Mucoadhesive wafers composed of binary polymer blends for sublingual delivery and preservation of protein vaccines

Samuel M. Hanson; Shailbala Singh; Anthony Tabet; K. Jagannadha Sastry; Michael Barry; Chun Wang

doi:10.1016/j.jconrel.2020.12.029

Mucoadhesive wafers composed of binary polymer blends for sublingual delivery and preservation of protein vaccines

Samuel M. Hanson, Shailbala Singh, Anthony Tabet, K. Jagannadha Sastry, Michael Barry, Chun Wang

Biomedical Engineering

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

The objective of this study is to develop a simple biopolymer platform of mucoadhesive wafers that enables effective sublingual delivery and preservation of protein vaccines. The wafers were composed of a series of binary polymer blends of carboxymethylcellulose (CMC) and alginate (ALG). Varying the ratio between CMC and ALG resulted in wafers with different microstructure, mechanical properties, disintegration time, and release kinetics of model compounds. Wafers with high CMC content were highly mucoadhesive to sublingual mucosal tissue and could withstand extensive washing, leading to improved protein permeation into the tissue. On the other hand, wafers with high ALG content were not only mechanically robust, but also able to protect a model enzyme (β-galactosidase) against lyophilization and heat challenge. HIV gp140 protein loaded in wafers of the optimal composition could be stored and transported without cold chain, while maintaining antigen-specific immunogenicity after sublingual vaccination in mice. These findings established that the CMC/ALG binary blend polymer wafers have the potential to improve the sublingual delivery and storage stability of protein-based vaccines.

Original language	English (US)
Pages (from-to)	427-437
Number of pages	11
Journal	Journal of Controlled Release
Volume	330
DOIs	https://doi.org/10.1016/j.jconrel.2020.12.029
State	Published - Feb 10 2021

Bibliographical note

Funding Information:
This work was funded by a grant from the Minnesota Partnership for Biotechnology and Medical Genomics . We thank Dr. Paul Iazzio for kindly providing the porcine sublingual tissue. Parts of this work were carried out in the Characterization Facility, University of Minnesota, which receives partial support from NSF through the MRSEC Program . C.W. dedicates this paper to Prof. Jindřich Kopeček.

Publisher Copyright:
© 2020 Elsevier B.V.

Keywords

Mucoadhesive polymer
Sublingual delivery
Vaccine delivery
Vaccine stabilization

PubMed: MeSH publication types

Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jconrel.2020.12.029

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abstract = "The objective of this study is to develop a simple biopolymer platform of mucoadhesive wafers that enables effective sublingual delivery and preservation of protein vaccines. The wafers were composed of a series of binary polymer blends of carboxymethylcellulose (CMC) and alginate (ALG). Varying the ratio between CMC and ALG resulted in wafers with different microstructure, mechanical properties, disintegration time, and release kinetics of model compounds. Wafers with high CMC content were highly mucoadhesive to sublingual mucosal tissue and could withstand extensive washing, leading to improved protein permeation into the tissue. On the other hand, wafers with high ALG content were not only mechanically robust, but also able to protect a model enzyme (β-galactosidase) against lyophilization and heat challenge. HIV gp140 protein loaded in wafers of the optimal composition could be stored and transported without cold chain, while maintaining antigen-specific immunogenicity after sublingual vaccination in mice. These findings established that the CMC/ALG binary blend polymer wafers have the potential to improve the sublingual delivery and storage stability of protein-based vaccines.",

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note = "Funding Information: This work was funded by a grant from the Minnesota Partnership for Biotechnology and Medical Genomics . We thank Dr. Paul Iazzio for kindly providing the porcine sublingual tissue. Parts of this work were carried out in the Characterization Facility, University of Minnesota, which receives partial support from NSF through the MRSEC Program . C.W. dedicates this paper to Prof. Jind{\v r}ich Kope{\v c}ek. Publisher Copyright: {\textcopyright} 2020 Elsevier B.V.",

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AU - Barry, Michael

AU - Wang, Chun

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N2 - The objective of this study is to develop a simple biopolymer platform of mucoadhesive wafers that enables effective sublingual delivery and preservation of protein vaccines. The wafers were composed of a series of binary polymer blends of carboxymethylcellulose (CMC) and alginate (ALG). Varying the ratio between CMC and ALG resulted in wafers with different microstructure, mechanical properties, disintegration time, and release kinetics of model compounds. Wafers with high CMC content were highly mucoadhesive to sublingual mucosal tissue and could withstand extensive washing, leading to improved protein permeation into the tissue. On the other hand, wafers with high ALG content were not only mechanically robust, but also able to protect a model enzyme (β-galactosidase) against lyophilization and heat challenge. HIV gp140 protein loaded in wafers of the optimal composition could be stored and transported without cold chain, while maintaining antigen-specific immunogenicity after sublingual vaccination in mice. These findings established that the CMC/ALG binary blend polymer wafers have the potential to improve the sublingual delivery and storage stability of protein-based vaccines.

AB - The objective of this study is to develop a simple biopolymer platform of mucoadhesive wafers that enables effective sublingual delivery and preservation of protein vaccines. The wafers were composed of a series of binary polymer blends of carboxymethylcellulose (CMC) and alginate (ALG). Varying the ratio between CMC and ALG resulted in wafers with different microstructure, mechanical properties, disintegration time, and release kinetics of model compounds. Wafers with high CMC content were highly mucoadhesive to sublingual mucosal tissue and could withstand extensive washing, leading to improved protein permeation into the tissue. On the other hand, wafers with high ALG content were not only mechanically robust, but also able to protect a model enzyme (β-galactosidase) against lyophilization and heat challenge. HIV gp140 protein loaded in wafers of the optimal composition could be stored and transported without cold chain, while maintaining antigen-specific immunogenicity after sublingual vaccination in mice. These findings established that the CMC/ALG binary blend polymer wafers have the potential to improve the sublingual delivery and storage stability of protein-based vaccines.

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KW - Vaccine stabilization

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Mucoadhesive wafers composed of binary polymer blends for sublingual delivery and preservation of protein vaccines

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

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