Dieplinger Johanna, Moser Christina, König Gerhard, Pinto Joana T, Paudel Amrit
Research Center for Pharmaceutical Engineering GmbH, 8010 Graz, Austria.
Institute of Process and Particle Engineering, Technical University of Graz, 8010 Graz, Austria.
Pharmaceutics. 2023 Oct 21;15(10):2504. doi: 10.3390/pharmaceutics15102504.
While using saccharides as stabilizers for therapeutic protein drying is common, the mechanisms underlying the stabilization during drying remain largely unexplored. Herein, we investigated the effect of different saccharides, trehalose dihydrate (TD), dextran (DEX), and hydroxypropyl β-cyclodextrins (low substitution-HP and high substitution-HPB), on the relative activities of the enzymes trypsin and catalase during miniaturized drying (MD) or spray drying (SD). For trypsin, the presence of saccharides, especially HP, was beneficial, as it significantly improved the enzyme activity following MD. The HPB preserved trypsin's activity during MD and SD. Adding saccharides during MD did not show a notable improvement in catalase activities. Increasing TD was beneficial during the SD of catalase, as indicated by significantly increased activity. Molecular docking and molecular dynamics simulations oftrypsin with HP or HPB revealed the influence of their substitution on the binding affinity for the enzyme. A higher affinity of HP to bind trypsin and itself was observed during simulations. Experimentally, activity reduction was mainly observed during MD, attributable to the higher droplet temperature during MD than during SD. The activities from the experiments and aggregation propensity from molecular modeling helped elucidate the impact of the size of protein and saccharides on preserving the activity during drying.
虽然使用糖类作为治疗性蛋白质干燥的稳定剂很常见,但干燥过程中稳定作用的潜在机制在很大程度上仍未得到探索。在此,我们研究了不同糖类,即二水海藻糖(TD)、右旋糖酐(DEX)和羟丙基β-环糊精(低取代度-HP和高取代度-HPB),对小型干燥(MD)或喷雾干燥(SD)过程中胰蛋白酶和过氧化氢酶相对活性的影响。对于胰蛋白酶,糖类的存在,尤其是HP,是有益的,因为它在MD后显著提高了酶活性。HPB在MD和SD过程中保持了胰蛋白酶的活性。在MD过程中添加糖类并未使过氧化氢酶活性有显著提高。过氧化氢酶在SD过程中增加TD是有益的,表现为活性显著增加。胰蛋白酶与HP或HPB的分子对接和分子动力学模拟揭示了它们的取代对酶结合亲和力的影响。模拟过程中观察到HP与胰蛋白酶及其自身结合的亲和力更高。在实验中,主要在MD过程中观察到活性降低,这归因于MD过程中的液滴温度高于SD过程。实验得出的活性以及分子建模得出的聚集倾向有助于阐明蛋白质和糖类的大小对干燥过程中保持活性的影响。