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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.
Eur J Pharm Biopharm 2013; 85(3 Pt A):716-25EJ

Abstract

One of the advantages of dry influenza vaccines over conventional liquid influenza vaccines is that they can be used for alternative routes of administration. Previous studies showed that spray freeze-drying is an excellent technique to prepare vaccine containing powders for pulmonary delivery (J.P. Amorij, V. Saluja, A.H. Petersen, W.L.J. Hinrichs, A. Huckriede, 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; S.A. Audouy, G. van der Schaaf, W.L.J. Hinrichs, H.W. Frijlink, J. Wilschut, A. Huckriede. Development of a dried influenza whole inactivated virus vaccine for pulmonary immunization, Vaccine (2011)). The aim of this study was to investigate the physical and immunogenic stability of spray freeze-dried whole inactivated virus influenza vaccine prepared by using inulin, dextran, and a mixture of dextran and trehalose as protectants. Physical and biochemical characteristics of the vaccine powder were maintained at temperatures up to 30 °C for 3 months. In addition, in vivo data indicate that also, the immunogenic properties of the vaccine were maintained under these storage conditions. On the other hand, in vivo results also revealed that subtle changes in powder characteristics were induced during storage at 30 °C. However, laser diffraction measurements showed that problems associated with these subtle changes can be overcome by using dry powder inhalers with an efficient powder dispersing capacity.

Authors+Show Affiliations

Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands. Electronic address: s.murugappan@rug.nl.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

23933147

Citation

Murugappan, Senthil, et al. "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 : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 85, no. 3 Pt A, 2013, pp. 716-25.
Murugappan S, Patil HP, Kanojia G, et al. 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. Eur J Pharm Biopharm. 2013;85(3 Pt A):716-25.
Murugappan, S., Patil, H. P., Kanojia, G., ter Veer, W., Meijerhof, T., Frijlink, H. W., ... Hinrichs, W. L. (2013). 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 : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 85(3 Pt A), pp. 716-25. doi:10.1016/j.ejpb.2013.07.018.
Murugappan S, et al. 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. Eur J Pharm Biopharm. 2013;85(3 Pt A):716-25. PubMed PMID: 23933147.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Murugappan,Senthil, AU - Patil,Harshad P, AU - Kanojia,Gaurav, AU - ter Veer,Wouter, AU - Meijerhof,Tjarko, AU - Frijlink,Henderik W, AU - Huckriede,Anke, AU - Hinrichs,Wouter L J, Y1 - 2013/08/08/ PY - 2013/05/07/received PY - 2013/07/29/revised PY - 2013/07/30/accepted PY - 2013/8/13/entrez PY - 2013/8/13/pubmed PY - 2014/9/27/medline KW - Antigen stability KW - Dextran KW - Influenza vaccine KW - Inulin KW - Physical stability KW - Pulmonary powder KW - Trehalose SP - 716 EP - 25 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 85 IS - 3 Pt A N2 - One of the advantages of dry influenza vaccines over conventional liquid influenza vaccines is that they can be used for alternative routes of administration. Previous studies showed that spray freeze-drying is an excellent technique to prepare vaccine containing powders for pulmonary delivery (J.P. Amorij, V. Saluja, A.H. Petersen, W.L.J. Hinrichs, A. Huckriede, 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; S.A. Audouy, G. van der Schaaf, W.L.J. Hinrichs, H.W. Frijlink, J. Wilschut, A. Huckriede. Development of a dried influenza whole inactivated virus vaccine for pulmonary immunization, Vaccine (2011)). The aim of this study was to investigate the physical and immunogenic stability of spray freeze-dried whole inactivated virus influenza vaccine prepared by using inulin, dextran, and a mixture of dextran and trehalose as protectants. Physical and biochemical characteristics of the vaccine powder were maintained at temperatures up to 30 °C for 3 months. In addition, in vivo data indicate that also, the immunogenic properties of the vaccine were maintained under these storage conditions. On the other hand, in vivo results also revealed that subtle changes in powder characteristics were induced during storage at 30 °C. However, laser diffraction measurements showed that problems associated with these subtle changes can be overcome by using dry powder inhalers with an efficient powder dispersing capacity. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/23933147/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(13)00278-6 DB - PRIME DP - Unbound Medicine ER -