Evaluation of In Vitro Dissolution Consistency of Domestic and Original Finasteride Tablets and Establishment of In Vivo-In Vitro Correlation Model using GastroPlusTM
Keywords:
Finasteride tablet, Dissolution, Consistency evaluation, Computer simulationAbstract
Objective: To evaluate the quality consistency between domestic finasteride tablets and the original reference formulation by comparing their in vitro dissolution behavior, and to analyze the in vitro-in vivo correlation using computer simulation technology. Methods: Following the methods outlined in the 2015 edition of the Chinese Pharmacopoeia (unchanged in the 2020 edition), the in vitro dissolution behavior of the domestic formulations and the reference formulation was examined in four different dissolution media: pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, and water. Additionally, the GastroPlus™ software was used in combination with the in vitro dissolution test results to establish an in vitro-in vivo correlation model for finasteride tablets. Results: Under the selected conditions, products from three out of 15 domestic pharmaceutical companies demonstrated dissolution curves in all four media that were similar to those of the reference formulation. However, software analysis suggested that the in vitro dissolution curves were not consistent with the simulated in vivo behavior. Conclusion: The dissolution curves of most generic finasteride tablets showed certain differences compared to the reference formulation, indicating that the manufacturing processes and formulations of domestic finasteride tablets need improvement. Further research is required to establish biorelevant dissolution conditions that reflect in vivo release behavior.
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