RESUMO
Tablet defects encountered during the manufacturing of oral formulations can result in quality concerns, timeline delays, and elevated financial costs. Internal tablet cracking is not typically measured in routine inspections but can lead to batch failures such as tablet fracturing. X-ray computed tomography (XRCT) has become well-established to analyze internal cracks of oral tablets. However, XRCT normally generates very large quantities of image data (thousands of 2D slices per data set) which require a trained professional to analyze. A user-guided manual analysis is laborious, time-consuming, and subjective, which may result in a poor statistical representation and inconsistent results. In this study, we have developed an analysis program that incorporates deep learning convolutional neural networks to fully automate the XRCT image analysis of oral tablets for internal crack detection. The computer program achieves robust quantification of internal tablet cracks with an average accuracy of 94%. In addition, the deep learning tool is fully automated and achieves a throughput capable of analyzing hundreds of tablets. We have also explored the adaptability of the deep learning analysis program toward different products (e.g., different types of bottles and tablets). Finally, the deep learning tool is effectively implemented into the industrial pharmaceutical workflow.