Machine Learning for Process Monitoring and Control of Hot-Melt Extrusion: Current State of the Art and Future Directions.

Pharmaceutics

Centre for Mathematical Modelling and Intelligent Systems for Health and Environment (MISHE), Institute of Technology Sligo, Ash Lane, F91 YW50 Sligo, Co. Sligo, Ireland.

Published: September 2021

AI Article Synopsis

  • Hot-melt extrusion (HME) has gained popularity in the pharmaceutical industry for its advantages in drug delivery system fabrication.
  • The FDA's 'quality by design' approach has spurred research on using process analytical technology (PAT) like NIR, Raman, and UV-Vis in conjunction with machine learning for real-time monitoring of HME.
  • This review evaluates the role of machine learning in pharmaceutical HME processes, addressing current challenges and outlining future directions for improvement in the field.

Article Abstract

In the last few decades, hot-melt extrusion (HME) has emerged as a rapidly growing technology in the pharmaceutical industry, due to its various advantages over other fabrication routes for drug delivery systems. After the introduction of the 'quality by design' (QbD) approach by the Food and Drug Administration (FDA), many research studies have focused on implementing process analytical technology (PAT), including near-infrared (NIR), Raman, and UV-Vis, coupled with various machine learning algorithms, to monitor and control the HME process in real time. This review gives a comprehensive overview of the application of machine learning algorithms for HME processes, with a focus on pharmaceutical HME applications. The main current challenges in the application of machine learning algorithms for pharmaceutical processes are discussed, with potential future directions for the industry.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8466632PMC
http://dx.doi.org/10.3390/pharmaceutics13091432DOI Listing

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