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喷雾干燥疫苗的配方和递送技术的进展。

Developments in the formulation and delivery of spray dried vaccines.

机构信息

a Intravacc (Institute for Translational Vaccinology) , Bilthoven , The Netherlands.

b Department of Pharmaceutical Technology and Biopharmacy , University of Groningen , Groningen , The Netherlands.

出版信息

Hum Vaccin Immunother. 2017 Oct 3;13(10):2364-2378. doi: 10.1080/21645515.2017.1356952.

Abstract

Spray drying is a promising method for the stabilization of vaccines, which are usually formulated as liquids. Usually, vaccine stability is improved by spray drying in the presence of a range of excipients. Unlike freeze drying, there is no freezing step involved, thus the damage related to this step is avoided. The edge of spray drying resides in its ability for particles to be engineered to desired requirements, which can be used in various vaccine delivery methods and routes. Although several spray dried vaccines have shown encouraging preclinical results, the number of vaccines that have been tested in clinical trials is limited, indicating a relatively new area of vaccine stabilization and delivery. This article reviews the current status of spray dried vaccine formulations and delivery methods. In particular it discusses the impact of process stresses on vaccine integrity, the application of excipients in spray drying of vaccines, process and formulation optimization strategies based on Design of Experiment approaches as well as opportunities for future application of spray dried vaccine powders for vaccine delivery.

摘要

喷雾干燥是一种有前途的疫苗稳定方法,通常将疫苗配制成液体。通常,通过在一系列赋形剂的存在下喷雾干燥来提高疫苗的稳定性。与冷冻干燥不同,喷雾干燥不涉及冷冻步骤,从而避免了与该步骤相关的损伤。喷雾干燥的优势在于能够将颗粒工程化为所需的要求,可用于各种疫苗输送方法和途径。尽管几种喷雾干燥的疫苗已经显示出令人鼓舞的临床前结果,但在临床试验中测试的疫苗数量有限,这表明疫苗稳定和输送是一个相对较新的领域。本文综述了喷雾干燥疫苗制剂和输送方法的现状。特别是,它讨论了工艺应力对疫苗完整性的影响、赋形剂在疫苗喷雾干燥中的应用、基于实验设计方法的工艺和配方优化策略,以及喷雾干燥疫苗粉末在疫苗输送方面的未来应用机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8369/5647985/b9773bde466f/khvi-13-10-1356952-g001.jpg

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