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Downstream processing from hot-melt extrusion towards tablets: A quality by design approach.
W Grymonpré1, N Bostijn2, S Van Herck1
1Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
International Journal of Pharmaceutics
|August 22, 2017
Summary
Hot-melt extrusion (HME) is a robust process for pharmaceutical manufacturing. Adjusting formulation parameters, like drug load, optimizes extrudate and tablet quality, while process parameters have minimal impact.
Area of Science:
- Pharmaceutical Manufacturing
- Materials Science
Background:
- Continuous processing is increasingly important in pharmaceutical manufacturing.
- Understanding process and formulation impacts on critical quality attributes (CQA) is crucial.
Purpose of the Study:
- To investigate the influence of process parameters and drug load during hot-melt extrusion (HME) on extrudate and tableting properties.
- To apply a quality-by-design (QbD) approach to amorphous solid dispersion formulations.
Main Methods:
- A full factorial design with 19 experiments evaluated barrel temperature, screw speed, throughput, and drug load.
- Soluplus®-Celecoxib amorphous solid dispersions were used.
- Raman spectroscopy and PLS modeling were employed for API quantification.
Main Results:
- Formulation parameters significantly impacted extrudate and tablet CQAs.
- The polymer matrix demonstrated resistance to thermo-mechanical stress during HME.
- Raman spectroscopy enabled accurate API quantification within 3% deviation.
Conclusions:
- HME is a robust process for creating amorphous glassy solutions suitable for tableting.
- Process parameters had minimal impact on extrudate and tablet properties.
- Formulation parameters, particularly drug load, are key for optimizing extrudate and tablet quality.
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