Effect of Buffer Salts on Physical Stability of Lyophilized and Spray-Dried Protein Formulations Containing Bovine Serum Albumin and Trehalose
缓冲盐对含有牛血清白蛋白和海藻糖的冻干和喷雾干燥蛋白质制剂物理稳定性的影响
摘要 (Abstract)
1. Pharm Res. 2024 Feb;41(2):405-406. doi: 10.1007/s11095-023-03639-1. Correction: Effect of Buffer Salts on Physical Stability of Lyophilized and Spray-Dried Protein Formulations Containing Bovine Serum Albumin and Trehalose. Mutukuri TT(1), Ling J(2), Du Y(3), Su Y(4), Zhou QT(5). Author information: (1)Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA. (2)Discovery Pharmaceutical Sciences, Merck & Co., Inc., South San Francisco, California, 94080, USA. (3)Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey, 07065, USA. (4)Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey, 07065, USA. yongchao.su@merck.com. (5)Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA. tonyzhou@purdue.edu. Erratum for Pharm Res. 2023 Jun;40(6):1355-1371. doi: 10.1007/s11095-022-03318-7. DOI: 10.1007/s11095-023-03639-1 PMID: 38158504
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。