Design and process parameter evaluation of bilayer capsule systems for targeted ileal drug delivery

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dc.contributor.authorMillet, Elisa
dc.contributor.authorVandenbroucke, Sofie S. T.
dc.contributor.authorO’Shea, Joseph P.
dc.contributor.authorGriffin, Brendan T.
dc.contributor.authorJannin, Vincent
dc.contributor.funderHorizon Europe
dc.date.accessioned2026-07-14T08:50:07Z
dc.date.available2026-07-14T08:50:07Z
dc.date.issued2026-07-04
dc.description.abstractThe dynamic and transitory nature of the distal small intestine makes targeted drug delivery to this region particularly challenging. This study aimed to develop a bilayer capsule system for site-specific drug release in the terminal ileum. The capsules consisted of an inner water-soluble layer based on hydroxypropyl methylcellulose (HPMC) and pullulan, combined with an outer ethylcellulose layer incorporating sodium alginate as a pore-forming agent. The influence of alginate concentration and curing conditions (temperature and relative humidity) on capsule structure and performance was systematically investigated. Thermal analysis by differential scanning calorimetry guided plasticizer selection and curing parameters. Capsule morphology and surface properties were characterized by scanning electron microscopy and roughness analysis, while functional performance was evaluated through disintegration, water ingress, and dissolution studies under sequential pH conditions simulating the gastrointestinal tract. Alginate concentration significantly influenced surface morphology and permeability of the outer layer, whereas curing conditions modulated film cohesion and porosity. Lead formulations (4–6% alginate, cured at 70 °C and 40% RH) exhibited low water ingress under acidic conditions, maintained capsule integrity, and enabled delayed release at pH 7.4. Compared with reference enteric capsules (Capsugel® Enprotect® capsules), these systems showed a delayed release profile, with potential for targeting of the distal ileum. Overall, this study highlights the critical role of formulation and process parameters in controlling capsule microstructure and provides a robust platform for site-specific oral drug delivery to the distal small intestine.en
dc.description.sponsorshipHorizon Europe|HORIZONsingle bondHLTH-2021-TOOL-06, GA 101,057,491
dc.description.versionPublished Version
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid107601
dc.identifier.authororcidMillet, Elisa
dc.identifier.authororcidVandenbroucke, Sofie S. T.
dc.identifier.authororcidO’Shea, Joseph P.§0000-0001-9461-8730
dc.identifier.authororcidGriffin, Brendan T.§0000-0001-5433-8398
dc.identifier.authororcidJannin, Vincent
dc.identifier.citationMillet, E, Vandenbroucke, S S T, O’Shea, J P, Griffin, B T & Jannin, V 2026, 'Design and process parameter evaluation of bilayer capsule systems for targeted ileal drug delivery', European Journal of Pharmaceutical Sciences, vol. 224, 107601, pp. 1-13. https://doi.org/10.1016/j.ejps.2026.107601
dc.identifier.doi10.1016/j.ejps.2026.107601
dc.identifier.endpage13
dc.identifier.issn0928-0987
dc.identifier.journaltitleEuropean Journal of Pharmaceutical Sciences
dc.identifier.othercrossref: 10.1016/j.ejps.2026.107601
dc.identifier.otherORCID: /0000-0001-9461-8730/work/220716362
dc.identifier.otherORCID: /0000-0001-5433-8398/work/220716509
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19064
dc.identifier.volume224
dc.language.isoen
dc.publisherElsevier B.V.
dc.relation.urihttps://www.scopus.com/pages/publications/105043940673
dc.rights© 2026, the Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ).
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.statusPeer reviewed
dc.subjectBilayer capsule
dc.subjectDelayed release
dc.subjectDrug delivery
dc.subjectEthylcellulose
dc.subjectIleal targeting
dc.subjectSodium alginate
dc.subject[Pharmacy]
dc.titleDesign and process parameter evaluation of bilayer capsule systems for targeted ileal drug deliveryen
dc.typeArticle (peer-reviewed)
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