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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Pharmaceutical hot melt extrusion process development using QbD and digital twins.

Josip Matić1, Milica Stanković-Brandl1, Hannes Bauer1

  • 1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.

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Summary

Investigating screw geometry in pharmaceutical hot melt extrusion (HME) is crucial for Quality by Design (QbD). This study reveals triple-flighted screws enhance conveying and pressure build-up compared to double-flighted designs.

Keywords:
1D HMEMechanistic modelingModel validationNANO16Pharmaceutical hot melt extrusionScale-upSmoothed particle hydrodynamicsZSE18

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Area of Science:

  • Pharmaceutical Engineering
  • Process Chemistry
  • Materials Science

Background:

  • Quality by Design (QbD) in pharmaceutical development relies on understanding critical process parameters (CPPs) for desired critical quality attributes (CQAs).
  • Hot melt extrusion (HME) process setup is influenced by parameters like screw speed, throughput, temperature, and configuration.
  • The impact of screw element cross-section geometry, a less-researched CPP, on HME performance is investigated.

Purpose of the Study:

  • To evaluate the effect of different screw element cross-section geometries (triple-flighted vs. double-flighted) in pharmaceutical HME.
  • To compare the performance of a triple-flighted extruder (NANO16) with a double-flighted extruder (ZSE18) using experimental and in silico methods.
  • To assess the processability and scalability of formulations across different screw geometries.

Main Methods:

  • Utilized experimental processing of two formulations on a NANO16 (triple-flighted) extruder.
  • Employed in silico methods, including detailed smoothed particle hydrodynamics (SPH) simulations and reduced-order 1D HME simulations.
  • Validated 1D HME simulations against experimental data for process space and scalability analysis.
  • Investigated conveying efficiency, pressure build-up, and power consumption of screw elements from both extruders.

Main Results:

  • Detailed SPH simulations elucidated the conveying, pressure build-up, and power consumption characteristics of various screw elements.
  • Reduced-order 1D HME simulations demonstrated the process space and scalability for both extruder types.
  • Experimental validation confirmed the findings from the 1D HME simulations.
  • The study provides insights into the performance differences between triple-flighted and double-flighted screw geometries in HME.

Conclusions:

  • Screw element cross-section geometry is a significant CPP in pharmaceutical HME, impacting process performance.
  • Triple-flighted screw elements demonstrate distinct conveying and pressure-building capabilities compared to double-flighted elements.
  • The integration of SPH and 1D HME simulations, validated experimentally, offers a robust approach for process understanding and scale-up in HME.