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A New Validation Methodology for In Silico Tools Based on X-ray Computed Tomography Images of Tablets and a Performance Analysis of One Tool

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The validation of in silico tools predicting the dissolution of pharmaceutical dosage forms through virtual matrices can be accomplished using X-ray micro-computed tomography images of actual pharmaceutical formulations. In this study, processed images from three distinct tablet batches were utilized to assess the performance of the in silico tool F-CAD. The primary objective was to demonstrate the software's efficacy by comparing predicted dissolution profiles with experimental ones and to evaluate the viability and application of the validation concept for in silico tools. Virtual matrices, derived from X-ray micro-computed tomography images, as well as those designed by the software itself, were employed. The resulting dissolution curves were scrutinized for their similarity to the experimental curve, and the kinetics were analyzed using the Higuchi and Korsmeyers–Peppas plot. The entire validation concept proved to be feasible and effective. It successfully identified prediction errors in the F-CAD software and highlighted issues with the virtual tablets designed within the software.
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