20.500.12556/RUL-162516 Polysorbate stability effects of packaging materials, buffers, counterions, and pH Polysorbates, widely used excipients in drug formulations, present a stability challenge due to complex degradation processes. This study investigates the hydrolysis of polysorbate (PS) under temperature stress (50 °C), focusing on the impact of primary packaging materials (glass vs. plastic vials), buffers (histidine and acetic acid), counterions (chloride vs. malate), and pH (4–7). Our findings reveal that leachables from plastic vials inhibit PS degradation in both histidine and acetic acid buffers. Kinetic parameters derived from sigmoidal fitting suggest distinct degradation mechanisms for each buffer. Furthermore, the malate counterion with histidine displays inhibitory effects on PS hydrolysis. Principal component analysis was employed to identify key factors. These results highlight the critical role of excipients and packaging in PS stability, providing valuable insights for biopharmaceutical formulation development and a deeper understanding of PS degradation complexities. polysorbates primary packaging material hydrolysis stability histidine acetic acid principal component analysis polisorbati primarni embalažni material stabilnost histidin ocetna kislina analiza glavne komponente farmacevtska kemija hiroliza površinska kemija true false true Angleški jezik Slovenski jezik Članek v reviji 2024-09-25 04:17:59 2024-09-25 11:48:05 2024-09-28 03:40:18 0000-00-00 00:00:00 2024 0 0 8 str. Vol. 665, art. 124598 2024 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 66.093+544.7 0378-5173 10.1016/j.ijpharm.2024.124598 208616195 1-s2.0-S0378517324008329-main.pdf 1-s2.0-S0378517324008329-main.pdf 1 E045714EFF10886C96DA14573F54209E a3fc853556c27446261b28d88b5061077a27d358416cac2bcdfe3b8e499320c9 0d8b0da6-7b24-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=191971 https://www.sciencedirect.com/science/article/pii/S0378517324008329 1 47d140eb-7ae4-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=191861 Fakulteta za farmacijo 0 0 0