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Review

Nebulization as a delivery method for mAbs in respiratory diseases

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Bibliography

  • Vestbo J, Hurd SS, Agustí AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 2013;187(4):347-65
  • Bateman ED, Hurd SS, Barnes PJ, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J 2008;31(1):143-78
  • Reichert JM. Antibodies to watch in 2014. mAbs 2014;6(1):5-14
  • Reichert JM. Antibodies to watch in 2014: mid-year update. mAbs 2014;6(4):799-802
  • Koleba T, Ensom MH. Pharmacokinetics of intravenous immunoglobulin: a systematic review. Pharmacotherapy 2006;26(6):813-27
  • Hart TK, Cook RM, Zia-Amirhosseini P, et al. Preclinical efficacy and safety of mepolizumab (SB-240563), a humanized monoclonal antibody to IL-5, in cynomolgus monkeys. J Allergy Clin Immunol 2001;108(2):250-7
  • Dall’Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem 2006;281(33):23514-24
  • Hansel TT, Kropshofer H, Singer T, et al. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov 2010;9(4):325-38
  • Maillet A, Congy-Jolivet N, Le Guellec S, et al. Aerodynamical, immunological and pharmacological properties of the anticancer antibody cetuximab following nebulization. Pharm Res 2008;25(6):1318-26
  • Respaud R, Marchand D, Parent C, et al. Effect of formulation on the stability and aerosol performance of a nebulized antibody. mAbs 2014;6(5):1347-55
  • Lightwood D, O’Dowd V, Carrington B, et al. The discovery, engineering and characterisation of a highly potent anti-human IL-13 fab fragment designed for administration by inhalation. J Mol Biol 2013;425(3):577-93
  • Winau F, Westphal O, Winau R. Paul Ehrlich – in search of the magic bullet. Microbes Infect 2004;6(8):786-9
  • Köhler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256(5517):495-7
  • Shawler DL, Bartholomew RM, Smith LM, Dillman RO. Human immune response to multiple injections of murine monoclonal IgG. J Immunol 1985;135(2):1530-5
  • Getts DR, Getts MT, McCarthy DP, et al. Have we overestimated the benefit of human(ized) antibodies? mAbs 2010;2(6):682-94
  • Boulianne GL, Hozumi N, Shulman MJ. Production of functional chimaeric mouse/human antibody. Nature 1984;312(5995):643-6
  • Jones PT, Dear PH, Foote J, et al. Replacing the complementarity-determining regions in a human antibody with those from a mouse. Nature 1986;321(6069):522-5
  • Kim SJ, Park Y, Hong HJ. Antibody engineering for the development of therapeutic antibodies. Mol Cells 2005;20(1):17-29
  • Winter G, Harris WJ. Humanized antibodies. Trends Pharmacol Sci 1993;14(5):139-43
  • Stockwin LH, Holmes S. Antibodies as therapeutic agents: vive la renaissance!. Expert Opin Biol Ther 2003;3(7):1133-52
  • Nissim A, Chernajovsky Y. Historical development of monoclonal antibody therapeutics. Handb Exp Pharmacol 2008(181):3-18
  • Green MC, Murray JL, Hortobagyi GN. Monoclonal antibody therapy for solid tumors. Cancer Treat Rev 2000;26(4):269-86
  • Ross JS, Gray K, Gray GS, et al. Anticancer antibodies. Am J Clin Pathol 2003;119(4):472-85
  • Kaneko E, Niwa R. Optimizing therapeutic antibody function: progress with Fc domain engineering. BioDrugs 2011;25(1):1-11
  • Cartron G, Trappe RU, Solal-Céligny P, Hallek M. Interindividual variability of response to rituximab: from biological origins to individualized therapies. Clin Cancer Res 2011;17(1):19-30
  • Gelderman KA, Tomlinson S, Ross GD, Gorter A. Complement function in mAb-mediated cancer immunotherapy. Trends Immunol 2004;25(3):158-64
  • Goldenberg DM. Targeted therapy of cancer with radiolabeled antibodies. J Nucl Med 2002;43(5):693-713
  • Deng R, Jin F, Prabhu S, Iyer S. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin Drug Metab Toxicol 2012;8(2):141-60
  • Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010;49(8):493-507
  • Paintaud G. [Pharmacokinetics (PK) of mAbs]. Méd Sci(Paris) 2009;25(12):1057-62
  • Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005;36(1):3-10
