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Analysis and Specification of Starch Granule Size Distributions
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Process Analytical Technology for High Shear Wet Granulation: Wet Mass Consistency Reported by In-Line Drag Flow

Ajit S Narang1, Valery Sheverev2, Tim Freeman3

  • 1Bristol-Myers Squibb, Co., New Brunswick, New Jersey 08903.

Journal of Pharmaceutical Sciences
|February 9, 2016
PubMed
Summary
This summary is machine-generated.

The drag flow force (DFF) sensor effectively monitors wet mass consistency during high shear wet granulation. Its measurements correlate with material properties, aiding process development and manufacturing control.

Keywords:
DFF sensorFT4 Powder Rheometer(®)formulationgranulationhigh shear wet granulationhigh throughput technologiespowder technologyprocess analytical technologiesprocessingunit operations

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Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Process Analytical Technology

Background:

  • High shear wet granulation is crucial for pharmaceutical manufacturing.
  • Process Analytical Technology (PAT) enables real-time monitoring.
  • Drag Flow Force (DFF) sensors offer potential for in-line monitoring of wet mass.

Purpose of the Study:

  • To evaluate the Drag Flow Force (DFF) sensor's capability in monitoring wet mass consistency during high shear wet granulation.
  • To correlate DFF sensor measurements with established powder rheology techniques.
  • To assess the DFF sensor's utility in predicting granulation endpoint and material properties.

Main Methods:

  • Utilized a DFF sensor for real-time, in-line measurement of force exerted by wet mass.
  • Conducted high shear wet granulation experiments with three placebo formulations varying in binder content.
  • Collected wet granules at different time points for concurrent characterization using an FT4 Powder Rheometer.

Main Results:

  • DFF sensor measurements showed strong correlation with wet granule resistance to flow and interparticulate interactions, as assessed by the FT4 Powder Rheometer.
  • The force pulse magnitude measured by the DFF sensor indicated changes in fundamental material properties like shear viscosity and granule size/density.
  • DFF sensor data aligned with independently established granulation endpoints.

Conclusions:

  • The DFF sensor is a valuable tool for real-time monitoring of wet mass consistency in high shear wet granulation.
  • DFF sensor measurements provide insights into critical material attributes and process dynamics.
  • The DFF sensor supports formulation development, process optimization, scale-up, and manufacturing control.