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Managing active pharmaceutical ingredient raw material variability during twin-screw blend feeding.

F Stauffer1, V Vanhoorne2, G Pilcer3

  • 1Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Ghent, Belgium.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|December 25, 2018
PubMed
Summary

Continuous powder feeding challenges with poorly flowing active pharmaceutical ingredients (APIs) were overcome by reformulation. Transferring glidants improved blend flowability and mitigated API variability impacts on twin-screw feeding.

Keywords:
Continuous manufacturingManaging active pharmaceutical ingredient variabilityMaterial propertiesMultivariate data analysisQuality by designTwin-screw feeding

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Materials Science

Background:

  • Continuous powder feeding is essential for consistent solid dosage form manufacturing.
  • Poorly flowing active pharmaceutical ingredients (APIs) and their batch variability pose significant challenges to twin-screw feeding capacity and process consistency.

Purpose of the Study:

  • To investigate and improve twin-screw feeding of pharmaceutical blends containing a poorly flowing API with high batch-to-batch variability.
  • To evaluate formulation modifications aimed at enhancing blend flowability and mitigating API variability effects on feeding performance.

Main Methods:

  • Extensive material characterization of reformulated blends.
  • Continuous twin-screw feeding evaluation tests.
  • Assessment of formulation changes on blend properties and feeding behavior.

Main Results:

  • Transferring the glidant to the intra-granular phase significantly improved blend flowability.
  • Sufficient feeding capacity was achieved, and the impact of API batch variability on twin-screw feeding was mitigated.
  • Key material attributes critical for feeding were identified: bulk density, mass charge, and powder cohesiveness.

Conclusions:

  • Reformulation strategies, specifically glidant transfer, can successfully address challenges in continuous powder feeding of difficult-to-handle APIs.
  • Optimized formulations ensure consistent feeding performance and mitigate raw material variability, crucial for robust continuous manufacturing.
  • Understanding critical material attributes is key to successful process development in pharmaceutical powder handling.