Kolipaka, Siva S., Tabriz, Atabak Ghanizadeh, Garg, Vivek ORCID: https://orcid.org/0000-0002-8515-4759, Trivedi, Vivek ORCID: https://orcid.org/0000-0001-9304-9214 and Douroumis, Dennis ORCID: https://orcid.org/0000-0002-3782-0091 (2026) HME as a transformative platform in pharmaceutics: from molecular dispersion engineering to personalized drug delivery. International Journal of Pharmaceutics:127161. ISSN 0378-5173 (Print), 1873-3476 (Online) (doi:10.1016/j.ijpharm.2026.127161)

Preview

PDF (Open Access Preprint) 53926 GARG_HME_As_A_Transformative_Platform_In_Pharmaceutics_(OA PREPRINT)_2026.pdf - Published Version Available under License Creative Commons Attribution. Download (11MB) | Preview

Abstract

Hot melt extrusion (HME) has become a major continuous manufacturing approach for producing amorphous solid dispersions (ASDs) that address the poor solubility and limited bioavailability of many contemporary drug candidates. Through controlled application of heat and mechanical shear, HME enables uniform molecular dispersion of the drug within a polymer carrier, converting crystalline APIs into kinetically stable amorphous systems with improved dissolution profiles and enhanced supersaturation. The performance of these extrudates is determined by essential Critical Quality Attributes (CQAs) such as glass transition temperature (Tg), residual crystallinity, dissolution behaviour and impurity levels which in turn depend on Critical Material Attributes (CMAs) including polymer properties, drug loading, hygroscopicity and particle size, as well as Critical Process Parameters (CPPs) like screw speed, barrel temperature, residence time and specific mechanical energy (SME). A Quality by Design (QbD) framework provides a structured basis for formulation and process optimization by mapping the relationships between CQAs, CMAs and CPPs to establish a robust design space. Modern implementation strategies increasingly incorporate Process Analytical Technology (PAT) tools and real-time release testing (RTRT), allowing continuous monitoring of amorphization, mixing efficiency and chemical stability in alignment with FDA, EMA, and ICH regulatory expectations. Emerging case studies highlight the broad applicability of HME beyond traditional bioavailability enhancement, with successful use in taste-masked paediatric formulations, abuse-deterrent platforms, fixed-dose combinations (FDCs), and gastro-retentive systems. Together, these developments reinforce HME as a mature, solvent-free, and industrially scalable technology for manufacturing advanced oral drug products with consistently high performance and improved patient outcomes.

Item Type:	Article
Uncontrolled Keywords:	hot melt extrusion, amorphous solid dispersions, solubility, dissolution, 3D printing, scale-up
Subjects:	R Medicine > R Medicine (General) R Medicine > RS Pharmacy and materia medica T Technology > T Technology (General)
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > Medway School of Pharmacy Faculty of Engineering & Science > School of Engineering (ENG) Faculty of Engineering & Science > School of Science (SCI) Faculty of Engineering & Science > Wolfson Centre for Bulk Solids Handling Technology
Last Modified:	07 Jul 2026 14:06
URI:	https://gala.gre.ac.uk/id/eprint/53926

Actions (login required)

View Item

Downloads