Polysorbate stability : effects of packaging materials, buffers, counterions, and pH

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

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.

• Jezik: Angleški jezik
• Ključne besede: polysorbates, primary packaging material, hydrolysis, stability, histidine, acetic acid, principal component analysis
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2024
• Št. strani: 8 str.
• Številčenje: Vol. 665, art. 124598
• PID: 20.500.12556/RUL-162516
• UDK: 66.093+544.7
• ISSN pri članku: 0378-5173
• DOI: 10.1016/j.ijpharm.2024.124598
• COBISS.SI-ID: 208616195
• Datum objave v RUL: 25.09.2024

Gradivo je del revije

• Naslov: International journal of pharmaceutics
• Skrajšan naslov: Int. j. pharm.
• Založnik: Elsevier
• ISSN: 0378-5173
• COBISS.SI-ID: 3087631

Licence

• Licenca: CC BY-NC 4.0, Creative Commons Priznanje avtorstva-Nekomercialno 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by-nc/4.0/deed.sl
• Opis: Licenca Creative Commons, ki prepoveduje komercialno uporabo, vendar uporabniki ne rabijo upravljati materialnih avtorskih pravic na izpeljanih delih z enako licenco.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: polisorbati, primarni embalažni material, stabilnost, histidin, ocetna kislina, analiza glavne komponente, farmacevtska kemija, hiroliza, površinska kemija

Projekti

• Financer: Drugi - Drug financer ali več financerjev
• Program financ.: Novartis Pharmaceutical Manufacturing LLC

• Financer: ARIS - Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije
• Številka projekta: P1-0208
• Naslov: Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin