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Enhancing the understanding of palatability assessment used in the development of paediatric medicines

Keeley, Alexander Joseph; (2019) Enhancing the understanding of palatability assessment used in the development of paediatric medicines. Doctoral thesis (Ph.D), UCL (University College London). Green open access

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Abstract

Children are averse to unpalatable medicines. A medicine will only elicit its desired effect if it is taken by the patient, therefore unpalatable medicines threaten the effective treatment of paediatric indications. Regulators thus now require all new medicines to have associated plans for paediatric formulation development; key to which is palatability testing. Therefore, there is a real need to enhance our understanding of the nascent area of pharmaceutical palatability testing. Much of this research has focused on the rat brief access taste aversion (BATA) model, which uses water-deprived rats to evaluate aversiveness of a given sample by counting the number of rat licks relative to water and has the distinct advantage of being used preclinically due to the absence of human participants. The overall aims of this research were to: explore the methodological limitations of promising palatability assessment methodologies; expand the formulation repertoire and push the limits of the BATA model; and leverage the data from the BATA model to minimise animal use. Our understanding of pharmaceutical palatability testing has been enhanced. Key questions such as the number of participants necessary for a human pharmaceutical taste panel are now known. The limits of the BATA model have been explored, and we now know that it can provide information on mouthfeel as well as taste, enabling assessment of more complex liquid oral dosage forms such as suspensions. Furthermore, by leveraging the data from the BATA model, a methodology for assessing solid oral dosage forms and an in silico model for prediction of palatability were developed. This work has both answered and yielded questions and more work is need to improve pharmaceutical palatability assessment and thus children’s medicines. However, it is clear we are on a path towards more palatable children’s medicines and thus more effective treatment of paediatric diseases.

Type: Thesis (Doctoral)
Qualification: Ph.D
Title: Enhancing the understanding of palatability assessment used in the development of paediatric medicines
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. Access may initially be restricted at the author’s request.
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/10086871
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