International Journal on Science and Technology

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The Hot Melt Extrusion (HME) in Pharmaceutical Technology: A Comprehensive Review

Author(s) Prashant Halagali, Bhuvaneshwari R. Sharannavar
Country India
Abstract Hot Melt Extrusion (HME) is an innovative and versatile technology that has significantly impacted pharmaceutical formulation and drug delivery. Originally developed for the plastics industry, HME has been successfully adapted for pharmaceutical use due to its solvent-free and continuous processing capabilities. It is particularly beneficial for enhancing the solubility and bioavailability of poorly water-soluble drugs. The process involves the application of heat and shear force to produce homogeneous extrudates, enabling the development of solid dispersions, controlled-release formulations, and complex drug delivery systems. Twin-screw extruders are commonly preferred over single-screw systems due to their superior mixing efficiency and scalability. HME offers several advantages, including improved drug stability, enhanced patient compliance, and environmental friendliness. However, challenges such as thermal degradation of heat-sensitive drugs and the need for specialized equipment remain. Critical process parameters—including temperature, screw speed, and feed rate—must be carefully optimized. A wide range of materials, such as pharmaceutical-grade polymers and plasticizers, are employed, with appropriate selection being essential for desired drug release and stability. Characterization techniques like DSC, TGA, XRD, and FTIR help evaluate drug-polymer interactions and extrudate properties. Emerging innovations, such as 3D printing integration and real-time process monitoring, are expanding the potential of HME, particularly in personalized medicine and continuous manufacturing.
Keywords Hot Melt Extrusion, Solid Dispersions, Drug Delivery Systems, Twin-screw extruder, Bioavailability Enhancement.
Field Medical / Pharmacy
Published In Volume 16, Issue 2, April-June 2025
Published On 2025-05-14
DOI https://doi.org/10.71097/IJSAT.v16.i2.4934
Short DOI https://doi.org/g9kc6w
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