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Defining end-user acceptability attributes of orodispersible films for patient centricity

Scarpa, Mariagiovanna; (2019) Defining end-user acceptability attributes of orodispersible films for patient centricity. Doctoral thesis (Ph.D), UCL (University College London). Green open access

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Abstract

Poor acceptability has been associated with low compliance, particularly in special patient populations. Patient acceptability assessment of individual dosage form attributes offers the advantage of providing information to the manufacturer on the strategy to adopt for optimising the dosage form design at an early drug product development stage. The development of in vitro methods capable of predicting attribute acceptability based on the quantitative measurement of relevant formulation variables could provide the manufacturer with a decision-supporting toolkit to guide the development of acceptable drug products. However, there is a great need of defining standard methodologies for the assessment of patient acceptability as the current knowledge is fragmented in this field. The orodispersible film (ODF) platform is considered patient-centric, however its attributes have rarely been assessed for acceptability on an individual basis. The aims of this study are to identify key acceptability attributes of the ODF platform by in vivo methods, and to develop and optimise in vitro methods to predict acceptability. ODF placebo samples differing in specific formulation variables were prepared and the corresponding acceptability attributes were assessed by human panel. Only some attributes differed among samples in the human panel study, and therefore were identified as key acceptability attributes. A series of in vitro methods for the prediction of ODF attribute acceptability were developed and optimised, and the same sample set was tested. In vitro methods were considered predictive if the measured variable directly or indirectly correlated with the in vivo acceptability assessment. Application of the proposed strategy in the acceptability assessment of oral dosage forms was shown, and key acceptability attributes (stickiness, disintegration time) and in vitro predictive methods (dynamic mechanical analysis, mechanical oral cavity model) were identified for the ODF platform.

Type: Thesis (Doctoral)
Qualification: Ph.D
Title: Defining end-user acceptability attributes of orodispersible films for patient centricity
Event: UCL (University College London)
Open access status: An open access version is available from UCL Discovery
Language: English
Additional information: Copyright © The Author 2019. Original content in this thesis is licensed under the terms of the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Any third-party copyright material present remains the property of its respective owner(s) and is licensed under its existing terms.
Keywords: Patient-centric, Orodispersible films, Acceptability, Formulation
UCL classification: UCL
UCL > Provost and Vice Provost Offices
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
URI: https://discovery.ucl.ac.uk/id/eprint/10077541
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