Particle design of membrane emulsification for protein drug and vaccine delivery

Current Pharmaceutical Design

Volumn 21, Issue 19, 2015, Pages 2563-2598

  Wang, Lianyan ^a   Yang, Tingyuan ^a   Ma, Guanghui ^a  

^a INSTITUTE OF PROCESS ENGINEERING   (China)

Author keywords

Adjuvant; Bioactivity; Membrane emulsification; Microparticle; Protein peptide drugs

Indexed keywords

MICROSPHERE; PROTEIN; VACCINE; DRUG; EMULSION;

ARTICLE; BIOCOMPATIBILITY; CONTACT ANGLE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG RELEASE; EMULSION; ENCAPSULATION; HUMAN; HYDROPHILICITY; HYDROPHOBICITY; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; INTERNALIZATION; MEMBRANE EMULSIFICATION; MICROCAPSULE; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; PROTEIN CROSS LINKING; PROTEIN DENATURATION; PROTEIN SECRETION; PROTEIN UNFOLDING; SURFACE CHARGE; ADMINISTRATION AND DOSAGE; CELL MEMBRANE; CHEMISTRY; DRUG DESIGN; SURFACE PROPERTY;

CELL MEMBRANE; DRUG DELIVERY SYSTEMS; DRUG DESIGN; EMULSIONS; HUMANS; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; PROTEINS; SURFACE PROPERTIES; VACCINES;

EID: 84930724176     PISSN: 13816128     EISSN: 18734286     Source Type: Journal    
DOI: 10.2174/1381612821666150416100031     Document Type: Article

References (97)

