P., Ionization behavior of native and mutant insulins: pK perturbation of B13-Glu in aggregated species. Arch. Biochem. Biophys. 283 (1990), 496–502.
57. [57] Xu, Q., Ensign, L.M., Boylan, N.J., Schön, A., Gong, X., Yang, J.-C., et al. Impact of surface polyethylene glycol (PEG) density on biodegradable nanoparticle transport in mucus ex vivo and distribution in vivo. ACS Nano 9 (2015), 9217–9227.
58. [58] Touitou, E., Rubinstein, A., Targeted enteral delivery of insulin to rats. Int. J. Pharm. 30 (1986), 95–99.