That's cool! - Nebulization of thermolabile proteins with a cooled vibrating mesh nebulizer

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 87, Issue 2, 2014, Pages 357-365

  Hertel, Sebastian ^a   Pohl, Thomas ^b   Friess, Wolfgang ^a   Winter, Gerhard ^a  

^a UNIVERSITY OF MUNICH   (Germany)

^b SuppreMol GmbH   (Germany)

Author keywords

Active cooling; Fc RIIB; IgG; LDH; Nebulizer performance; PARI eFlow ; Protein stability; Vibrating mesh nebulization

Indexed keywords

IMMUNOGLOBULIN G1; LACTATE DEHYDROGENASE; MONOCLONAL ANTIBODY; PROTEIN DERIVATIVE; PROTEIN SM101; UNCLASSIFIED DRUG; AEROSOL; FC RECEPTOR; FCGR3B PROTEIN, HUMAN; GLYCOSYLPHOSPHATIDYLINOSITOL ANCHORED PROTEIN;

AEROSOL; ARTICLE; COOLING; HEATING; MEDICAL NEBULIZER; NEBULIZATION; PROTEIN AGGREGATION; PROTEIN STABILITY; TEMPERATURE STRESS; THERMOSTABILITY; VIBRATING MESH NEBULIZER; ANIMAL; CHEMISTRY; COLD; DEVICES; DRUG DELIVERY SYSTEM; EQUIPMENT DESIGN; HUMAN; INHALATIONAL DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; NEBULIZER; PHARMACEUTICS; PROCEDURES; PROTEIN CONFORMATION; PROTEIN DENATURATION; RABBIT; TIME; VIBRATION;

ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; CHEMISTRY, PHARMACEUTICAL; COLD TEMPERATURE; DRUG DELIVERY SYSTEMS; EQUIPMENT DESIGN; GPI-LINKED PROTEINS; HUMANS; LACTATE DEHYDROGENASES; NEBULIZERS AND VAPORIZERS; PROTEIN CONFORMATION; PROTEIN DENATURATION; PROTEIN STABILITY; RABBITS; RECEPTORS, IGG; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; VIBRATION;

EID: 84902381555     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2014.03.001     Document Type: Article

References (36)

