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Advancing Direct Tablet Compression with AI: A multi-task framework for quality control, batch acceptance, and causal

Yazid Bounab1, Osmo Antikainen1, Mia Sivén1

  • 1University of Helsinki, Faculty of Pharmacy, Viikinkaari 5 E, Helsinki, 00014, Finland.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|June 13, 2025
PubMed
Summary
This summary is machine-generated.

This study introduces an AI framework for pharmaceutical manufacturing, enhancing direct tablet compression (DTC) by predicting tablet quality and identifying issues. The system improves efficiency and ensures regulatory compliance in drug development.

Keywords:
Direct Tablet CompressionGenerative artificial intelligenceNeural networksTablet quality controlTabular Data Augmentation

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Area of Science:

  • Pharmaceutical Manufacturing
  • Drug Development
  • Artificial Intelligence in Pharma

Background:

  • Pharma 4.0 is transforming drug development with AI for enhanced efficiency.
  • Direct Tablet Compression (DTC) relies heavily on API and excipient properties.
  • Optimizing tablet quality requires understanding complex interactions.

Purpose of the Study:

  • To develop a novel multi-task AI framework for predicting tablet properties.
  • To determine batch acceptance and provide insights for quality improvement.
  • To enable real-time monitoring and regulatory compliance in pharmaceutical manufacturing.

Main Methods:

  • A multi-task framework combining regression, classification, and text generation.
  • Integration of statistical methods, Neural Networks (NN), Natural Language Processing (NLP), and Generative AI (GenAI).
  • Validation using the Harvard Dataverse V1 dataset of Fast Disintegrating Tablets (FDTs).

Main Results:

  • Achieved 91.8% R² for regression and 95.5% accuracy for classification.
  • Demonstrated superior performance over state-of-the-art methods.
  • Successfully predicted tablet properties (friability, hardness, disintegration, water absorption).

Conclusions:

  • The AI framework significantly enhances pharmaceutical manufacturing quality control.
  • It provides actionable insights for optimizing tablet production and identifying root causes of defects.
  • The approach supports real-time monitoring, compliance, and improved drug development outcomes.