Formulation Development and In-Vitro-In-Vivo Correlation (IVIVC) Level A of Vonoprazan Tablets (20 mg) Using a Convolution-Based Method

Abstract

The present study aimed to develop a 20 mg Vonoprazan tablet formulation and a convolution-based Level A IVIVC model was developed using published in-vivo data. Various hits and trials were done to obtain desired release profiles by changing concentration of super disintegrants, hardness of tablets and dissolution Speeds. High-performance Liquid Chromatography (HPLC) was used to analyze drug concentration. Pharmacokinetic parameters such as Maximum Plasma Drug Concentration (Cmax), Time to reach maximum concentration (Tmax) and Area Under Curve (AUC) were predicted using convolution method based on in-vitro data. The predicted pharmacokinetic parameters: Cmax = 16.61 ng/ml, Tmax = 1.98 hr, and AUC₀–∞ = 187.14 ng·h/ml showed close agreement with observed values Cmax = 18.2 ng/ml, Tmax = 1.98 hr, AUC₀–₂₄ = 160.8 ng·h/ml, AUC₀–∞ = 179.3 ng·h/ml. The %PE for Cmax is 8.74%, AUC₀–∞ is 4.37% and Tmax is 1.0 %. These results demonstrate acceptable correlation for all pharmacokinetics parameters indicating that the developed model has good predictive performance. The developed formulation demonstrated a close correlation between in vitro dissolution and in-vivo absorption profiles, confirming the predictability of the model. This study supports the potential of convolution-based modeling as a reliable approach for formulation optimization and regulatory biowaiver justification.