Fabrication of microneedle patches with lyophilized influenza vaccine suspended in organic solvent.

Fabrication of microneedle patches with lyophilized influenza vaccine suspended in organic solvent.
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DOI:
10.1007/s13346-021-00927-4
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发表时间:
2021-04
影响因子:
5.4
通讯作者:
Prausnitz MR
Prausnitz MR
中科院分区:
医学2区
文献类型:
--
作者:
Kim YC;Lee JW;Esser ES;Kalluri H;Joyce JC;Compans RW;Skountzou I;Prausnitz MR

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通过微针贴片进行皮肤疫苗接种可简化免疫接种过程,从而增加疫苗的可及性,促进全球健康。冻干已被广泛用于在储存期间稳定疫苗和其他生物制品,但通常与MN贴片制造工艺不兼容。在这项研究中,我们的目标是开发一种方法,通过在铸造过程中将冻干疫苗悬浮在无水有机溶剂中,在制造过程中将冻干灭活疫苗纳入MN贴片中。使用含有氯仿和聚乙烯吡咯烷酮的铸造配方,冻干流感疫苗在生产和随后在40℃下储存3个月期间保持活性。使用这些MN贴片接种流感疫苗在小鼠模型中产生强烈的免疫反应。这种生产工艺可以使疫苗和其他生物制剂通过冻干稳定,并通过MN贴片给药。
Skin vaccination by microneedle (MN) patch simplifies the immunization process to increase access to vaccines for global health. Lyophilization has been widely used to stabilize vaccines and other biologics during storage, but is generally not compatible with the MN patch manufacturing processes. In this study, our goal was to develop a method to incorporate lyophilized inactivated H1N1 influenza vaccine into MN patches during manufacturing by suspending freeze-dried vaccine in anhydrous organic solvent during the casting process. Using a casting formulation containing chloroform and polyvinylpyrrolidone, lyophilized influenza vaccine maintained activity during manufacturing and subsequent storage for 3 months at 40 C. Influenza vaccination using these MN patches generated strong immune responses in a murine model. This manufacturing process may enable vaccines and other biologics to be stabilized by lyophilization and administered via a MN patch.
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