Department of Chemical and Biological Engineering, University of Colorado Boulder, Boulder, CO 80303, United States of America.
Department of Chemical and Biological Engineering, University of Colorado Boulder, Boulder, CO 80303, United States of America.
Adv Drug Deliv Rev. 2021 Apr;171:50-61. doi: 10.1016/j.addr.2021.01.016. Epub 2021 Jan 21.
Liquid formulations of vaccines are subject to instabilities that result from degradation processes that proceed via a variety of physical and chemical pathways. In dried formulations, such as those prepared by lyophilization or spray drying, many of these degradation pathways may be avoided or inhibited. Thus, the stability of vaccine formulations can be enhanced significantly in the absence of bulk water. Potential advantages of dry vaccine formulations include extended shelf lives and less stringent cold-chain storage requirements, both of which offer possibilities of reduced vaccine wastage and facilitated distribution to resource-poor areas. Lyophilization and spray drying represent the most common methods of stabilizing vaccines through drying. This article reviews several lyophilized and spray dried vaccines that address a diverse set of pathogens, as well as some of the assays used to quantify their stability. Recent dry vaccine trends include needle-free delivery of dry powder via non-parenteral routes of administration and the incorporation of advanced vaccine adjuvants into formulations, which further contribute to the goal of increasing vaccine distribution to resource-poor areas. Challenges associated with development of these newer technologies are also discussed.
疫苗的液体配方会因为降解过程而变得不稳定，这些降解过程会通过各种物理和化学途径进行。在干燥的配方中，例如通过冷冻干燥或喷雾干燥制备的那些，许多这些降解途径可能会被避免或抑制。因此，在没有大量水的情况下，疫苗配方的稳定性可以显著提高。干燥疫苗配方的潜在优势包括延长的保质期和对冷链储存要求的降低，这两者都为减少疫苗浪费和方便向资源匮乏地区分配提供了可能性。冷冻干燥和喷雾干燥是通过干燥稳定疫苗的最常见方法。本文综述了几种针对不同病原体的冷冻干燥和喷雾干燥疫苗，以及用于量化其稳定性的一些检测方法。最近的干燥疫苗趋势包括通过非肠道途径无针输送干粉，以及将先进的疫苗佐剂纳入配方中，这进一步有助于实现向资源匮乏地区增加疫苗分配的目标。还讨论了开发这些新技术所面临的挑战。