1. A. Maillet, N. Congy-Jolivet, S. Le Guellec, L. Vecellio, S. Hamard, Y. Courty, A. Courtois, F. Gauthier, P. Diot, G. Thibault, E. Lemarié, and N. Heuzé-Vourc'h Aerodynamical, immunological and pharmacological properties of the anticancer antibody cetuximab following nebulization Pharm. Res. 25 2008 1318 1326
2. P. Brand, M. Schulte, M. Wencker, C.H. Herpich, G. Klein, K. Hanna, and T. Meyer Lung deposition of inhaled α1-proteinase inhibitor in cystic fibrosis and α1-antitrypsin deficiency Eur. Respir. J. 34 2009 354 360
3. M. Luisetti, P. Kroneberg, T. Suzuki, Z. Kadija, B. Muellinger, I. Campo, J. Gleske, G. Rodi, W.C. Zimlich, F. Mariani, F. Ferrari, M. Frey, and B.C. Trapnell Physical properties, lung deposition modeling, and bioactivity of recombinant GM-CSF aerosolised with a highly efficient nebulizer Pulm. Pharmacol. Ther. 24 2011 123 127
4. K.T. Diaz, S. Skaria, K. Harris, M. Solomita, S. Lau, K. Bauer, G.C. Smaldone, and R. Condos Delivery and safety of inhaled interferon-γ in idiopathic pulmonary fibrosis J. Aerosol Med. Pulm. Drug Deliv. 25 2012 79 87
5. T. Scherer, D.E. Geller, L. Owyang, M. Tservistas, M. Keller, N. Boden, K.C. Kesser, and S.J. Shire A technical feasibility study of dornase alfa delivery with eflow® vibrating membrane nebulizers: aerosol characteristics and physicochemical stability J. Pharm. Sci. 100 2011 98 109
6. M. Beck-Broichsitter, P. Kleimann, T. Schmehl, T. Betz, U. Bakowsky, T. Kissel, and W. Seeger Impact of lyoprotectants for the stabilization of biodegradable nanoparticles on the performance of air-jet, ultrasonic, and vibrating-mesh nebulizers Eur. J. Pharm. Biopharm. 82 2012 272 280
7. J.C. Waldrep, and R. Dhand Advanced nebulizer designs employing vibrating mesh/aperture plate technologies for aerosol generation Curr. Drug Deliv. 5 2008 114 119
8. R. Siekmeier, and G. Scheuch Systemic treatment by inhalation of macromolecules - principles, problems and examples J. Physiol. Pharmacol. 59 2008 12
9. M. Knoch, and M. Keller The customised electronic nebuliser: a new category of liquid aerosol drug delivery systems Expert Opinion Drug Deliv. 2 2005 377 390
10. A.B. Watts, J.T. McConville, and R.O. Williams Current therapies and technological advances in aqueous aerosol drug delivery Drug Dev. Ind. Pharm. 34 2008 913 922
11. A.L. Coates, M. Green, K. Leung, J. Chan, N. Ribeiro, F. Ratjen, and M. Charron A comparison of amount and speed of deposition between the PARI LC STAR® jet nebulizer and an investigational eFlow® nebulizer J. Aerosol Med. Pulm. Drug Deliv. 24 2011 157 163
12. S. Tiemersma, S. Minocchieri, R.A. van Lingen, M. Nelle, and S.G. Devadason Vibrating membrane devices deliver aerosols more efficient than standard devices: a study in a neonatal upper airway model J. Aerosol Med. Pulm. Drug Deliv. 26 2013 280 286
13. J.S. Lass, A. Sant, and M. Knoch New advances in aerosolised drug delivery: vibrating membrane nebuliser technology Expert Opinion Drug Deliv. 3 2006 693 702
14. J.B. Fink, D. Schmidt, J. Power, Comparison of a nebulizer using a novel aerosol generator with a standard ultrasonic nebulizer designed for use during mechanical ventilation, in: American Thoracic Society 97th International Conference, San Fransisco, CA, 2001.
15. J.G. Barnard, K. Babcock, and J.F. Carpenter Characterization and quantitation of aggregates and particles in interferon-beta products: potential links between product quality attributes and immunogenicity J. Pharm. Sci. 102 2013 915 928
16. A. Rosenberg Effects of protein aggregates: an immunologic perspective AAPS J. 8 2006 E501 E507
17. R.W. Niven, A.Y. Ip, S. Mittelman, S.J. Prestrelski, and T. Arakawa Some factors associated with the ultrasonic nebulization of proteins Pharm. Res. 12 1995 53 59
18. R.W. Niven, A.Y. Ip, S.D. Mittelman, C. Farrar, T. Arakawa, and S.J. Prestrelski Protein nebulization: I. Stability of lactate dehydrogenase and recombinant granulocyte-colony stimulating factor to air-jet nebulization Int. J. Pharm. 109 1994 17 26
19. T.S. Konstaninova, I.V. Leonidovna, A. Hellmann, S. Kyrcz-Krzemien, S. Tillmanns, P. Sondermann, P. Buckel, Interim Results From a Phase Ib/IIa Clinical Trial with the Soluble Fc-Gamma IIb Receptor SM101 for the Treatment of Primary Immune Thrombocytopenia, in: A.S.o.H. (ASH) (Ed.), 2012 ASH Annual Meeting and Exposition, Atlanta, GA, 2012.
20. S.P. Hertel, W. Friess, G. Winter, Comparison of Aerosol Collection Methods for Liquid Protein Formulations, in: R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman, P.M. Young (Eds.), RDD Europe 2011, Berlin, 2011, pp. 345-350.
21. R. Tandon, M. McPeck, and G.C. Smaldone Measuring nebulizer output aerosol production vs gravimetric analysis CHEST J. 111 1997 1361 1365
22. R.L. Chatburn, and M. McPeck A new system for understanding nebulizer performance Resp. Care 52 2007 1037 1050
23. S. Seemann, M. Hug, R. Uchtirlghagen, A. Schmitt, M. Tservistas, R. Waldner, M. Knoch, Improving aerosol drug delivery in CF therapy, in: 28th European Cystic Fibrosis Conference, Crete, Greece, 2005.
24. L. Vecellio The mesh nebuliser: a recent technical innovation for aerosol delivery Breathe 2 2006 252 260
25. H. Steckel, F. Eskandar, and K. Witthohn The effect of formulation variables on the stability of nebulized aviscumine Int. J. Pharm. 257 2003 181 194
26. A.Y. Ip, T. Arakawa, H. Silvers, C.M. Ransone, and R.W. Niven Stability of recombinant consensus interferon to air-jet and ultrasonic nebulization J. Pharm. Sci. 84 1995 1210 1214
27. Z.M. Corden, C.M. Bosley, P.J. Rees, and G.M. Cochrane Home nebulized therapy for patients with COPD patient compliance with treatment and its relation to quality of life CHEST J. 112 1997 1278 1282
28. G. Scheuch, M.J. Kohlhaeufl, P. Brand, and R. Siekmeier Clinical perspectives on pulmonary systemic and macromolecular delivery Adv. Drug Deliv. Rev. 58 2006 996 1008
29. T. Ghazanfari, A.M.A. Elhissi, Z. Ding, and K.M.G. Taylor The influence of fluid physicochemical properties on vibrating-mesh nebulization Int. J. Pharm. 339 2007 103 111
30. F.-C. Lintz, E. Walther, R. Waldner, M. Keller, Influence of viscosity and surface tension on the nebulization efficiency of a jet (LC PLUS) and a vibrating membrane type nebulizer (e-Flow), in: AAPS Annual Meeting, Denver, 2001.
31. E.N.d.C. Andrade XLI. A theory of the viscosity of liquids - Part I Philos. Mag. Ser. 7 17 1934 497 511
32. K. Schmid, C. Arpagaus, and W. Friess Evaluation of the Nano Spray Dryer B-90 for pharmaceutical applications Pharm. Dev. Technol. 16 2011 287 294
33. T. Serno, E. Hartl, A. Besheer, R. Miller, and G. Winter The role of polysorbate 80 and HPbetaCD at the air-water interface of IgG solutions Pharm. Res. 30 2013 117 130
34. M. Zeles-Hahn, T.J. Anchordoquy, C.S. Lengsfeld, Observations on the impact of aerosolization on macromolecular therapeutics, in: European Conference on Liquid Atomization and Spray Systems, Como Lake, Italy, 2008, pp. 8-13.
35. R.W. Niven, S.J. Prestrelski, M.J. Treuheit, A.Y. Ip, and T. Arakawa Protein nebulization II. Stabilization of G-CSF to air-jet nebulization and the role of protectants Int. J. Pharm. 127 1996 191 201
36. S.P. Hertel, T. Pohl, W. Friess, G. Winter, Prediction of protein degradation during vibrating mesh nebulization via a high throughput screening method, Eur. J. Pharm. Biopharm. 87 (2014) 386-394.