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  • Oxidation of drugs during drug product development [Elektronski vir] : problems and solutions
    Gabrič, Alen ; Hodnik, Žiga, farmacevt ; Pajk, Stane, 1983-
    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.
    Source: Pharmaceutics [Elektronski vir]. - ISSN 1999-4923 (Vol. 14, iss. 2, 2022, str. 1-19)
    Type of material - e-article ; adult, serious
    Publish date - 2022
    Language - english
    COBISS.SI-ID - 100590851

    Link(s):

    https://www.mdpi.com/1999-4923/14/2/325
    Repository of the University of Ljubljana – RUL
    DOI

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