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A Hot-Melt Extrusion Risk Assessment Classification System for Amorphous Solid Dispersion Formulation Development.

Samuel O Kyeremateng1, Kristin Voges1, Stefanie Dohrn1

  • 1AbbVie Deutschland GmbH & Co. KG, Global Pharmaceutical R&D, Knollstraße, D-67061 Ludwigshafen am Rhein, Germany.

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|May 28, 2022
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Summary
This summary is machine-generated.

A new hot-melt extrusion (HME) risk classification system (HCS) uses active pharmaceutical ingredient (API)-polymer phase diagrams to assess risks for amorphous solid dispersion (ASD) formulations. This material-sparing tool aids in developing high-melting-temperature APIs for HME processing.

Keywords:
APC™HME process design spaceHME risk classification systemamorphous solid dispersioncopovidonehot-melt extrusionquality-by-designsoluplussulfamerazinetelmisartan

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • API-polymer phase diagrams are proposed for identifying processing temperatures in amorphous solid dispersion (ASD) formulations via hot-melt extrusion (HME).
  • Systematic investigations and reliable applications of phase diagrams as risk assessment tools for HME are lacking.
  • High melting temperature APIs are often considered unsuitable for HME due to processing challenges.

Purpose of the Study:

  • To develop and validate a material-sparing risk classification system (HCS) based on API-polymer phase diagrams for early risk assessment in HME.
  • To provide a framework for API risk categorization in the development of ASDs using HME.
  • To explore the utility of API-polymer phase diagrams for process design space selection, considering thermal degradation and dissolution kinetics.

Main Methods:

  • Development of an HME risk classification system (HCS) utilizing API-polymer phase diagrams.
  • Application of the HCS for risk assessment of high melting temperature APIs.
  • Experimental validation using HME with sulfamerazine and telmisartan and polymers Copovidone and Soluplus.
  • Analysis of amorphous solid dispersions for residual crystallinity and degradation.

Main Results:

  • The HCS effectively categorizes API risks for HME processing of ASDs.
  • HME experiments demonstrated excellent agreement between preassigned HCS classes and the resulting ASD properties (crystallinity, degradation).
  • The developed system proved robust and validated over 8 years, applied to over 60 APIs.

Conclusions:

  • API-polymer phase diagrams can be reliably used as a risk assessment tool for HME process development.
  • The HCS is a valuable quality-by-design (QbD) tool for developing amorphous solid dispersions via hot-melt extrusion, especially for challenging APIs.
  • The HCS facilitates efficient and early risk assessment, enabling the successful development of HME ASDs.