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Characterisation and sensory evaluation of placebo OrPhylloTM orodispersible films as a versatile paediatric drug delivery platform

Dziemidowicz, Karolina; Jin, Jiao; Ranmal, Sejal R; Piumpongsuk, Sirakarn; Aspinall, Samuel; Serpell, Christopher J; McCann, Conor; (2025) Characterisation and sensory evaluation of placebo OrPhylloTM orodispersible films as a versatile paediatric drug delivery platform. Drug Development and Industrial Pharmacy pp. 1-15. 10.1080/03639045.2025.2521664. (In press). Green open access

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Abstract

Orodispersible films (ODFs) are a convenient form of paediatric drug delivery and for those with swallowing difficulties. They can be extemporaneously prepared in pharmacies using pre-formulated bases which simplify and fasten the process while reducing compounding errors. OrPhylloTM is a water-based commercial vehicle for preparing polymeric ODFs. It is chemically compatible with various clinically relevant active pharmaceutical ingredients (APIs) at different drug loadings.This study focuses on characterising placebo OrPhylloTM films, including their morphological, mechanical, and textural properties, as well as physicochemical stability by thermal analysis and X-ray diffraction. After local ethical approval, healthy adults explored stickiness, mouthfeel, and disintegration of these 3 × 3cm ODFs following various modes of administration.OrPhyllo™ ODFs (185 ± 10µm thick) exhibited distinct surface characteristics, one side (lower) smoother and the upper side rougher, as observed and shown by scanning electron and atomic force microscopy. However, both sides demonstrated similar mucoadhesive properties and rapid disintegration (between 60 and 140s, depending on the method used). Both sides were well-accepted, whether administered on the tongue or in the cheeks, with minor differences in mouthfeel and fast disintegration perception. The hen's egg chorioallantoic membrane test showed no irritancy, supporting the good acceptability of these placebo ODFs. The films remained structurally stable over 6 months, with low residual moisture.

Type: Article
Title: Characterisation and sensory evaluation of placebo OrPhylloTM orodispersible films as a versatile paediatric drug delivery platform
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/03639045.2025.2521664
Publisher version: https://doi.org/10.1080/03639045.2025.2521664
Language: English
Additional information: © 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.
Keywords: administration, extemporaneous, irritancy, orodispersible, orphyllo, palatability, rapid disintegration, thin films
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharma and Bio Chemistry
URI: https://discovery.ucl.ac.uk/id/eprint/10210631
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