In vitro-in vivo correlation(IVIVC) study for ibuprofen liquisolid tablet using a convolution-based modeling approach.

Abstract

This study aimed to develop an in vitro-in vivo procedure for ibuprofen liquisolid tablet and evaluate its predictability via in vivo outcome of a bioequivalence study. By varying the excipient ratio (R), we prepared different batches of ibuprofen liquisolid (LS) tablets and subjected them to pre and post compression studies to select the optimized formulation, after which we compared and investigated the predicted plasma concentration-time profiles of ibuprofen prototype drug from in vitro dissolution results using mathematical convolution approach for In vitro-in vivo correlation (IVIVC) study. Compatibility studies using Fourier transform infra-red (FTIR) and differential scanning calorimetry (DSC) returned no major interactions between the drug and excipients. All formulations demonstrated acceptable flow properties. Tablet weight variations were insignificant, while assay and friability testing were within compendial specifications. Formulation F16 was nearest to the reference brand (Nurofen tablet^® ; Reckitt Benckiser, UK) at every dissolution sampling time hence it was chosen as the optimal formula. Area Under the Curve (AUC) percentage predicted errors were similar for both the test and reference product, while their peak plasma concentration (C_max) deviates by +6.73 and -1.77 percent from the authentic reference values derived from the literature. The percentage of predicted errors achieved revealed the convolution technique as a proficient procedure for predicting plasma drug levels of ibuprofen LS.