title: Integrating artificial and human intelligence into tablet production process.
abstract: 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.
authors: Department of Intelligent Systems, Jožef Stefan Institute, Jamova 39, SI-1000, Ljubljana, Slovenia.
authors: Matjaž
authors: M
authors: Gams
authors: Matej
authors: M
authors: Horvat
authors: Matej
authors: M
authors: Ožek
authors: Mitja
authors: M
authors: Luštrek
authors: Anton
authors: A
authors: Gradišek
mesh_terms: D000465:Algorithms; D001185:Artificial Intelligence; D002626:Chemistry, Pharmaceutical; D003663:Decision Trees; D005079:Excipients / Q000737:chemistry* / Q000592:standards; D006801:Humans; D007360:Intelligence; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D018511:Systems Integration; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D014584:User-Computer Interface
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets