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Power consumption measurement and temperature recording during granulation
Gabriele Betz1, Pascale Junker Bürgin, Hans Leuenberger
1Department of Pharmacy, Institute of Pharmaceutical Technology, University of Basel, Klingelbergstr. 50, 4056 Basel, Switzerland.
International Journal of Pharmaceutics
|March 17, 2004
Summary
This study introduces a new "TPR factor" using temperature and power consumption to characterize granulation formulation design. This method offers insights for robust drug dosage form development and Process Analytical Technology (PAT).
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Materials Science
Background:
- Understanding granulation is crucial for robust dosage form design.
- Current methods for granulation endpoint detection can be improved.
- Process Analytical Technology (PAT) is a key initiative for pharmaceutical quality.
Purpose of the Study:
- To elucidate the influences of process and formulation design on granulation.
- To introduce novel in-process measurements for granulation control.
- To establish a new metric for characterizing formulation design during granulation.
Main Methods:
- Utilized in-process power consumption measurements with a computer program for endpoint detection.
- Recorded temperature increase (DeltaT) in the wet powder bed using a temperature sensor.
- Introduced the Temperature-to-Power Ratio (TPR) factor as a signature of formulation design.
Main Results:
- Temperature increase maxima occurred at 130% saturation, while power consumption maxima occurred at 100% saturation.
- The TPR factor was dependent on particle size, surface properties, water absorption, and solubility.
- The TPR factor proved independent of process design parameters like mixer filling level.
Conclusions:
- The TPR factor serves as a formulation design signature during granulation.
- In-process monitoring using TPR factor aligns with 21st-century drug quality systems and PAT.
- Future work will involve developing an artificial neural network for in-process granulation control based on these findings.