Oxidation of drugs during drug product development : problems and solutions

Gabrič, Alen (author), Hodnik, Žiga (author), Pajk, Stane (author)

Oxidation is the second most common degradation pathway for pharmaceuticals, after hydrolysis. However, in contrast to hydrolysis, oxidation is mechanistically more complex and produces a wider range of degradation products; oxidation is thus harder to control. The propensity of a drug towards oxidation is established during forced degradation studies. However, a more realistic insight into degradation in the solid state can be achieved with accelerated studies of mixtures of drugs and excipients, as the excipients are the most common sources of impurities that have the potential to initiate oxidation of a solid drug product. Based on the results of these studies, critical parameters can be identified and appropriate measures can be taken to avoid the problems that oxidation poses to the quality of a drug product. This article reviews the most common types of oxidation mechanisms, possible sources of reactive oxygen species, and how to minimize the oxidation of a solid drug product based on a well-planned accelerated study.

• Language: English
• Keywords: oxidation, peroxides, impurities, new oxidative stressors, oxidative stress testing
• Work type: Article
• Typology: 1.02 - Review Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2022
• Number of pages: 19 str.
• Numbering: Vol. 14, iss. 2, art. 325
• PID: 20.500.12556/RUL-136994
• UDC: 542.943:615
• ISSN on article: 1999-4923
• DOI: 10.3390/pharmaceutics14020325
• COBISS.SI-ID: 100590851
• Publication date in RUL: 27.05.2022

Record is a part of a journal

• Title: Pharmaceutics
• Shortened title: Pharmaceutics
• Publisher: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.
• Licensing start date: 01.02.2022

Secondary language

• Language: Slovenian
• Keywords: nečistoče, novi oksidativni stresorji, testiranje oksidativnega stresa, peroksidi, zdravila, oksidacija, oksidativni stres

Projects

• Funder: ARRS - Slovenian Research Agency
• Project number: P1-0208
• Name: Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin