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Optimization of radial extrusion and pellet coating processes using PAT approaches
A Gradišek1, G Ratek1, F Vrečer2
1Krka d. d., Novo mesto, Slovenia.
Summary
Process Analytical Technology (PAT) was applied to optimize pharmaceutical pellet production and film coating. At-line Near-Infrared (NIR) probes accurately predicted coating quantity, demonstrating PAT
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Analytical Chemistry
Background:
- The FDA's initiative 'Pharmaceutical CGMPs for the 21st Century' promotes risk-based approaches in drug manufacturing.
- Process Analytical Technology (PAT) enables enhanced understanding and control of complex pharmaceutical processes.
- Radial extrusion and pellet coating are critical processes with numerous parameters suitable for PAT implementation.
Purpose of the Study:
- To optimize neutral pellet production for desired film coating properties using Design of Experiments (DoE).
- To predict film coating quantity in real-time using in-line and at-line Near-Infrared (NIR) probes.
- To compare the performance of in-line and at-line NIR probes for coating quantity prediction.
Main Methods:
- Design of Experiments (DoE) was employed to optimize neutral pellet production parameters.
- In-line and at-line Near-Infrared (NIR) probes were utilized for real-time monitoring during film coating.
- UV/VIS spectroscopy was used as a reference method for coating quantity determination.
Main Results:
- Optimized pellet production achieved desired properties: narrow particle size distribution, high sphericity, and high process yield.
- Both in-line and at-line NIR probes allowed successful calibration for predicting coating quantity.
- At-line NIR demonstrated excellent prediction performance, enabling accurate process endpoint determination with <2.0% deviation from target.
- In-line NIR showed slightly lower model quality and overprediction due to inferior spectral resolution.
Conclusions:
- PAT tools, particularly at-line NIR, can effectively optimize pellet production and predict film coating quantity in pharmaceutical manufacturing.
- At-line NIR offers a reliable method for real-time process monitoring and control in film coating operations.
- Further investigation into in-line NIR probe technology may be needed to improve spectral resolution and prediction accuracy.
