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Structural changes of sodium warfarin in tablets affecting the dissolution profiles and potential safety of generic substitution
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SYSNO ASEP 0545620 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS Název Structural changes of sodium warfarin in tablets affecting the dissolution profiles and potential safety of generic substitution Tvůrce(i) Muselík, J. (CZ)
Urbanová, Martina (UMCH-V) RID, ORCID
Bartoníčková, E. (CZ)
Palovčík, J. (CZ)
Vetchý, D. (CZ)
Czernek, Jiří (UMCH-V) RID
Janisova, Larisa (UMCH-V) RID, ORCID
Velychkivska, Nadiia (UMCH-V) RID, ORCID
Franc, A. (CZ)
Brus, Jiří (UMCH-V) RID, ORCIDČíslo článku 1364 Zdroj.dok. Pharmaceutics. - : MDPI
Roč. 13, č. 9 (2021)Poč.str. 19 s. Jazyk dok. eng - angličtina Země vyd. CH - Švýcarsko Klíč. slova warfarin ; solid-state NMR ; polymorphism Vědní obor RIV CF - Fyzikální chemie a teoretická chemie Obor OECD Physical chemistry CEP LTAUSA18011 GA MŠMT - Ministerstvo školství, mládeže a tělovýchovy Výzkumná infrastruktura e-INFRA CZ - 90140 - CESNET, zájmové sdružení právnických osob
ELIXIR-CZ - 90047 - Ústav organické chemie a biochemie AV ČR, v. v. i.Způsob publikování Open access Institucionální podpora UMCH-V - RVO:61389013 UT WOS 000701490900001 EID SCOPUS 85114262641 DOI 10.3390/pharmaceutics13091364 Anotace At present, the risk of generic substitutions in warfarin tablets is still being discussed. The aim of this study was to assess whether API interactions with commonly used excipients may affect the safety of generic replacement of warfarin sodium tablets. These interactions were observed during an accelerated stability study, and the effect of the warfarin solid phase (crystalline/amorphous form) as well as the API particle size distribution was studied. Commercial tablets and prepared tablets containing crystalline warfarin or amorphous warfarin were used. In addition, binary mixtures of warfarin with various excipients were prepared. The structural changes before and after the stability study were monitored by dissolution test in different media, solid-state NMR spectroscopy and Raman microscopy. During the stability study, the conversion of the sodium in warfarin to its acid form was demonstrated by some excipients (e.g., calcium phosphate). This change in the solid phase of warfarin leads to significant changes in dissolution, especially with the different particle sizes of the APIs in the tablet. Thus, the choice of suitable excipients and particle sizes are critical factors influencing the safety of generic warfarin sodium tablets. Pracoviště Ústav makromolekulární chemie Kontakt Eva Čechová, cechova@imc.cas.cz ; Tel.: 296 809 358 Rok sběru 2022 Elektronická adresa https://www.mdpi.com/1999-4923/13/9/1364
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