Application of Deep Learning Convolutional Neural Networks for Internal Tablet Defect Detection: High Accuracy, Throughput, and Adaptability.

Journal: Journal of pharmaceutical sciences
Published Date:

Abstract

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.

Authors

  • Xiangyu Ma
    Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Austin, Texas 78712.
  • Nada Kittikunakorn
    Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Austin, Texas 78712.
  • Bradley Sorman
    ExecuPharm, 610 Freedom Business Center Drive, Suite 200, King of Prussia, Pennsylvania 19406.
  • Hanmi Xi
    MRL, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania 19486.
  • Antong Chen
    MRL, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania 19486.
  • Mike Marsh
    Object Research Systems, 760 St-Paul West, Suite 101, Montreal, Quebec H3C 1M4, Canada.
  • Arthur Mongeau
    Object Research Systems, 760 St-Paul West, Suite 101, Montreal, Quebec H3C 1M4, Canada.
  • Nicolas Piché
    Object Research Systems, 760 St-Paul West, Suite 101, Montreal, Quebec H3C 1M4, Canada.
  • Robert O Williams
    Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, 2409 University Avenue, Austin, Texas 78712.
  • Daniel Skomski
    MRL, Merck & Co., Inc., 126 E. Lincoln Avenue, Rahway, New Jersey 07065. Electronic address: daniel.skomski@merck.com.