  • Kuo TT, Baker K, Yoshida M, et al. Neonatal Fc receptor: from immunity to therapeutics. J Clin Immunol 2010;30(6):777-89
  • Rojas R, Apodaca G. Immunoglobulin transport across polarized epithelial cells. Nat Rev Mol Cell Biol 2002;3(12):944-55
  • Ward ES, Ober RJ. Chapter 4: multitasking by exploitation of intracellular transport functions the many faces of FcRn. Adv Immunol 2009;103:77-115
  • Tesar DB, Björkman PJ. An intracellular traffic jam: fc receptor-mediated transport of immunoglobulin G. Curr Opin Struct Biol 2010;20(2):226-33
  • Spiekermann GM, Finn PW, Ward ES, et al. Receptor-mediated immunoglobulin G transport across mucosal barriers in adult life: functional expression of FcRn in the mammalian lung. J Exp Med 2002;196(3):303-10
  • Bitonti AJ, Dumont JA, Low SC, et al. Pulmonary delivery of an erythropoietin Fc fusion protein in non-human primates through an immunoglobulin transport pathway. Proc Natl Acad Sci USA 2004;101(26):9763-8
  • Dumont JA, Bitonti AJ, Clark D, et al. Delivery of an erythropoietin-Fc fusion protein by inhalation in humans through an immunoglobulin transport pathway. J Aerosol Med 2005;18(3):294-303
  • Sakagami M, Omidi Y, Campbell L, et al. Expression and transport functionality of FcRn within rat alveolar epithelium: a study in primary cell culture and in the isolated perfused lung. Pharm Res 2006;23(2):270-9
  • Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2008;84(5):548-58
  • Sweeney TD, Marian M, Ruppel J, Bussiere J. Pulmonary delivery of anti-IgE: rationale for topical delivery to the airway. IgE and anti-IgE therapy in asthma and allergic disease. Marcel Dekker, Inc; New York: 2002
  • Kim K-J, Fandy TE, Lee VHL, et al. Net absorption of IgG via FcRn-mediated transcytosis across rat alveolar epithelial cell monolayers. Am J Physiol Lung Cell Mol Physiol 2004;287(3):L616-22
  • Maillet A, Guilleminault L, Lemarié E, et al. The airways, a novel route for delivering monoclonal antibodies to treat lung tumors. Pharm Res 2011;28(9):2147-56
  • Rabbe N, Guilleminault L, Paul F, et al. VEGF neutralizing aerosol therapy in primary pulmonary adenocarcinoma with K-ras activating-mutations. mAbs 2014;6(6):1638-48
  • Kliwinski C, Cooper PR, Perkinson R, et al. Contribution of FcRn binding to intestinal uptake of IgG in suckling rat pups and human FcRn-transgenic mice. Am J Physiol Gastrointest Liver Physiol 2013;304(3):G262-70
  • Koussoroplis SJ, Paulissen G, Tyteca D, et al. PEGylation of antibody fragments greatly increases their local residence time following delivery to the respiratory tract. J Control Release 2014;187:91-100
  • Guilleminault L, Azzopardi N, Arnoult C, et al. Fate of inhaled monoclonal antibodies after the deposition of aerosolized particles in the respiratory system. J Control Release 2014;196:344-54
  • Lombry C, Edwards DA, Préat V, Vanbever R. Alveolar macrophages are a primary barrier to pulmonary absorption of macromolecules. Am J Physiol Lung Cell Mol Physiol 2004;286(5):L1002-8
  • Holgate ST, Djukanović R, Casale T, Bousquet J. Anti-immunoglobulin E treatment with omalizumab in allergic diseases: an update on anti-inflammatory activity and clinical efficacy. Clin Exp Allergy 2005;35(4):408-16
  • Rabe KF, Calhoun WJ, Smith N, Jimenez P. Can anti-IgE therapy prevent airway remodeling in allergic asthma? Allergy 2011;66(9):1142-51
  • Holgate S, Casale T, Wenzel S, et al. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol 2005;115(3):459-65
  • Vanlandschoot P, Stortelers C, Beirnaert E, et al. Nanobodies®: new ammunition to battle viruses. Antiviral Res 2011;92(3):389-407
  • Dellamary L, Smith DJ, Bloom A, et al. Rational design of solid aerosols for immunoglobulin delivery by modulation of aerodynamic and release characteristics. J Control Release 2004;95(3):489-500
  • Schüle S, Friess W, Bechtold-Peters K, Garidel P. Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations. Eur J Pharm Biopharm 2007;65(1):1-9
  • Maury M, Murphy K, Kumar S, et al. Spray-drying of proteins: effects of sorbitol and trehalose on aggregation and FT-IR amide I spectrum of an immunoglobulin G. Eur J Pharm Biopharm 2005;59(2):251-61
