Physical and immunogenic stability of spray freeze-dried influenza vaccine powder for pulmonary delivery: Comparison of inulin, dextran, or a mixture of dextran and trehalose as protectants

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 3 PART A, 2013, Pages 716-725

  Murugappan, Senthil ^a   Patil, Harshad P ^b   Kanojia, Gaurav ^a   Ter Veer, Wouter ^b   Meijerhof, Tjarko ^b   Frijlink, Henderik W ^a   Huckriede, Anke ^b   Hinrichs, Wouter L J ^a  

^a UNIVERSITY OF GRONINGEN   (Netherlands)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

Antigen stability; Dextran; Influenza vaccine; Inulin; Physical stability; Pulmonary powder; Trehalose

Indexed keywords

DEXTRAN; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN G2A; INFLUENZA VACCINE; INULIN; PLACEBO; TREHALOSE; VIRUS ANTIBODY;

ANIMAL EXPERIMENT; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DRUG STORAGE; DRY POWDER; FEMALE; FREEZE DRYING; HEMAGGLUTINATION; HUMORAL IMMUNITY; IMMUNOGENICITY; IMMUNOGLOBULIN BLOOD LEVEL; IN VIVO STUDY; INFLUENZA; INFLUENZA VACCINATION; LASER DIFFRACTION; MOLECULAR STABILITY; MOUSE; NONHUMAN; PARTICLE SIZE; PHYSICAL CHEMISTRY; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; STORAGE TEMPERATURE;

ANTIGEN STABILITY; DEXTRAN; INFLUENZA VACCINE; INULIN; PHYSICAL STABILITY; PULMONARY POWDER; TREHALOSE;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; DEXTRANS; DRUG COMPOUNDING; DRUG STABILITY; DRUG STORAGE; DRY POWDER INHALERS; EXCIPIENTS; FEMALE; FREEZE DRYING; INFLUENZA VACCINES; INULIN; MICE; MICE, INBRED BALB C; POWDERS; TEMPERATURE; TREHALOSE;

EID: 84888365787     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.07.018     Document Type: Article

References (43)

