Sistematični pregled izsledkov raziskav o razgradnji polisorbatov 20 in 80 v tekočih farmacevtskih oblikah

Terlep, Nika (author), Mravljak, Janez (mentor)

Ozadje: Polisorbati se v farmacevtski industriji uporabljajo za preprečevanje fizičnih poškodb proteinov med različnimi industrijskimi postopki, skladiščenjem in dostavo farmacevtskega izdelka. Pod določenimi pogoji so nagnjeni k razgradnji, kar lahko negativno vpliva na stabilnost, kakovost in varnost izdelka. Namen: Pregledati literaturo in izdelati sistematični pregled izsledkov raziskav oksidativne razgradnje najbolj pogosto uporabljenih polisorbatov (polisorbat 20 in polisorbat 80). Določiti dejavnike oziroma faktorje, ki povzročajo oksidacijo v polisorbatih in razpadne produkte, ki nastanejo pri oksidaciji polisorbatov v tekočih farmacevtskih oblikah ter uporabljene analizne instrumentalne metode za detekcijo in kvantifikacijo razpadnih produktov. Metode: Z uporabo vnaprej določenega iskalnega profila smo v podatkovni bazi PubMed in Web of Science poiskali raziskave, objavljene do konca februarja 2020. Vključili smo raziskave, ki so vrednotile oksidativno razgradnjo polisorbatov 20 in 80 v tekočih farmacevtskih oblikah. Rezultati: V sistematičnem pregledu smo obravnavali 17 raziskav, ki so ustrezale vključitvenim in izključitvenim kriterijem. V objavljeni literaturi smo odkrili kar nekaj povzročiteljev oksidacije v polisorbatih in njihovih razpadnih produktov ter raznolikih analiznih instrumentalnih metod za detekcijo in kvantifikacijo razpadnih produktov.

• Language: Slovenian
• Keywords: polisorbat 20, polisorbat 80, stabilnost, oksidativna razgradnja, razpadni produkti, biofarmacevtska formulacija, proteinska formulacija, tekoča farmacevtska oblika
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2020
• PID: 20.500.12556/RUL-122125
• Publication date in RUL: 25.11.2020

Secondary language

• Language: English
• Title: Systematic review of research results on degradation of polysorbates 20 and 80 in liquid pharmaceutical forms

Abstract

Background: Polysorbates are used in the pharmaceutical industry to prevent physical damage to proteins during various industrial processes, storage and delivery of a pharmaceutical product. Under certain conditions they are susceptible to degradation, which can have a negative impact on the stability, quality and safety of the product. Aim: Review the literature and make a systematic review of the research results on oxidative degradation of the most commonly used polysorbates (Polysorbate 20 and Polysorbate 80). Determine the factors that cause oxidation in polysorbates and the degradation products resulting from the oxidation of polysorbates in liquid pharmaceutical forms. Determine analytical instrumental methods used to detect and quantify degradation products. Methods: Using a predefined search profile, we searched the PubMed and Web of Science databases for research results published by the end of February 2020. We included studies to evaluate the oxidative degradation of the polysorbates 20 and 80 in liquid pharmaceutical forms. Results: In the systematic review, we examined 17 studies that met the inclusion and exclusion criteria. In the published literature we discovered a number of oxidants in polysorbates and their degradation products as well as various instrumental analytical methods for the detection and quantification of degradation products.

• Keywords: polysorbate 20, polysorbate 80, stability, oxidative degradation, degradation products, biopharmaceutical formulation, protein formulation, liquid pharmaceutical form