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Polymorphic Transformation of Indomethacin during Hot Melt Extrusion Granulation: Process and Dissolution Control.

Ting Xu1, Kajalajit Nahar1, Rutesh Dave1

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Processing stresses during hot melt extrusion influence indomethacin solid-state changes. Controlling temperature and cooling rates allows for targeted isolation of specific indomethacin polymorphs in granules.

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Materials Science

Background:

  • Indomethacin (IMC) exists in multiple polymorphic forms, impacting drug product performance.
  • Hot melt extrusion (HME) is a viable granulation technique for amorphous solid dispersions.
  • Controlling solid-state transformations during HME is crucial for consistent drug product quality.

Purpose of the Study:

  • To investigate the impact of processing stresses (temperature, duration, shear) on indomethacin solid-state transformations during HME.
  • To elucidate the mechanisms of polymorphic transitions of indomethacin (IMC) and polyethylene glycol 3350 (PEG 3350) blends during HME.
  • To develop a design space for controlling indomethacin polymorphs in HME granules.

Main Methods:

  • Granulation of α-indomethacin and PEG 3350 blends using HME with varied screw designs and temperatures.
  • Characterization of solid-state forms using Differential Scanning Calorimetry (DSC) and X-ray Powder Diffraction (XRPD).
  • Development of an XRPD-based quantitative method for analyzing amorphous, α-IMC, γ-IMC, and PEG in process samples and granules.

Main Results:

  • Elevated temperatures (≥130°C) and shear stress accelerated the conversion of amorphous and α-IMC to γ-IMC during the heating phase.
  • Rapid cooling post-extrusion favored the formation and isolation of the meta-stable α-IMC polymorph.
  • Quantitative XRPD analysis provided insights into the spatial distribution of polymorphs within the HME process zones and final granules.

Conclusions:

  • A process design space was established to control indomethacin polymorphic forms in HME granules.
  • Understanding the interplay between thermodynamic stability and transformation kinetics is key to controlling polymorph outcomes.
  • This study provides a framework for optimizing HME processes to achieve desired solid-state properties in pharmaceutical formulations.