Evaluation of the transferability of an image analysis approach of X-ray micro-computed tomography images for the application with a new validation concept for in silico tools

Abstract

It is possible to validate in silico tools for predicting quality attributes such as dissolution by using processed X-ray micro-computed tomography (XμCT) images of real pharmaceutical formulations as virtual matrices. Different batches of oral films were produced and imaged with XμCT. Over 30 million virtual matrices were evaluated and assessed. The highest performing image processing pathways were used for visual verification. The goal of this work was to assess the transferability of the concept of XμCT image based virtual matrices from tablets to oral films and to evaluate issues and limitations of the transferred concept to test feasibility. In principle, the images were suitable for usage in the validation concept but air bubbles in the oral films caused artefacts in the XμCT images which were identified by confocal Raman microscopy. The final processed images represented the raw images including the artefacts. Therefore, the virtual matrices based on films with air bubbles did not represent the real oral films and could not be used for the in silico calculations. The images of oral films without air bubbles were appropriate.