Oxidation of drugs during drug product development : problems and solutions

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

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.

• Jezik: Angleški jezik
• Ključne besede: oxidation, peroxides, impurities, new oxidative stressors, oxidative stress testing
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.02 - Pregledni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2022
• Št. strani: 19 str.
• Številčenje: Vol. 14, iss. 2, art. 325
• PID: 20.500.12556/RUL-136994
• UDK: 542.943:615
• ISSN pri članku: 1999-4923
• DOI: 10.3390/pharmaceutics14020325
• COBISS.SI-ID: 100590851
• Datum objave v RUL: 27.05.2022

Gradivo je del revije

• Naslov: Pharmaceutics
• Skrajšan naslov: Pharmaceutics
• Založnik: MDPI
• ISSN: 1999-4923
• COBISS.SI-ID: 517949977

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
• Začetek licenciranja: 01.02.2022

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: nečistoče, novi oksidativni stresorji, testiranje oksidativnega stresa, peroksidi, zdravila, oksidacija, oksidativni stres

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P1-0208
• Naslov: Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin