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A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation.
J Control Release 2010; 144(2):127-33JC

Abstract

The aim of this study was to investigate two different processes to produce a stable influenza subunit vaccine powder for pulmonary immunization i.e. spray drying (SD) and spray freeze drying (SFD). The formulations were analyzed by proteolytic assay, single radial immunodiffusion assay (SRID), cascade impactor analysis, and immunization studies in Balb/c mice. Proteolytic assay and SRID analysis showed that antigen integrity after SFD was best conserved when the formulation was buffered by Hepes buffer saline (HBS). Surprisingly, antigen integrity after SD was better conserved when the formulation was buffered by phosphate buffer saline (PBS) rather than by HBS. The dispersion from the dry powder inhaler, the Twincer, resulted in a fine particle fraction (aerodynamic particle size <5microm) of 37% and 23% for spray dried and spray freeze dried powders, respectively. Immunogenicity of both vaccine formulations (SFD/HBS and SD/PBS) was similar to conventional liquid formulation after i.m. immunization. In addition, compared to i.m. immunizations, the pulmonary immunization with the dry powders resulted in significantly higher IgG titers. Furthermore, both the formulations remained biochemically and physically stable for at least 3years of storage at 20 degrees C. Our results demonstrate that both optimized formulations are stable and have good inhalation characteristics.

Authors+Show Affiliations

Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, The Netherlands. v.saluja@rug.nl

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20219608

Citation

Saluja, V, et al. "A Comparison Between Spray Drying and Spray Freeze Drying to Produce an Influenza Subunit Vaccine Powder for Inhalation." Journal of Controlled Release : Official Journal of the Controlled Release Society, vol. 144, no. 2, 2010, pp. 127-33.
Saluja V, Amorij JP, Kapteyn JC, et al. A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation. J Control Release. 2010;144(2):127-33.
Saluja, V., Amorij, J. P., Kapteyn, J. C., de Boer, A. H., Frijlink, H. W., & Hinrichs, W. L. (2010). A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation. Journal of Controlled Release : Official Journal of the Controlled Release Society, 144(2), pp. 127-33. doi:10.1016/j.jconrel.2010.02.025.
Saluja V, et al. A Comparison Between Spray Drying and Spray Freeze Drying to Produce an Influenza Subunit Vaccine Powder for Inhalation. J Control Release. 2010 Jun 1;144(2):127-33. PubMed PMID: 20219608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison between spray drying and spray freeze drying to produce an influenza subunit vaccine powder for inhalation. AU - Saluja,V, AU - Amorij,J-P, AU - Kapteyn,J C, AU - de Boer,A H, AU - Frijlink,H W, AU - Hinrichs,W L J, Y1 - 2010/02/25/ PY - 2009/12/23/received PY - 2010/02/17/revised PY - 2010/02/22/accepted PY - 2010/3/12/entrez PY - 2010/3/12/pubmed PY - 2010/9/4/medline SP - 127 EP - 33 JF - Journal of controlled release : official journal of the Controlled Release Society JO - J Control Release VL - 144 IS - 2 N2 - The aim of this study was to investigate two different processes to produce a stable influenza subunit vaccine powder for pulmonary immunization i.e. spray drying (SD) and spray freeze drying (SFD). The formulations were analyzed by proteolytic assay, single radial immunodiffusion assay (SRID), cascade impactor analysis, and immunization studies in Balb/c mice. Proteolytic assay and SRID analysis showed that antigen integrity after SFD was best conserved when the formulation was buffered by Hepes buffer saline (HBS). Surprisingly, antigen integrity after SD was better conserved when the formulation was buffered by phosphate buffer saline (PBS) rather than by HBS. The dispersion from the dry powder inhaler, the Twincer, resulted in a fine particle fraction (aerodynamic particle size <5microm) of 37% and 23% for spray dried and spray freeze dried powders, respectively. Immunogenicity of both vaccine formulations (SFD/HBS and SD/PBS) was similar to conventional liquid formulation after i.m. immunization. In addition, compared to i.m. immunizations, the pulmonary immunization with the dry powders resulted in significantly higher IgG titers. Furthermore, both the formulations remained biochemically and physically stable for at least 3years of storage at 20 degrees C. Our results demonstrate that both optimized formulations are stable and have good inhalation characteristics. SN - 1873-4995 UR - https://www.unboundmedicine.com/medline/citation/20219608/A_comparison_between_spray_drying_and_spray_freeze_drying_to_produce_an_influenza_subunit_vaccine_powder_for_inhalation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-3659(10)00158-6 DB - PRIME DP - Unbound Medicine ER -