AAPS PharmSciTech

, Volume 15, Issue 6, pp 1447–1453 | Cite as

Integrating Artificial and Human Intelligence into Tablet Production Process

  • Matjaž Gams
  • Matej Horvat
  • Matej Ožek
  • Mitja Luštrek
  • Anton GradišekEmail author
Research Article


We developed a new machine learning-based method in order to facilitate the manufacturing processes of pharmaceutical products, such as tablets, in accordance with the Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives. Our approach combines the data, available from prior production runs, with machine learning algorithms that are assisted by a human operator with expert knowledge of the production process. The process parameters encompass those that relate to the attributes of the precursor raw materials and those that relate to the manufacturing process itself. During manufacturing, our method allows production operator to inspect the impacts of various settings of process parameters within their proven acceptable range with the purpose of choosing the most promising values in advance of the actual batch manufacture. The interaction between the human operator and the artificial intelligence system provides improved performance and quality. We successfully implemented the method on data provided by a pharmaceutical company for a particular product, a tablet, under development. We tested the accuracy of the method in comparison with some other machine learning approaches. The method is especially suitable for analyzing manufacturing processes characterized by a limited amount of data.


artificial intelligence machine learning process analytical technology process optimization tablet manufacture 



Artificial intelligence


Machine learning


Process Analytical Technology


Quality by Design



The authors thank the Slovenian Research Agency (ARRS) for the financial support.


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Copyright information

© American Association of Pharmaceutical Scientists 2014

Authors and Affiliations

  • Matjaž Gams
    • 1
  • Matej Horvat
    • 2
  • Matej Ožek
    • 1
  • Mitja Luštrek
    • 1
  • Anton Gradišek
    • 1
    Email author
  1. 1.Department of Intelligent SystemsJožef Stefan InstituteLjubljanaSlovenia
  2. 2.Sandoz Biopharmaceuticals MengešMengešSlovenia

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