1. Y. Bordon Flu vaccine surplus Nat. Rev. Immunol. 10 2010 pp. 88-88
2. F. Coenen, J.T.B.M. Tolboom, and H.W. Frijlink Stability of influenza sub-unit vaccine: does a couple of days outside the refrigerator matter? Vaccine 24 2006 525 531
3. J.P. Amorij, W.L.J. Hinrichs, H.W. Frijlink, J.C. Wilschut, and A. Huckriede Needle-free influenza vaccination Lancet Infect. Dis. 10 2010 699 711
4. R.J. Cox, K.A. Brokstad, and P. Ogra Influenza virus: immunity and vaccination strategies. comparison of the immune response to inactivated and live, attenuated influenza vaccines Scand. J. Immunol. 59 2004 1 15
5. M.T. Osterholm, N.S. Kelley, A. Sommer, and E.A. Belongia Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis Lancet Infect. Dis. 12 2012 36 44
6. T. Jefferson, C. Di Pietrantonj, L.A. Al-Ansary, E. Ferroni, S. Thorning, and R.E. Thomas Vaccines for preventing influenza in the elderly Cochrane Database Syst. Rev. 2 2010 CD004876
7. E. Greenbaum, D. Engelhard, R. Levy, M. Schlezinger, A. Morag, and Z. Zakay-Rones Mucosal (SIgA) and serum (IgG) immunologic responses in young adults following intranasal administration of one or two doses of inactivated, trivalent anti-influenza vaccine Vaccine 22 2004 2566 2577
8. R.L. Atmar, W.A. Keitel, T.R. Cate, F.M. Munoz, F. Ruben, and R.B. Couch A dose-response evaluation of inactivated influenza vaccine given intranasally and intramuscularly to healthy young adults Vaccine 25 2007 5367 5373
9. R. Waldman, J. Mann, and P.A. Small Immunization against influenza: prevention of illness in man by aerosolized inactivated vaccine JAMA 207 1969 520 524
10. W. Haigh, and R.W. Howell The efficacy of the A2/Aichi/68 strain in inhaled influenza immunisation against the A/England/42/72 variant J. Soc. Occup. Med. 23 1973 125 127
11. J. Holmgren, C. Czerkinsky, N. Lycke, and A. Svennerholm Mucosal immunity: implications for vaccine development Immunobiology 184 1992 157 179
12. H.W. Frijlink, and A.H. de Boer Trends in the technology-driven development of new inhalation devices Drug Discov. Today Technol. 2 2005 47 57
13. W. Wang Lyophilization and development of solid protein pharmaceuticals Int. J. Pharm. 203 2000 1 60
14. D. Greiff, W.A. Rightsel, and E.E. Schuler Effects of freezing, storage at low temperatures, and drying by sublimation in vacuo on the activities of measles virus Nature 202 1964 624 625
15. J. Huang, R.J. Garmise, T.M. Crowder, K. Mar, C.R. Hwang, A.J. Hickey, J.A. Mikszta, and V.J. Sullivan A novel dry powder influenza vaccine and intranasal delivery technology: induction of systemic and mucosal immune responses in rats Vaccine 23 2004 794 801
16. Y. Maa, M. Ameri, C. Shu, L.G. Payne, and D. Chen Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation J. Pharm. Sci. 93 2004 1912 1923
17. J.P. Amorij, J. Meulenaar, W.L.J. Hinrichs, T. Stegmann, A. Huckriede, F. Coenen, and H.W. Frijlink Rational design of an influenza subunit vaccine powder with sugar glass technology: preventing conformational changes of haemagglutinin during freezing and freeze-drying Vaccine 25 2007 6447 6457
18. J. de Jonge, J.P. Amorij, W.L.J. Hinrichs, J. Wilschut, A. Huckriede, and H.W. Frijlink Inulin sugar glasses preserve the structural integrity and biological activity of influenza virosomes during freeze-drying and storage Eur. J. Pharm. Sci. 32 2007 33 44
19. F. Geeraedts, V. Saluja, W. ter Veer, J.P. Amorij, H.W. Frijlink, J. Wilschut, W.L.J. Hinrichs, and A. Huckriede Preservation of the immunogenicity of dry-powder influenza H5N1 whole inactivated virus vaccine at elevated storage temperatures AAPS J. 12 2010 215 222
20. F. Geeraedts, L. Bungener, J. Pool, W. ter Veer, J. Wilschut, and A. Huckriede Whole inactivated virus influenza vaccine is superior to subunit vaccine in inducing immune responses and secretion of proinflammatory cytokines by DCs Influenza Other Respi. Viruses 2 2008 41 51
21. F. Geeraedts, W. ter Veer, J. Wilschut, A. Huckriede, and A. de Haan Effect of viral membrane fusion activity on antibody induction by influenza H5N1 whole inactivated virus vaccine Vaccine 30 2012 6501 6507
22. N. Hagenaars, E. Mastrobattista, H. Glansbeek, J. Heldens, H. van den Bosch, V. Schijns, D. Betbeder, H. Vromans, and W. Jiskoot Head-to-head comparison of four nonadjuvanted inactivated cell culture-derived influenza vaccines: effect of composition, spatial organization and immunization route on the immunogenicity in a murine challenge model Vaccine 26 2008 6555 6563