1. [1] Bilati U, Allemann E, Doelker E. Strategic approaches for overcoming peptide and protein instability within biodegradable nanoand microparticles. Eur J Pharm Biopharm 2005; 59: 375-88.
2. [2] Sola RJ, Griebenow K. Effects of Glycosylation on the Stability of Protein Pharmaceuticals. J Pharm Sci 2009; 98: 1223-45.
3. [3] Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008; 372: 1240-50.
4. [4] Singh M, O'Hagan D. Advances in vaccine adjuvants. Nat Biotechnol 1999; 17: 1075-81.
5. [5] Wischke C, Mathew S, Roch T, et al. Potential of NOD receptor ligands as immunomodulators in particulate vaccine carriers. J Control Release 2012; 164: 299-306.
6. [6] Yanasarn N, Sloat BR, Cui Z. Negatively charged liposomes show potent adjuvant activity when simply admixed with protein antigens. Mol Pharmaceutics 2011; 8: 1174-85.
7. [7] Meng FT, Ma GH, Liu YD, et al. Microencapsulation of bovine hemoglobin with high bioactivity and high entrapment efficiency using a W/O/W double emulsion technique. Colloids Surf B 2004; 33: 177-83.
8. [8] Galloway AL, Murphy A, DeSimone JM, et al. Development of a nanoparticle-based influenza vaccine using the PRINT® technology. Nanomed Nanotechnol Biol Med 2013; 9: 523-31.
9. [9] Shi HS, Gong CY, Zhang HL, et al. Novel vaccine adjuvant LPSHydrogel for truncated basic fibroblast growth factor to induce antitumor immunity. Carbohydr Polym 2012; 89: 1101-9.
10. [10] Manolova V, Flace A, Bauer M, et al. Nanoparticles target distinct dendritic cell populations according to their size. Eur J Immunol 2008; 38: 1404-13.
11. [11] Sharp FA, Ruane D, Claass B, et al. Uptake of particulate vaccine adjuvants by dendritic cells activates the NALP3 inflammasome. Proc Natl Acad Sci USA 2009; 106: 870-5.
12. [12] Harris J, Sharp FA, Lavelle EC. The role of inflammasomes in the immunostimulatory effects of particulate vaccine adjuvants. Eur J Immunol 2010; 40: 634-8.
13. [13] Broaders KE, Cohen JA, Beaudette TT, et al. Acetalated dextran is a chemically and biologically tunable material for particulate immunotherapy. Proc Natl Acad Sci 2009; 106: 5497-502.
14. [14] Yanasarn N, Sloat BR, Cui Z. Negatively charged liposomes show potent adjuvant activity when simply admixed with protein antigens. Mol Pharm 2011; 8: 1174-85.
15. [15] Zaharoff DA, Rogers CJ, Hance KW, et al. Chitosan solution enhances both humoral and cell-mediated immune responses to subcutaneous vaccination. Vaccine 2007; 25: 2085-94.
16. [16] Stevenson CL. Advances in peptide pharmaceuticals. Curr Pharm Biotechnol 2009; 10: 122-37.
17. [17] Van De Weert M, Hennink WE, Jiskoot W. Protein instability in poly(lactic-co-glycolic acid) microparticles. Pharm Res 2000; 17: 1159-67.
18. [18] Meinel L, Illi OE, Zapf J, et al. Stabilizing insulin-like growth factor-I in poly(D, L-lactideco-glycolide) microspheres. J Control Release 2001; 70: 193-202.
19. [19] Yadav SC, Kumari A, Yadav R. Development of peptide and protein nanotherapeutics by nanoencapsulation and nanobioconjugation. Peptides 2011; 32: 173-87.
20. [20] Varshochian R, Jeddi-Tehrani M, Mahmoudi AR, et al. The protective effect of albumin on bevacizumab activity and stability in PLG nanoparticles intended for retinal and choroidal neovascularization treatments. Eur J Pharm Sci 2013; 50: 341-52.
21. [21] Ma GH, Nagai M, Omi S. Preparation of uniform poly(lactide) microspheres by employing SPG emulsification technique. Colloids Surf A 1999; 153: 383-94.
22. [22] Liu R, Ma GH, Meng FT, et al. Preparation of uniform-sized PLA microcapsules by combining Shirasu Porous Glass membrane emulsification technique and multiple emulsion-solvent evaporation method. J Control Release 2005; 103: 31-43.
23. [23] Liu R, Ma GH, Wan YH, et al. Influence of process parameters on the size distribution of PLA microcapsules prepared by combining membrane emulsification technique and double emulsion-solvent evaporation method. Colloids Surf B 2005; 45: 144-53.
24. [24] Liu R, Huang SS, Wan YH, et al. Preparation of insulin-loaded PLA/PLGA microcapsules by a novel membrane emulsification method and its release in vitro. Colloids Surf B 2006; 51: 30-8.
25. [25] Wang LY, Ma GH, Su ZG. Preparation of uniform sized chitosan microspheres by membrane emulsification technique and application as a carrier of protein drug. J Control Release 2005; 106: 62-75.