  • Minne A, Boireau H, Horta MJ, Vanbever R. Optimization of the aerosolization properties of an inhalation dry powder based on selection of excipients. Eur J Pharm Biopharm 2008;70(3):839-44
  • Shoyele SA, Slowey A. Prospects of formulating proteins/peptides as aerosols for pulmonary drug delivery. Int J Pharm 2006;314(1):1-8
  • Andya JD, Maa YF, Costantino HR, et al. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody. Pharm Res 1999;16(3):350-8
  • Wang W, Singh S, Zeng DL, et al. Antibody structure, instability, and formulation. J Pharm Sci 2007;96(1):1-26
  • Steckel H, Eskandar F, Witthohn K. Effect of excipients on the stability and aerosol performance of nebulized aviscumine. J Aerosol Med 2003;16(4):417-32
  • Lentz YK, Anchordoquy TJ, Lengsfeld CS. Rationale for the selection of an aerosol delivery system for gene delivery. J Aerosol Med 2006;19(3):372-84
  • Hureaux J, Lagarce F, Gagnadoux F, et al. Lipid nanocapsules: ready-to-use nanovectors for the aerosol delivery of paclitaxel. Eur J Pharm Biopharm 2009;73(2):239-46
  • Beck-Broichsitter M, Kleimann P, Schmehl T, et al. Impact of lyoprotectants for the stabilization of biodegradable nanoparticles on the performance of air-jet, ultrasonic, and vibrating-mesh nebulizers. Eur J Pharm Biopharm 2012;82(2):272-80
  • McCallion ON, Patel MJ. Viscosity effects on nebulisation of aqueous solutions. Int J Pharm 1996;130(2):245-9
  • Davies LA, Nunez-Alonso GA, McLachlan G, et al. Aerosol delivery of DNA/liposomes to the lung for cystic fibrosis gene therapy. Hum Gene Ther Clin Dev 2014;25(2):97-107
  • Niven RW, Ip AY, Mittelman S, et al. Some factors associated with the ultrasonic nebulization of proteins. Pharm Res 1995;12(1):53-9
  • Münster AM, Bendstrup E, Jensen JI, Gram J. Jet and ultrasonic nebulization of single chain urokinase plasminogen activator (scu-PA). J Aerosol Med 2000;13(4):325-33
  • Nikander K, Turpeinen M, Wollmer P. The conventional ultrasonic nebulizer proved inefficient in nebulizing a suspension. J Aerosol Med 1999;12(2):47-53
  • Hubert D, Leroy S, Nove-Josserand R, et al. Pharmacokinetics and safety of tobramycin administered by the PARI eFlow rapid nebulizer in cystic fibrosis. J Cyst Fibros 2009;8(5):332-7
  • Sagalla RB, Smaldone GC. Capturing the efficiency of vibrating mesh nebulizers: minimizing upper airway deposition. J Aerosol Med Pulm Drug Deliv 2014;27(5):341-8
  • Vecellio L. Nebulizer choice. Nebulisation and cystic fibrosis book. Performances medicales, Paris, France; 2008; p. 26-30
  • Nikander K, Prince I, Coughlin S, et al. Mode of breathing-tidal or slow and deep-through the I-neb adaptive aerosol delivery (AAD) system affects lung deposition of (99m)Tc-DTPA. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S37-43
  • Hertel S, Pohl T, Friess W, Winter G. That’s cool! – Nebulization of thermolabile proteins with a cooled vibrating mesh nebulizer. Eur J Pharm Biopharm 2014;87(2):357-65
  • Lemarie E, Vecellio L, Hureaux J, et al. Aerosolized gemcitabine in patients with carcinoma of the lung: feasibility and safety study. J Aerosol Med Pulm Drug Deliv 2011;24(6):261-70
  • Rau JL. The inhalation of drugs: advantages and problems. Respir Care 2005;50(3):367-82
  • Beck-Broichsitter M, Oesterheld N, Knuedeler M-C, et al. On the correlation of output rate and aerodynamic characteristics in vibrating-mesh-based aqueous aerosol delivery. Int J Pharm 2014;461(1-2):34-7
  • Zhang G, David A, Wiedmann TS. Performance of the vibrating membrane aerosol generation device: aeroneb Micropump Nebulizer. J Aerosol Med 2007;20(4):408-16
  • Ghazanfari T, Elhissi AM, Ding Z, Taylor KM. The influence of fluid physicochemical properties on vibrating-mesh nebulization. Int J Pharm 2007;339(1-2):103-11
  • Rottier BL, van Erp CJP, Sluyter TS, et al. Changes in performance of the Pari eFlow rapid and Pari LC Plus during 6 months use by CF patients. J Aerosol Med Pulm Drug Deliv 2009;22(3):263-9
  • Bakuridze L, Andrieu V, Dupont C, Dubus J-C. Does repeated disinfection of the e-Flow rapid nebulizer affect in vitro performance? J Cyst Fibros 2007;6(4):309-10
