OSD

Accelerating tablet tech-transfer through predictive modelling: Overcoming tablet quality challenges

Tech-transfer of oral solid dosage forms often faces setbacks due to shifts in material behavior and process variability. In this case study, Recipharm showcases how its ReciPredict platform with it's predictive, model-driver approach, enabled a failing tablet manufacturing process to be transformed into a validated success in just five months.

Key highlights:

  • Challenge: Poor flowability and inconsistent granule quality led to failed validations and unresolved variability in tablet hardness and dissolution.
  • Conventional troubleshooting fell short due to isolated parameter testing through trial and error.
  • Solution: ReciPredict applied a model-driven approach to simulate success, predict critical quality attributes (CQAs), and identify optimal process conditions.
  • Results:
    • Tablet hardness deviation: < 2 N
    • Dissolution deviation: < 1.5%
    • Validation achieved in just 5 months
    • Reduced material use and cost
    • Generated regulatory-ready data

 

Why it matters:

This approach demonstrates how data-driven development can accelerate timelines, reduce risk, and improve scalability, delivering robust outcomes with fewer trials and greater confidence.

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