26. [26] Wang LY, Gu YH, Su ZG, et al. Preparation and improvement of release behavior of chitosan microspheres containing insulin. Int J Pharm 2006; 311: 187-95.
27. [27] Wang LY, Gu YH, Zhou QZ, et al. Preparation and characterization of uniform-sized chitosan microspheres containing insulin by membrane emulsification and a two-step solidification process. Colloids Surf B 2006; 50: 126-35.
28. [28] Zhou QZ, Liu XY, Liu SJ, et al. Preparation of uniformly sized agarose microcapsules by membrane emulsification for application in sorting bacteria. Ind Eng Chem Res 2008; 47: 6386-90.
29. [29] Zhang YL, Wei W, Lv PP, et al. Preparation and evaluation of alginate-chitosan microspheres for oral delivery of insulin. Eur J Pharm Biopharm 2011; 77: 11-9.
30. [30] Wei Q, Wei W, Lai B, et al. Uniform-sized PLA nanoparticles: preparation by premix membrane emulsification. Int J Pharm 2008; 359: 294-7.
31. [31] Wei Q, Wei W, Tian R, et al. Preparation of uniform-sized PELA microspheres with high encapsulation efficiency of antigen by premix membrane emulsification. J Colloid Interf Sci 2008; 323: 267-73.
32. [32] Lv PP, Wei W, Gong FL, et al. Preparation of uniformly sized chitosan nanospheres by a premix membrane emulsification technique. Ind Eng Chem Res 2009; 48: 8819-28.
33. [33] Lv PP, Wei W, Yue H, et al. Porous quaternized chitosan nanoparticles containing paclitaxel nanocrystals improved therapeutic efficacy in non-small-cell lung cancer after oral administration. Biomacromolecules 2011; 12: 4230-9.
34. [34] Fu K, Klibanov AM, Langer R. Protein stability in controlledrelease systems. Nat Biotechnol 2000; 18: 24-5.
35. [35] Rathore N, Rajan RS. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Progr 2008; 24: 504-14.
36. [36] Ruan G, Feng SS, Li QT. Effects of material hydrophobicity on physical properties of polymeric microspheres formed by double emulsion process. J Control Release 2002; 84: 151-60.
37. [37] Gupta PN, Mahor S, Rawat A, et al. Lectin anchored stabilized biodegradable nanoparticles for oral immunization: 1. Development and in vitro evaluation. Int J Pharmaceut 2006; 318: 163-73.
38. [38] Kim H, Na K. Evaluation of succinylated pullulan for long-term protein delivery in poly(lactide-co-glycolide) microspheres. Macromol Res 2010; 18: 812-9.
39. [39] Park W, Na K. Dermatan sulfate as a stabilizer for protein stability in poly (lactide-co-glycolide) depot. Biotechnol Bioproc E 2009; 14: 668-74.
40. [40] Pèrez C, Griebenow K. Improved activity and stability of lysozyme at the water/methylene chloride interface: enzymeunfolding and aggregation and its prevention by polyols. J Pharm Pharmacol 2001; 53: 1217-26.
41. [41] Manoharan C, Singh J. Insulin loaded PLGA microspheres: effect of zinc salts on encapsulation, release, and stability. J Pharm Sci 2009; 98: 529-42.
42. [42] Zhao HP, Wu F, Cai YP, et al. Local antitumor effects of intratumoral delivery of rlL-2 loaded sustained-release dextran/PLGA– PLA core/shell microspheres. Int J Pharm 2013; 450: 235-40.
43. [43] Amidi M, Mastrobattista E, Jiskoot W, et al. Chitosan-based delivery systems for protein therapeutics and antigens. Adv Drug Deliv Rev 2010; 62: 59-82.
44. [44] Amidi M, Romeijn SG, Borchard G, et al. Preparation and characterization of protein-loaded N-trimethyl chitosan nanoparticles as nasal delivery system. J Control Release 2006; 111: 107-16.
45. [45] Vila A, Sánchez A, Janes K, et al. Low molecular weight chitosan nanoparticles as new carriers for nasal vaccine delivery in mice. Eur J Pharm Biopharm 2004; 57: 123-31.
46. [46] Ma Z, Lim TM, Lim LY. Pharmacological activity of peroral chitosan- insulin nanoparticles in diabetic rats. Int J Pharmaceut 2005; 293: 271-80.
47. [47] Amidi M, Romeijn SG, Verhoef JC, et al. N-Trimethyl chitosan (TMC) nanoparticles loaded with influenza subunit antigen for intranasal vaccination: Biological properties and immunogenicity in a mouse model. Vaccine 2007; 25: 144-53.
48. [48] Merkus FWHM, Verhoef JC, Marttin E, et al. Cyclodextrins in nasal drug delivery. Adv Drug Deliv Rev 1999; 36: 41-57.
49. [49] Min KH, Park K, Kim YS, et al. Hydrophobically modified glycol chitosan nanoparticle-encapsulated camptothecin enhance the drug stability and tumor targeting in cancer therapy. J Control Release 2008; 127: 208-18.
