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Process analytical techniques for hot-melt extrusion and their application to amorphous solid dispersions.

Patrick Hitzer1, Tim Bäuerle1, Tobias Drieschner1

  • 1Process Analysis and Technology (PA&T), Faculty Applied Chemistry, Reutlingen University, Alteburgstr. 150, 72762, Reutlingen, Germany.

Analytical and Bioanalytical Chemistry
|March 27, 2017
PubMed
Summary

Newly developed poorly soluble active pharmaceutical ingredients (APIs) can be formulated into amorphous solid dispersions (ASDs) using hot-melt extrusion (HME). This review evaluates spectroscopic methods for quantifying crystalline API content in ASDs for process control.

Keywords:
Amorphous solid dispersionsHot-melt extrusionPharmaceutical manufacturingProcess analytical technologyUV/VIS spectroscopyVibrational spectroscopy

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Materials Science

Background:

  • Poor water solubility of new active pharmaceutical ingredients (APIs) limits bioavailability.
  • Amorphous solid dispersions (ASDs) formulated via hot-melt extrusion (HME) enhance API solubility.
  • Controlling API crystallinity in ASDs is crucial for drug product performance.

Purpose of the Study:

  • To review and assess analytical methods for characterizing ASDs.
  • To evaluate techniques for quantifying crystalline API content in ASDs.
  • To discuss the suitability of methods as process analytical technology (PAT) tools for HME.

Main Methods:

  • Review of spectroscopic techniques including near-infrared (NIR), mid-infrared (MIR), Raman, UV/VIS, terahertz, and ultrasonic spectroscopy.
  • Analysis of methods for in-line and on-line process analytics during HME.
  • Discussion of advantages and limitations of each technique for industrial manufacturing.

Main Results:

  • Spectroscopic methods are effective for characterizing ASDs and quantifying crystalline API content.
  • NIR, MIR, and Raman spectroscopy are well-established techniques.
  • Emerging techniques like terahertz and ultrasonic spectroscopy show potential for ASD analysis.
  • Suitability for PAT integration in HME varies among methods.

Conclusions:

  • Spectroscopic techniques are vital for the quality control of amorphous solid dispersions (ASDs).
  • The selection of analytical methods depends on specific requirements for in-line, on-line, or at-line process monitoring.
  • Further development is needed to fully integrate advanced spectroscopic tools into hot-melt extrusion processes.