Oxidation of drugs during drug product development

problems and solutions

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

Povzetek

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.

Ključne besede

nečistoče;novi oksidativni stresorji;testiranje oksidativnega stresa;peroksidi;oxidation;peroxides;impurities;new oxidative stressors;oxidative stress testing;

Podatki

Jezik:	Angleški jezik
Leto izida:	2022
Tipologija:	1.02 - Pregledni znanstveni članek
Organizacija:	UL FFA - Fakulteta za farmacijo
UDK:	542.943:615
COBISS:	100590851
ISSN:	1999-4923
Št. ogledov:	79
Št. prenosov:	20
Ocena:	0 (0 glasov)
Metapodatki:

Ostali podatki

Sekundarni jezik:	Slovenski jezik
Sekundarne ključne besede:	Zdravila;Oksidacija;Oksidativni stres;
Vrsta dela (COBISS):	Članek v reviji
Strani:	str. 1-19
Letnik:	ǂVol. ǂ14
Zvezek:	ǂiss. ǂ2
Čas izdaje:	2022
DOI:	10.3390/pharmaceutics14020325
ID:	15437278