50. [50] Sharma G, Valenta DT, Altman Y, et al. Polymer particle shape independently influences binding and internalization by macrophages. J Control Release 2010; 147: 408-12.
51. [51] Champion J, Mitragotri S. Shape induced inhibition of phagocytosis of polymer particles. Pharm Res 2009; 26: 244-9.
52. [52] Geng Y, Dalhaimer P, Cai S, et al. Shape effects of filaments versus spherical particles in flow and drug delivery. Nat Nanotechnol 2007; 2: 249-55.
53. [53] Xiang SD, Scholzen A, Minigo G, et al. Pathogen recognition and development of particulate vaccines: Does size matter. Methods 2006; 40: 1-9.
54. [54] Foged C, Brodin B, Frokjaer S, et al. Particle size and surface charge affect particle uptake by human dendritic cells in an in vitro model. Int J Pharm 2005; 298: 315-22.
55. [55] Tabata Y, Ikada Y. Effect of the size and surface charge of polymer microspheres on their phagocytosis by macrophage. Biomaterials 1988; 9: 356-62.
56. [56] Thomas C, Gupta V, Ahsan F. Particle size influences the immune response produced by hepatitis B vaccine formulated in inhalable particles. Pharm Res 2010; 27: 905-19.
57. [57] Gutierro I, Hernandez RM, Igartua M, et al. Size dependent immune response after subcutaneous, oral and intranasal administration of BSA loaded nanospheres. Vaccine 2002; 21: 67-77.
58. [58] He CB, Hu YP, Yin LC, et al. Effects of particle size and surface charge on cellular uptake and biodistribution of polymeric nanoparticles. Biomaterials 2010; 31: 3657-66.
59. [59] Wang LY. Wu J. Wei W, et al. Preparation and Applications of Chitosan Microsphere. Curr Res Develop Chitin Chitosan Biomater Sci 2008; 1: 143-63.
60. [60] Sonaje K, Lin KJ, Wang JJ, et al. Self-assembled pH-sensitive nanoparticles: A platform for oral delivery of protein drugs. Adv Funct Mater 2010; 20: 3695-700.
61. [61] Hejazi R, Amiji M. Chitosan-based gastrointestinal delivery systems. J Control Release 2003; 89: 151-65.
62. [62] Chaturvedi K, Ganguly K, Nadagouda MN, et al. Polymeric hydrogels for oral insulin delivery. J Control Release 2013; 165: 129-38.
63. [63] Leong KH, Chung LY, Noordin MI, et al. Lectin-functionalized carboxymethylated kappa-carrageenan microparticles for oral insulin delivery. Carbohydr Polym 2011; 86: 555-65.
64. [64] Yeh TH, Hsu LW, Tseng MT, et al. Mechanism and consequence of chitosan-mediated reversible epithelial tight junction opening. Biomaterials 2011; 32: 6164-73.
65. [65] Yin L, Ding J, He C, et al. Drug permeability and mucoadhesion properties of thiolated trimethyl chitosan nanoparticles in oral insulin delivery. Biomaterials 2009; 30: 5691-700.
66. [66] Sonia TA, Rekha MR, Sharma CP. Bioadhesive hydrophobic chitosan microparticles for oral delivery of insulin: In vitro characterization and in vivo uptake studies. J Appl Polym Sci 2011; 119: 2902-10.
67. [67] Omidian H, Park K, Rocca JG. Recent developments in superporous hydrogels. J Pharm Pharmacol 2007; 59: 317-27.
68. [68] Yin L, Ding J, Fei L, et al. Beneficial properties for insulin absorption using superporous hydrogel containing interpenetrating polymer network as oral delivery vehicles. Int J Pharmaceut 2008; 350: 220-9.
69. [69] Yamagata T, Morishita M, Kavimandan NJ, et al. Characterization of insulin protection properties of complexation hydrogels in gastric and intestinal enzyme fluids. J Control Release 2006; 112: 343-9.
70. [70] Mi FL, Wu YY, Lin YH, et al. Oral delivery of peptide drugs using nanoparticles self-Assembled by poly(glutamic acid) and a chitosan derivative functionalized by trimethylation. Bioconjugate Chem 2008; 19: 1248-55.
71. [71] Qi F, Wu J, Hao D, et al. Comparative studies on the influences of primary emulsion preparation on properties of uniform-sized exenatide- loaded PLGA microspheres. Pharm Res 2014; 31: 1566-74.
72. [72] Wei Y, Wang YX, Wang LY, et al. Fabrication strategy for amphiphilic microcapsules with narrow size distribution by premix membrane emulsification. Colloids Surf B 2011; 87: 399-408.
73. [73] Sah HK, Toddyywala R, Chien YW. The influence of biodegradable microcapsule formulations on the controlled release of a protein. J Control Release 1994; 30: 201-11.
74. [74] Dai C, Wang B, Zhao H. Microencapsulation peptide and protein drugs delivery system. Colloids Surf B: Biointerf 2005; 41: 117-20.
