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Hot-Melt Extrusion: a Roadmap for Product Development.

Marta F Simões1,2, Rui M A Pinto1, Sérgio Simões3,4

  • 1Bluepharma - Indústria Farmacêutica, São Martinho do Bispo, 3045-016, Coimbra, Portugal.

AAPS Pharmscitech
|June 18, 2021
PubMed
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Hot-melt extrusion (HME) is a key pharmaceutical technology for improving drug solubility and bioavailability through amorphous solid dispersions. This review covers HME principles, applications, and quality considerations for drug formulation.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Hot-melt extrusion (HME) is increasingly utilized in pharmaceutical manufacturing.
  • Key applications include enhancing drug solubility, taste masking, and controlling drug release profiles.
  • Amorphous solid dispersions are a primary focus for bioavailability enhancement using HME.

Purpose of the Study:

  • To review the significant aspects of HME technology for preparing amorphous solid dispersions.
  • To discuss molecular and thermodynamic factors influencing the properties of these drug systems.
  • To highlight the importance of Quality by Design and process analytical technologies in HME.

Main Methods:

  • Review of current literature on hot-melt extrusion in pharmaceutical formulations.
Keywords:
amorphous solid dispersionshot-melt extrusionpolymersquality by designsolubility enhancement

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  • Analysis of molecular interactions and thermodynamic principles in amorphous solid dispersions.
  • Discussion of Quality by Design and process analytical technologies in HME.

    • Main Results:

    • HME is a versatile technique for creating amorphous solid dispersions to improve solubility of poorly soluble drugs.
    • Miscibility and physical stability are critical physicochemical properties influenced by molecular and thermodynamic factors.
    • Integration of Quality by Design and process analytical technologies ensures robust pharmaceutical product development.

    Conclusions:

    • Hot-melt extrusion offers a viable strategy for enhancing drug solubility and bioavailability.
    • Understanding the physicochemical properties is crucial for successful formulation development.
    • Adherence to Quality by Design and advanced monitoring technologies is essential for regulatory compliance and product quality.