Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals
改善生物药稳定性和递送效率的干燥技术最新进展
摘要 (Abstract)
1. J Pharm Investig. 2023;53(1):35-57. doi: 10.1007/s40005-022-00610-x. Epub 2022 Dec 21. Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals. Emami F(#)(1), Keihan Shokooh M(#)(1), Mostafavi Yazdi SJ(#)(2). Author information: (1)College of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. (2)Department of Mechanical Engineering, Kettering University, 1700 University Ave, Flint, MI 48504 USA. (#)Contributed equally BACKGROUND: Most biopharmaceuticals are developed in liquid dosage forms that are less stable than solid forms. To ensure the stability of biopharmaceuticals, it is critical to use an effective drying technique in the presence of an appropriate stabilizing excipient. Various drying techniques are available for this purpose, such as freeze drying or lyophilization, spray drying, spray freeze-drying, supercritical fluid drying, particle replication in nonwetting templates, and fluidized bed drying. AREA COVERED: In this review, we discuss drying technologies and their applications in the production of stable solid-state biopharmaceuticals, providing examples of commercially available products or clinical trial formulations. Alongside this, we also review how different analytical methods may be utilized in the evaluation of aerosol performance and powder characteristics of dried protein powders. Finally, we assess the protein integrity in terms of conformational and physicochemical stability and biological activity. EXPERT OPINION: With the aim of treating either infectious respiratory diseases or systemic disorders, inhaled biopharmaceuticals reduce both therapeutic dose and cost of therapy. Drying methods in the presence of optimized protein/stabilizer combinations, produce solid dosage forms of proteins with greater stability. A suitable drying method was chosen, and the process parameters were optimized based on the route of protein administration. With the ongoing trend of addressing deficiencies in biopharmaceutical production, developing new methods to replace conventional drying methods, and investigating novel excipients for more efficient stabilizing effects, these products have the potential to dominate the pharmaceutical industry in the future. © The Author(s) under exclusive licence to The Korean Society of Pharmaceutical Sciences and Technology 2022, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. DOI: 10.1007/s40005-022-00610-x PMCID: PMC9768793 PMID: 36568503 Conflict of interest statement: Conflict of interestAll authors (F. Emami, M. Keihan Shokooh, and S.J. Mostafavi Yazdi) declare that they have no conflict of interest.
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。