75. [75] Van de Weert M, Hoechstetter J, Hennink WE, et al. The effect of a water/organic solvent interface on the structural stability of lysozyme. J Control Release 2000; 68: 351-9.
76. [76] Morlock M, Koll H, Winter G, et al. Microencapsulation of rherythropoietin, using biodegradable poly(D, L-lactide-co-glycolide): protein stability and the effects of stabilizing excipients. Eur J Pharm Biopharm 1997; 43: 29-36.
77. [77] Meng FT, Zhang WZ, Ma GH, et al. The preparation and characterization of monomethoxy-poly(ethylene glycol)-b-poly-DLlactide microcapsules containing bovine hemoglobin. Artif Cells Blood Substit Immobil Biotechnol 2003; 31: 281-95.
78. [78] Byler DM, Susi H. Examination of the secondary structure of proteins by deconvolved FTIR spectra. Biopolymer 1986; 25: 469-87.
79. Liu R. Study on preparation of PLA or PLGA microcapsules loading bio-drugs by a novel membrane emulsification technique, Institute of Process Engineering, Chinese Academy of Sciences 2006: Chapter 5 in PhD thesis.
80. [80] Charman SA, Mason KL, Charman WN. Techniques for assessing the effects of pharmaceutical excipients on the aggregation of porcine growth hormone. Pharm Res 1993; 10: 954-62.
81. [81] Meng FT, Ma GH, Qiu W, et al. W/O/W double emulsion technique using ethyl acetate as organic solvent: effect of its diffusion rate on the characterization of microparticles. J Control Release 2003; 91: 407-16.
82. [82] Wei Y, Wang YX, Kang AJ, et al. A novel sustained-release formulation of recombinant human growth hormone and its pharmacokinetic, pharmacodynamic and safety profiles. Mol Pharm 2012; 9: 2039-48.
83. [83] Ma TT, Wang LY, Yang TY, et al. PLGA-lipid liposphere as a promising platform for oral delivery of proteins. Colloids Surf B Biointerfaces 2014; 117: 512-9.
84. [84] Zhang YL, Wei W, Lv PP, et al. Preparation and evaluation of alginate-chitosan microspheres for oral delivery of insulin. Eur J Pharm Biopharm 2011; 77: 11-9.
85. [85] Wu J, Su ZG, Ma GH. A thermo- and pH-sensitive hydrogel composed of quaternized chitosan/glycerophosphate. Int J Pharm 2006; 315: 1-11.
86. [86] Wu J, Wei W, Wang LY, et al. Preparation of uniform-sized pHsensitive quaternized chitosan microsphere by combining membrane emulsification technique and thermal-gelation method. Colloids Surf. B 2008; 63: 164-75.
87. [87] Wei W, Yuan L, Hu G, et al. Monodisperse chitosan microspheres with interesting structures for protein drug delivery. Adv Mater 2008; 20: 2292-6.
88. [88] Wei W, Wang LY, Yuan L, et al. Preparation and application of novel microspheres possessing autofluorescent properties. Adv Funct Mater 2007; 17: 3153-8.
89. [89] Wei W, Ma GH, Wang LY, et al. Hollow quaternized chitosan microspheres increase the therapeutic effect of orally administered insulin. Acta Biomat 2010; 6: 205-9.
90. [90] Liu Y, Yin Y, Wang LY, et al. Surface hydrophobicity of microparticles modulates adjuvanticity. J Mat Chem 2013; 1: 3888-96.
91. [91] Zhang WF, Wang LY, Liu Y, et al. Comparison of PLA Microparticles and Alum as Adjuvants for H5N1 Influenza Split Vaccine: Adjuvanticity Evaluation and Preliminary Action Mode Analysis. Pharmaceut Res 2014; 31: 1015-31.
92. [92] Chen XM, Liu YY, Wang LY, et al. Enhanced humoral and cellmediated immune responses generated by cationic polymer-coated PLA microspheres with adsorbed HBsAg. Mol Pharm 2014; 11: 1772-84.
93. [93] Liu YY, Chen XM, Wang LY, et al. Surface charge of PLA microparticles in regulation of antigen loading, macrophage phagocytosis and activation, and immune effects in vitro. Particuology 2014; 17: 4-7.
94. [94] Liu Y, Yin Y, Wang LY, et al. Engineering biomaterial-associated complement activation to improve vaccine efficacy. Biomacromolecules 2013; 14: 3321-8.
95. [95] Zhang WF, Wang LY, Liu Y, et al. Immune responses to vaccines involving a combined antigen-nanoparticle mixture and nanoparticle- encapsulated antigen formulation. Biomaterials 2014; 35: 6086-97.
96. [96] Ma TT, Wang LY, Yang TY, et al. Homogeneous PLGA-lipid nanoparticle as a promising oral vaccine delivery system for ovalbumin. Asian J Pharm Sci 2014; 9: 129-36.
97. [97] Ma TT, Wang LY, Yang TY, et al. M-cell targeted polymeric lipid nanoparticles containing a toll-like receptor agonist to boost oral immunity. Int J Pharm 2014; 473: 296-303.