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Title: Enhancing the understanding of palatability assessment used in the development of paediatric medicines
Author: Keeley, Alexander Joseph
ISNI:       0000 0004 8507 9976
Awarding Body: UCL (University College London)
Current Institution: University College London (University of London)
Date of Award: 2019
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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.
Supervisor: Tuleu, C. ; Orlu, M. ; Ernest, T. Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available