20.500.12556/RUL-136994 Oxidation of drugs during drug product development problems and solutions 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. oxidation peroxides impurities new oxidative stressors oxidative stress testing nečistoče novi oksidativni stresorji testiranje oksidativnega stresa peroksidi zdravila oksidacija oksidativni stres true false true Angleški jezik Slovenski jezik Članek v reviji 2022-05-27 13:05:58 2022-05-27 13:06:01 2022-09-15 04:14:34 0000-00-00 00:00:00 2022 0 0 19 str. iss. 2, art. 325 Vol. 14 2022 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 542.943:615 1999-4923 10.3390/pharmaceutics14020325 100590851 pharmaceutics-14-00325.pdf pharmaceutics-14-00325.pdf 1 D229AF12DCF58E3F810422567FDE54AD 37f659093a243fb808587f1ec26762aa3378cc975f7de9e1c31fc1a20a1de000 0e1b6481-ddad-11ec-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=156834 https://www.mdpi.com/1999-4923/14/2/325 1 db89d2bf-ddac-11ec-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=156833 Fakulteta za farmacijo 0 0 0