Informace o publikaci
Solid phase changes of warfarin in tablets
| Autoři | |
|---|---|
| Rok publikování | 2025 |
| Druh | Konferenční abstrakty |
| Fakulta / Pracoviště MU | |
| Citace | |
| Popis | 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. |