From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals
Vyas, J., Raytthatha, N. (2025). From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals. EKB Journal Management System, (), -. doi: 10.21608/bfsa.2025.353751.2408
Jigar R Vyas; Nensi Raytthatha. "From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals". EKB Journal Management System, , , 2025, -. doi: 10.21608/bfsa.2025.353751.2408
Vyas, J., Raytthatha, N. (2025). 'From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals', EKB Journal Management System, (), pp. -. doi: 10.21608/bfsa.2025.353751.2408
Vyas, J., Raytthatha, N. From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals. EKB Journal Management System, 2025; (): -. doi: 10.21608/bfsa.2025.353751.2408

From Concept to Delivery: The Evolution and Applications of Hot-Melt Extrusion in Pharmaceuticals

Bulletin of Pharmaceutical Sciences Assiut University
Articles in Press, Accepted Manuscript, Available Online from 28 April 2025  XML
Document Type: Review Article
DOI: 10.21608/bfsa.2025.353751.2408
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Authors
Jigar R Vyas email orcid 1; Nensi Raytthathaorcid 2
1Krishna School of Pharmacy & Research, Vadodara-Mumbai National Highway 8, Vadodara, Gujarat 391240
2Gujarat Technological University, Ahmedabad, Gujarat 382424, India
Abstract
Hot Melt Extrusion (HME) is an innovative approach that is currently receiving significant interest in the pharmaceutical sector for the manufacturing of various dosage forms. This technique entails the melting and extruding of a mixture of pharmaceutical drugs and polymeric carriers, resulting solid dispersions or more sophisticated formulations. This review examines the historical development of HME, its foundational applications in pharmaceutical manufacturing. It also provides an overview of type of extruders used for hot melt extrusion and analyzes the essential extrusion parameters that affect the qualities of the product. Furthermore, it analyzes the variety of materials appropriate for HME, including both active pharmaceutical ingredients and polymeric carriers. HME is not only a validated manufacturing method but also aligns with the objectives of the US Food and Drug Administration's (FDA) process analytical technology (PAT) framework for the design, analysis, and control of production through quality control metrics throughout the active extrusion process. From comprehensive viewpoint, hot-melt extrusion technology, encompasses its components, processing technologies, materials, and innovative formulation designs and advancements in many applications for oral drug delivery system.
Keywords
Screw extruders; manufacturing; solubility; bioavailability; extrusion
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