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Challenges in Rheological Characterization of Highly Concentrated Suspensions — A Case Study for Screen-printing Silver Pastes
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In-process rheometry as a PAT tool for hot melt extrusion.

A L Kelly1, T Gough1, M Isreb1

  • 1a Centre for Pharmaceutical Engineering Science , University of Bradford , Bradford , UK.

Drug Development and Industrial Pharmacy
|November 23, 2017
PubMed
Summary
This summary is machine-generated.

Real-time melt rheology monitoring using a slit die offers a simple tool for Process Analytical Technology (PAT) in hot melt extrusion. This method effectively tracks active pharmaceutical ingredient (API) loading and process parameters for enhanced understanding.

Keywords:
Polymerdrugin-lineprocess analytical technologyrheologysolid dispersiontwin screw extrusion

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Area of Science:

  • Pharmaceutical Technology
  • Polymer Science
  • Process Engineering

Background:

  • Hot melt extrusion (HME) is a key process for pharmaceutical manufacturing.
  • Monitoring HME in real-time is crucial for process control and product quality.
  • Process Analytical Technology (PAT) aims to improve process understanding and control.

Purpose of the Study:

  • To investigate real-time melt rheology measurement as a PAT tool for HME.
  • To monitor the influence of active pharmaceutical ingredient (API) loading and temperature on melt properties.
  • To assess the sensitivity of rheological parameters to changes in API concentration.

Main Methods:

  • Utilized a twin-screw extruder equipped with an instrumented rheological slit die.
  • Integrated pressure transducers to measure pressure drop across the die.
  • Calculated rheological parameters like shear viscosity and exit pressure at various extrusion throughputs.
  • Melted a developmental API with a commercial copolymer at different API loadings and temperatures.

Main Results:

  • Observed shear-thinning behavior in the polymer-API melt.
  • Melt viscosity decreased with increasing API loading and extrusion temperature.
  • Exit pressure and shear viscosity were sensitive indicators of API loading.
  • Demonstrated the potential for in-line material attribute measurement.

Conclusions:

  • Real-time melt rheology measurement is a viable PAT tool for HME.
  • The technique provides valuable insights into API loading and process variations.
  • This method can enhance overall process understanding and control in pharmaceutical extrusion.