Kolipaka, Siva S., Junqueira, Laura A., Garg, Vivek ORCID: https://orcid.org/0000-0002-8515-4759, Bhatt, Shaumil, Trivedi, Vivek ORCID: https://orcid.org/0000-0001-9304-9214 and Douroumis, Dennis ORCID: https://orcid.org/0000-0002-3782-0091 (2026) Novel hybrid polymer-lipid-based formulations for enhanced dissolution rates of poorly water-soluble drugs: a Quality by Design (QbD) approach via hot melt extrusion. AAPS PharmSci Tech, 27:267. ISSN 1530-9932 (Online) (doi:10.1208/s12249-026-03530-3)

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Abstract

This study presents a Quality by Design (QbD) strategy combined with Design of Experiments (DoE) to develop hybrid polymer–lipid hot-melt extruded (HME) formulations aimed at improving the dissolution rate and palatability of ibuprofen (IBU), a Biopharmaceutics Classification System (BCS) Class II drug with poor aqueous solubility. A fractional factorial design was applied to evaluate the influence of Eudragit EPO and Gelucire 48/16 (GLC) ratios on the preparation of IBU-loaded extrudates. Physicochemical characterisation of the micronised extrudates, using differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD), confirmed the formation of amorphous solid dispersions (98.0–99.8%). The DoE analysis demonstrated that the EPO/GLC ratio significantly affected crystallinity, particle size distribution, and dissolution performance. The optimised hybrid polymer–lipid formulations exhibited immediate drug release (> 80%) within 45 min. Furthermore, in vivo evaluation indicated effective taste masking and improved palatability.

Item Type:	Article
Additional Information:	Open access funding provided by the Cyprus Libraries Consortium (CLC).
Uncontrolled Keywords:	amorphous solid dispersions, hot melt extrusion, lipid-based formulation, quality by design, taste masking
Subjects:	R Medicine > RS Pharmacy and materia medica T Technology > T Technology (General) T Technology > TP Chemical technology
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > School of Engineering (ENG) Faculty of Engineering & Science > Wolfson Centre for Bulk Solids Handling Technology
Last Modified:	07 Sep 2026 11:20
URI:	https://gala.gre.ac.uk/id/eprint/54352

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