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Evaluation of In-Die Compression Data for a Deeper Understanding of Altered Excipient Properties upon Temperature

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Summary

Tablet compression analysis reveals temperature impacts on excipient properties. Elevated temperatures reduce work for plastic deformation in ductile polymers, indicating material changes detectable from compression data.

Keywords:
deformation behaviorenergy parametersforce–displacementheated tabletingplasticity factor

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Area of Science:

  • Pharmaceutical sciences
  • Materials science
  • Chemical engineering

Background:

  • Tablet formation involves complex thermodynamic and mechanical processes during compression.
  • Understanding how temperature influences excipient properties is crucial for optimizing tablet manufacturing.
  • Excipient behavior can change significantly with temperature, affecting tablet quality.

Purpose of the Study:

  • To evaluate changes in force-displacement data as an indicator of altered excipient properties due to temperature increases.
  • To investigate the thermodynamic and mechanical analysis of tablet formation under varying temperatures.
  • To correlate compression data with material properties like glass transition temperature.

Main Methods:

  • Utilized a thermally controlled die on a tablet press to simulate industrial heat evolution.
  • Compressed six ductile polymers and lactose (brittle reference) at temperatures from 22-70°C.
  • Performed energy analysis (net work, recovery work, plasticity factor) and Heckel analysis.

Main Results:

  • Elevated temperatures decreased net work of compaction and plasticity factor for ductile polymers, indicating reduced work for plastic deformation.
  • Recovery work slightly increased at maximum tableting temperatures.
  • Lactose showed no significant response to temperature variations.
  • Changes in net work of compaction linearly correlated with yield pressure changes, linked to glass transition temperature.

Conclusions:

  • Temperature variations can alter the mechanical properties of ductile polymer excipients during tableting.
  • Force-displacement data, particularly net work of compaction, can detect material alterations if the glass transition temperature is sufficiently low.
  • This thermodynamic analysis provides a method for in-process monitoring of material changes during tablet manufacturing.