Impact of peroxide content in excipients and antioxidants on famotidine oxidative stability

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

Famotidine, a widely used H$_2$-receptor antagonist, exhibits sensitivity to oxidative degradation, particularly in the presence of excipients containing peroxide impurities. This study explores the oxidative stability of famotidine under various storage conditions, with a specific focus on excipients with varying peroxide contents. A stability-indicating liquid chromatography-mass spectrometry (LC-MS) method was developed to identify and quantify famotidine degradation products, providing detailed insights into oxidative pathways. In addition, Zeneth software was employed to predict potential degradation products, and its predictive accuracy was evaluated against experimental findings. Antioxidants, including ascorbic acid, propyl gallate, and ethylenediaminetetraacetic acid (EDTA), were incorporated into compressed compatibility mixtures to assess their effects on peroxide-mediated degradation. While propyl gallate and EDTA consistently reduced peroxide levels and enhanced stability, ascorbic acid unexpectedly acted as a pro-oxidant under stress conditions, accelerating peroxide formation in povidone. These findings provide critical insights into mitigating oxidative degradation in famotidine and other solid dosage forms, emphasizing the importance of selecting appropriate excipients, antioxidants, and predictive tools to ensure product stability.

• Jezik: Angleški jezik
• Ključne besede: peroxides, hydrogen peroxide, famotidine, chemical compounds, Zeneth software
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2025
• Št. strani: Str. 259-272
• Številčenje: Vol. 75, iss. 2
• PID: 20.500.12556/RUL-175770
• UDK: 543.2/.9:615.4:54
• ISSN pri članku: 1846-9558
• DOI: 10.2478/acph-2025-0020
• COBISS.SI-ID: 255015171

Avtorske pravice

Podatek o licenci CC BY-NC-ND 4.0 je naveden na pristajalni strani članka (glej zgoraj izvorni URL). (Datum opombe: 7. 11. 2025)

• Datum objave v RUL: 07.11.2025

Gradivo je del revije

• Naslov: Acta pharmaceutica
• Skrajšan naslov: Acta pharm.
• Založnik: Croatian Pharmaceutical Society
• ISSN: 1846-9558
• COBISS.SI-ID: 3817585

Licence

• Licenca: CC BY-NC-ND 4.0, Creative Commons Priznanje avtorstva-Nekomercialno-Brez predelav 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by-nc-nd/4.0/deed.sl
• Opis: Najbolj omejujoča licenca Creative Commons. Uporabniki lahko prenesejo in delijo delo v nekomercialne namene in ga ne smejo uporabiti za nobene druge namene.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: peroksidi, vodikov peroksid, famotidin, kemične spojine, programska oprema Zeneth, farmacevtska kemija, oksidacija, peroksidi

Projekti

• Financer: ARIS - Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije
• Številka projekta: P1-0208
• Naslov: Farmacevtska kemija: načrtovanje, sinteza in vrednotenje učinkovin

• Financer: Krka d.d.