  • Hardaker LE, Hatley RH. In vitro characterization of the I-neb adaptive aerosol delivery (AAD) system. J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 1):S11-20
  • Scherer T, Geller DE, Owyang L, et al. A technical feasibility study of dornase alfa delivery with eFlow® vibrating membrane nebulizers: aerosol characteristics and physicochemical stability. J Pharm Sci 2011;100(1):98-109
  • Germershaus O, Schultz I, Lühmann T, et al. Insulin-like growth factor-I aerosol formulations for pulmonary delivery. Eur J Pharm Biopharm 2013;85(1):61-8
  • Kleemann E, Schmehl T, Gessler T, et al. Iloprost-containing liposomes for aerosol application in pulmonary arterial hypertension: formulation aspects and stability. Pharm Res 2007;24(2):277-87
  • Arulmuthu ER, Williams DJ, Baldascini H, et al. Studies on aerosol delivery of plasmid DNA using a mesh nebulizer. Biotechnol Bioeng 2007;98(5):939-55
  • Hertel S, Pohl T, Friess W, Winter G. Prediction of protein degradation during vibrating mesh nebulization via a high throughput screening method. Eur J Pharm Biopharm 2014;87(2):386-94
  • Arzhavitina A, Steckel H. Surface active drugs significantly alter the drug output rate from medical nebulizers. Int J Pharm 2010;384(1-2):128-36
  • Carvalho TC, McCook JP, Narain NR, McConville JT. Development and characterization of phospholipid-stabilized submicron aqueous dispersions of coenzyme Q10 presenting continuous vibrating-mesh nebulization performance. J Liposome Res 2013;23(4):276-90
  • Dolovich MB, Macintyre NR, Anderson PJ, et al. Consensus statement: aerosols and delivery devices. J Aerosol Med 2000;13(3):291-300
  • Dautzenberg B, Fauroux B, Bonfils P, et al. [Good clinical practice in nebulization]. Ann Fr Anesthèsie Reanimation 1998;17(Suppl 2):31s-6s
  • Kim CS, Kang TC. Comparative measurement of lung deposition of inhaled fine particles in normal subjects and patients with obstructive airway disease. Am J Respir Crit Care Med 1997;155(3):899-905
  • Kim CS, Eldridge MA. Aerosol deposition in the airway model with excessive mucus secretions. J Appl Physiol(1985) 1985;59(6):1766-72
  • Depreter F, Pilcer G, Amighi K. Inhaled proteins: challenges and perspectives. Int J Pharm 2013;447(1-2):251-80
  • Filipe V, Jiskoot W, Basmeleh AH, et al. Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice. mAbs 2012;4(6):740-52
  • Barnard JG, Babcock K, Carpenter JF. Characterization and quantitation of aggregates and particles in interferon-beta products: potential links between product quality attributes and immunogenicity. J Pharm Sci 2013;102(3):915-28
  • Ratanji KD, Derrick JP, Dearman RJ, Kimber I. Immunogenicity of therapeutic proteins: influence of aggregation. J Immunotoxicol 2014;11(2):99-109
  • Ahmadi M, Bryson CJ, Cloake EA, et al. Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics. Pharm Res 2014. 10.1007/s11095-014-1541-x
  • Nechansky A, Kircheis R. Immunogenicity of therapeutics: a matter of efficacy and safety. Expert Opin Drug Discov 2010;5(11):1067-79
  • Freitag AJ, Shomali M, Michalakis S, et al. Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice. Pharm Res 2014. 10.1007/s11095-014-1472-6
  • Niven RW, Ip AY, Mittelman SD, et al. Protein nebulization: I. Stability of lactate dehydrogenase and recombinant granulocyte-colony stimulating factor to air-jet nebulization. Int J Pharm 1994;109(1):17-26
  • Agu RU, Ugwoke MI, Armand M, et al. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res 2001;2(4):198-209
  • Waldrep JC, Dhand R. Advanced nebulizer designs employing vibrating mesh/aperture plate technologies for aerosol generation. Curr Drug Deliv 2008;5(2):114-19
  • Pilcer G, Amighi K. Formulation strategy and use of excipients in pulmonary drug delivery. Int J Pharm 2010;392(1-2):1-19
  • Montharu J, Le Guellec S, Kittel B, et al. Evaluation of lung tolerance of ethanol, propylene glycol, and sorbitan monooleate as solvents in medical aerosols. J Aerosol Med Pulm Drug Deliv 2010;23(1):41-6

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