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Batch versus continuous blending of binary and ternary pharmaceutical powder mixtures
Maarten Jaspers1, Sri Sharath Kulkarni1, Florian Tegel2
1DFE Pharma, Klever Strasse 187, 47568 Goch, Germany.
International Journal of Pharmaceutics: X
|January 14, 2022
Summary
Continuous manufacturing offers robust blend uniformity for pharmaceutical powders, unlike traditional batch processes. Material properties significantly impact blending in batch methods but are less critical in continuous blending, ensuring consistent homogeneity.
Area of Science:
- Pharmaceutical Manufacturing
- Materials Science
- Chemical Engineering
Background:
- Material properties of excipients and active pharmaceutical ingredients (APIs) are critical for blend uniformity in pharmaceutical powder formulations.
- The pharmaceutical industry is transitioning from batch to continuous manufacturing, necessitating an understanding of blending in these new processes.
Purpose of the Study:
- To investigate the impact of material properties on blending performance in both batch and continuous pharmaceutical manufacturing processes.
- To compare the blend homogeneity achieved through traditional batch blending versus continuous blending.
Main Methods:
- Studied the blending of active pharmaceutical ingredients (APIs) and excipients in both batch and continuous processing setups.
- Analyzed the homogeneity of the resulting powder mixtures using appropriate analytical techniques.
Main Results:
- The influence of material properties on blending performance differs significantly between batch and continuous processes.
- Continuous blending demonstrated greater robustness, yielding uniform blends across a wide range of blend compositions.
- Parameters like particle size, density, and flowability, which are critical in batch blending, have a reduced impact in continuous systems.
Conclusions:
- Continuous manufacturing processes are more forgiving regarding material property variations for achieving blend uniformity.
- The shift to continuous manufacturing simplifies the control of blend homogeneity, as it is less dependent on specific material characteristics.
Keywords:
Active pharmaceutical ingredientsBlend uniformityContinuous blendingContinuous manufacturingExcipientsPowder blendingMore Related Videos
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