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Preparation of H1N1 microneedles by a low-temperature process without a stabilizer

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  • Preparation of H1N1 microneedles by a low-temperature process without a stabilizer

    Eur J Pharm Biopharm. 2019 Aug 6. pii: S0939-6411(19)30574-0. doi: 10.1016/j.ejpb.2019.08.005. [Epub ahead of print]
    Preparation of H1N1 microneedles by a low-temperature process without a stabilizer.

    Jeong HR1, Park SH2, Park JH1, Bae JY2, Kim GY2, Baek SK3, Park MS4, Park JH5.
    Author information

    1 Department of Bionano Technology and Gachon BioNano Research Institute, Gachon University, Gyeonggi-do, Republic of Korea. 2 Department of Microbiology, College of Medicine, and the Institute for Viral Diseases, Korea University, Seoul 136-705, Republic of Korea. 3 QuadMedicine R&D Centre, QuadMedicine Co., Ltd, Seongnam, Republic of Korea. 4 Department of Microbiology, College of Medicine, and the Institute for Viral Diseases, Korea University, Seoul 136-705, Republic of Korea. Electronic address: ms0392@korea.ac.kr. 5 Department of Bionano Technology and Gachon BioNano Research Institute, Gachon University, Gyeonggi-do, Republic of Korea. Electronic address: pa90201@gachon.ac.kr.

    Abstract

    During the manufacture of H1N1 microneedles, a stabilizer is usually added to maintain the antigenicity of the vaccine. However, finding a suitable stabilizer is difficult, and the addition of a stabilizer can limit the antigen dose and the addition of an adjuvant because of the limited volume of the microneedles. In this study, the authors evaluated whether H1N1 microneedles could be fabricated without a stabilizer by keeping the production environment at a low temperature. H1N1 microneedle patches without a stabilizer were prepared in a process that involved maintaining a low temperature of 10 C. The protective immune response to this method of drug application was investigated by comparing it with traditional intramuscular (IM) immunization and with the use of H1N1 microneedles with a stabilizer. A process-sensitive antigen, H1N1, was stabilized without the use of a stabilizer in a process that maintained a low temperature of 10 C. The preparation process consisted of coating and drying processes. In animal experiments, mice were immunized using an array of low-temperature H1N1 microneedles without a stabilizer (LT-MN), and they showed strong antibody responses. Compared to three other application methods of traditional IM immunization, low-temperature H1N1 microneedles with a stabilizer (LT-MN-T), and room-temperature H1N1 microneedles with a stabilizer (RT-MN-T), LT-MN produced comparable results in inducing protective immunity. A plaque reduction neutralization test found that LT-MN and LT-MN-T provided greater immunity compared with IM and RT-MN-T. A process in which the temperature is maintained at 10 C can provide successful vaccination with H1N1 microneedles without the addition of a stabilizer. This process can be applied to various temperature-sensitive biologics.
    Copyright 2019 Elsevier B.V. All rights reserved.


    KEYWORDS:

    H1N1; Influenza; Low-temperature process; Microneedles; Stabilizer; Temperature-sensitive

    PMID: 31398438 DOI: 10.1016/j.ejpb.2019.08.005
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