Alcohol-induced dose dumping: A comparative study of marketed formulation of mirabegron tablets by UV and HPLC

The aim of this study is to investigate the potential impact of alcohol consumption on the release profile and dissolution characteristics of Mirabegron tablets by UV and HPLC. The dissolution study of Mirabegron tablets was performed in different media, including 0.1N HCl, 5% alcohol, 20% alcohol and 40% alcohol for 120 minutes. The routine analysis was performed according to the OGD dissolution method in phosphate buffer pH 6.8 for 12hours. Samples were collected at regular intervals and analyzed using UV and HPLC systems. The study indicates that when the amount of alcohol concentration was raised, the drug released was negligibly affected. The results demonstrate that even with the highest concentration of alcohol (40%), no dose dumping occurred within a 2-hour dissolution study. This observation reinforces the stability and controlled release of Mirabegron in the presence of alcohol. Furthermore, the drug displayed 88.92% release within 12hours in a phosphate buffer solution at pH 6.8. This release profile suggests that Mirabegron possesses desirable release kinetics, which is crucial for its therapeutic effectiveness. Hence, it can be concluded that alcohol-induced dose dumping is less likely to occur within the tested alcohol concentrations, providing reassurance for patients on Mirabegron treatment. However, it is crucial to exercise caution when combining alcohol with any medication, considering the potential variability in individual responses to drug interactions.