23. A. Hovden, R.J. Cox, and L.R. Haaheim Whole influenza virus vaccine is more immunogenic than split influenza virus vaccine and induces primarily an IgG2a response in BALB/c mice Scand. J. Immunol. 62 2005 36 44
24. P. Zanen, L.T. Go, and J.J. Lammers The optimal particle size for β-adrenergic aerosols in mild asthmatics Int. J. Pharm. 107 1994 211 217
25. E.M. Westerman, H.G. Heijerman, and H.W. Frijlink Dry powder inhalation versus wet nebulisation delivery of antibiotics in cystic fibrosis patients Exp. Opin. Drug Deliv. 4 2007 91 94
26. J.P. Amorij, V. Saluja, A.H. Petersen, W.L.J. Hinrichs, A. Huckriede, and H.W. Frijlink Pulmonary delivery of an inulin-stabilized influenza subunit vaccine prepared by spray-freeze drying induces systemic, mucosal humoral as well as cell-mediated immune responses in BALB/c mice Vaccine 25 2007 8707 8717
27. S.A. Audouy, G. van der Schaaf, W.L.J. Hinrichs, H.W. Frijlink, J. Wilschut, and A. Huckriede Development of a dried influenza whole inactivated virus vaccine for pulmonary immunization Vaccine 2011
28. M.G. Fakes, M.V. Dali, T.A. Haby, K.R. Morris, S.A. Varia, and A.T.M. Serajuddin Moisture sorption behavior of selected bulking agents used in lyophilized products PDA J. Pharm. Sci. Technol. 54 3/4 2000 144 149
29. O. Gloger, K. Witthohn, and B.W. Müller Lyoprotection of aviscumine with low molecular weight dextrans Int. J. Pharm. 260 2003 59 68
30. S.D. Allison, M.C. Manning, T.W. Randolph, K. Middleton, A. Davis, and J.F. Carpenter Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran J. Pharm. Sci. 89 2000 199 214
31. J. Carpenter, M. Pikal, B. Chang, and T. Randolph Rational design of stable lyophilized protein formulations: some practical advice Pharm. Res. 14 1997 969 975
32. M.J. Pikal, D.R. Rigsbee, and M.L. Roy Solid state chemistry of proteins: I. Glass transition behavior in freeze dried disaccharide formulations of human growth hormone (hGH) J. Pharm. Sci. 96 2007 2765 2776
33. J.P. Amorij, J. Meulenaar, W.L.J. Hinrichs, T. Stegmann, A. Huckriede, F. Coenen, and H.W. Frijlink Rational design of an influenza subunit vaccine powder with sugar glass technology: preventing conformational changes of haemagglutinin during freezing and freeze-drying Vaccine 25 2007 6447 6457
34. D.E. Gardner, and D.T. Kirkpatrick Respiratory tract Philip Wexler, Encyclopedia of Toxicology second ed. 2005 Elsevier New York 665 698
35. G.S. Zijlstra, M. Rijkeboer, D.J. Drooge, M. Sutter, W. Jiskoot, M. Weert, W.L.J. Hinrichs, and H.W. Frijlink Characterization of a cyclosporine solid dispersion for inhalation AAPS J. 9 2007 E190 E199
36. C. Duret, N. Wauthoz, R. Merlos, J. Goole, C. Maris, I. Roland, T. Sebti, F. Vanderbist, and K. Amighi In vitro and in vivo evaluation of a dry powder endotracheal insufflator device for use in dose-dependent preclinical studies in mice Eur. J. Pharm. Biopharm. 81 2012 627 634
37. F. Geeraedts, N. Goutagny, V. Hornung, M. Severa, A. de Haan, J. Pool, J. Wilschut, K. Fitzgerald, and A. Huckriede Superior immunogenicity of inactivated whole virus H5N1 influenza vaccine is primarily controlled by toll-like receptor signalling PLoS Pathog. 8 2008 e1000138
38. W.L.J. Hinrichs, M.G. Prinsen, and H.W. Frijlink Inulin glasses for the stabilization of therapeutic proteins Int. J. Pharm. 215 2001 163 174
39. S. Jaffari, B. Forbes, E. Collins, D. Barlow, G.P. Martin, and D. Murnane Rapid characterisation of the inherent dispersibility of respirable powders using dry dispersion laser diffraction Int. J. Pharm. 447 2013 124 131
40. V. Saluja, J.P. Amorij, J.C. Kapteyn, A.H. de Boer, H.W. Frijlink, and W.L.J. Hinrichs A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation J. Control. Release 144 2010 127 133
41. A.H. de Boer, P.P.H. Le Brun, H.G. van der Woude, P. Hagedoorn, H.G.M. Heijerman, and H.W. Frijlink Dry powder inhalation of antibiotics in cystic fibrosis therapy, Part 1: Development of a powder formulation with colistin sulfate for a special test inhaler with an air classifier as de-agglomeration principle Eur. J. Pharm. Biopharm. 54 2002 17 24
42. C. Fenton, G.M. Keating, and G.L. Plosker Novolizer: a multidose dry powder inhaler Drugs 63 2003 2437 2445 discussion 2447-8
43. C. Friebel, and H. Steckel Single-use disposable dry powder inhalers for pulmonary drug delivery Exp. Opin. Drug Deliv. 7 2010 1359 1372