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Development of an Orodispersible Film Containing Stabilized Influenza Vaccine

Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars...

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Autores principales: Tian, Yu, Bhide, Yoshita C., Woerdenbag, Herman J., Huckriede, Anke L. W., Frijlink, Henderik W., Hinrichs, Wouter L. J., Visser, J. Carolina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150837/
https://www.ncbi.nlm.nih.gov/pubmed/32182676
http://dx.doi.org/10.3390/pharmaceutics12030245
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author Tian, Yu
Bhide, Yoshita C.
Woerdenbag, Herman J.
Huckriede, Anke L. W.
Frijlink, Henderik W.
Hinrichs, Wouter L. J.
Visser, J. Carolina
author_facet Tian, Yu
Bhide, Yoshita C.
Woerdenbag, Herman J.
Huckriede, Anke L. W.
Frijlink, Henderik W.
Hinrichs, Wouter L. J.
Visser, J. Carolina
author_sort Tian, Yu
collection PubMed
description Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars such as trehalose and pullulan can be employed as stabilizing excipients for the antigens. In this study, first, β-galactosidase was used as a model antigen. Solutions containing β-galactosidase and sugar (trehalose or trehalose/pullulan blends) were pipetted onto plain ODFs and then either air- or vacuum-dried. Subsequently, sugar ratios yielding the highest β-galactosidase stability were used to prepare ODFs containing H5N1 whole inactivated influenza virus vaccine (WIV). The stability of the H5N1 hemagglutinin was assessed by measuring its hemagglutination activity. Overall, various compositions of trehalose and pullulan successfully stabilized β-galactosidase and WIV in ODFs. WIV incorporated in ODFs showed excellent stability even at challenging storage conditions (60 °C/0% relative humidity or 30 °C/56% relative humidity) for 4 weeks. Except for sugars, the polymeric component of ODFs, i.e., hypromellose, possibly improved stability of WIV as well. In conclusion, ODFs may be suitable for delivering of WIV to the oral cavity and can possibly serve as an alternative for injections.
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spelling pubmed-71508372020-04-20 Development of an Orodispersible Film Containing Stabilized Influenza Vaccine Tian, Yu Bhide, Yoshita C. Woerdenbag, Herman J. Huckriede, Anke L. W. Frijlink, Henderik W. Hinrichs, Wouter L. J. Visser, J. Carolina Pharmaceutics Article Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars such as trehalose and pullulan can be employed as stabilizing excipients for the antigens. In this study, first, β-galactosidase was used as a model antigen. Solutions containing β-galactosidase and sugar (trehalose or trehalose/pullulan blends) were pipetted onto plain ODFs and then either air- or vacuum-dried. Subsequently, sugar ratios yielding the highest β-galactosidase stability were used to prepare ODFs containing H5N1 whole inactivated influenza virus vaccine (WIV). The stability of the H5N1 hemagglutinin was assessed by measuring its hemagglutination activity. Overall, various compositions of trehalose and pullulan successfully stabilized β-galactosidase and WIV in ODFs. WIV incorporated in ODFs showed excellent stability even at challenging storage conditions (60 °C/0% relative humidity or 30 °C/56% relative humidity) for 4 weeks. Except for sugars, the polymeric component of ODFs, i.e., hypromellose, possibly improved stability of WIV as well. In conclusion, ODFs may be suitable for delivering of WIV to the oral cavity and can possibly serve as an alternative for injections. MDPI 2020-03-08 /pmc/articles/PMC7150837/ /pubmed/32182676 http://dx.doi.org/10.3390/pharmaceutics12030245 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Tian, Yu
Bhide, Yoshita C.
Woerdenbag, Herman J.
Huckriede, Anke L. W.
Frijlink, Henderik W.
Hinrichs, Wouter L. J.
Visser, J. Carolina
Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title_full Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title_fullStr Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title_full_unstemmed Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title_short Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
title_sort development of an orodispersible film containing stabilized influenza vaccine
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150837/
https://www.ncbi.nlm.nih.gov/pubmed/32182676
http://dx.doi.org/10.3390/pharmaceutics12030245
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