2025
Solid phase changes of warfarin in tablets
MUSELÍK, Jan; Martina ČUBOVÁ URBANOVÁ; Aleš FRANC; David VETCHÝ; Jiří BRUS et al.Základní údaje
Originální název
Solid phase changes of warfarin in tablets
Autoři
Vydání
53. Konference Syntéza a analýza léčiv, 2025
Další údaje
Jazyk
angličtina
Typ výsledku
Konferenční abstrakt
Obor
30104 Pharmacology and pharmacy
Utajení
není předmětem státního či obchodního tajemství
Označené pro přenos do RIV
Ne
Organizační jednotka
Farmaceutická fakulta
ISBN
978-80-280-0773-7
Klíčová slova anglicky
solid-state NMR; warafarin; stability; generic substitution
Změněno: 29. 9. 2025 12:45, doc. Mgr. Jan Muselík, Ph.D.
Anotace
V originále
This study aimed to evaluate the potential influence of interactions between the active pharmaceutical ingredient (API) and commonly used excipients on the safety of generic replacement of warfarin sodium tablets. Changes in the solid phase of warfarin were monitored during the accelerated stability study using solid-state NMR spectroscopy and dissolution tests. Tablets containing crystalline or amorphous sodium warfarin were prepared for the study, and commercial warfarin tablets were also used for comparative analysis. During the stability study, the conversion of the warfarin sodium salt to its acidic form through interaction with certain excipients was demonstrated. This solid-phase transformation of warfarin leads to significant changes in the dissolution profile, especially at different API particle sizes in the tablet. Therefore, the choice of appropriate excipients and API particle size are critical factors influencing the safety of generic warfarin sodium.
Návaznosti
| LTAUSA18011, projekt VaV |
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