Polysorbate stability

effects of packaging materials, buffers, counterions, and pH

Blaž Lebar (Author), Tinkara Lekić (Author), Pija Košir (Author), Miha Kastelic (Author), Mitja Zidar (Author), Janez Mravljak (Author), Stane Pajk (Author)

Abstract

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.

Keywords

polysorbates;primary packaging material;hydrolysis;stability;histidine;acetic acid;principal component analysis;

Data

Language:	English
Year of publishing:	2024
Typology:	1.01 - Original Scientific Article
Organization:	UL FFA - Faculty of Pharmacy
UDC:	66.093+544.7
COBISS:	208616195
ISSN:	0378-5173
Views:	63
Downloads:	480
Average score:	0 (0 votes)
Metadata:

Other data

Secondary language:	Slovenian
Secondary keywords:	polisorbati;primarni embalažni material;stabilnost;histidin;ocetna kislina;analiza glavne komponente;Farmacevtska kemija;Hiroliza;Površinska kemija;
Type (COBISS):	Article
Pages:	8 str.
Issue:	ǂVol. ǂ 665
Chronology:	2024
DOI:	10.1016/j.ijpharm.2024.124598
ID:	25151960