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Author Notes:

Correspondence: Mark R. Prausnitz, prausnitz@gatech.edu.

We would like to thank Seong-O Choi for providing the pyramidal microneedle master structure and Donna Bondy for administrative support.

Mark Prausnitz is an inventor on patents and has a significant financial interest in a company that is developing microneedle-based products (Micron Biomedical).

This potential conflict of interest has been disclosed and is being managed by Georgia Tech and Emory University.

The final publication is available at Springer via http://dx.doi.org/doi:10.1007/s11095-015-1833-9.

Subjects:

Research Funding:

This work was supported in part by the National Institutes of Health.

The work was carried out at the Center for Drug Design, Development and Delivery and the Institute for Bioengineering and Bioscience at the Georgia Institute of Technology, and at the Emory Vaccine Center.

Keywords:

  • Science & Technology
  • Physical Sciences
  • Life Sciences & Biomedicine
  • Chemistry, Multidisciplinary
  • Pharmacology & Pharmacy
  • Chemistry
  • influenza vaccine immunogenicity
  • microneedle patch
  • thermostability
  • vaccine stability
  • IMMUNE-RESPONSES
  • DELIVERY
  • VIRUS
  • DRUG
  • STABILIZATION
  • SKIN
  • PROTEINS
  • STATE
  • IMMUNOGENICITY
  • TEMPERATURES

Enhanced Stability of Inactivated Influenza Vaccine Encapsulated in Dissolving Microneedle Patches

Tools:

Journal Title:

Pharmaceutical Research

Volume:

Volume 33, Number 4

Publisher:

, Pages 868-878

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Purpose: This study tested the hypothesis that encapsulation of influenza vaccine in microneedle patches increases vaccine stability during storage at elevated temperature. Methods: Whole inactivated influenza virus vaccine (A/Puerto Rico/8/34) was formulated into dissolving microneedle patches and vaccine stability was evaluated by in vitro and in vivo assays of antigenicity and immunogenicity after storage for up to 3 months at 4, 25, 37 and 45°C. Results: While liquid vaccine completely lost potency as determined by hemagglutination (HA) activity within 1-2 weeks outside of refrigeration, vaccine in microneedle patches lost 40-50% HA activity during or shortly after fabrication, but then had no significant additional loss of activity over 3 months of storage, independent of temperature. This level of stability required reduced humidity by packaging with desiccant, but was not affected by presence of oxygen. This finding was consistent with additional stability assays, including antigenicity of the vaccine measured by ELISA, virus particle morphological structure captured by transmission electron microscopy and protective immune responses by immunization of mice in vivo. Conclusions: These data show that inactivated influenza vaccine encapsulated in dissolving microneedle patches has enhanced stability during extended storage at elevated temperatures.

Copyright information:

© Springer Science+Business Media New York 2015

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