Amin, Divya; (2024) Taste masking paediatric medicines using crystal engineering. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

Medication compliance is reliant on a myriad of properties, one being taste. Oral solids when ingested, interact with receptor cells in the oral cavity, leading to either a positive or negative reaction by the patient. Currently, many active pharmaceutical ingredients (APIs) exhibit a bitter taste that often results in poor acceptability of a medicine. Taste is an organoleptic property that is often neglected during commercial development of paediatric oral dosage forms. A signi cant number of medicines on the World Health Organisation’s (WHO) ‘list of essential medicines for children’ exhibit an unpleasant taste. During pre-formulation development, there is no consistent guideline on what acceptable taste improving ingredients are, leading to excessive use of inappropriate excipients. Although recent advances in pharmaceutical research have led to commercialisation of cocrystals, development of paediatric medicines with improved taste using crystal engineering is relatively nascent. Current research e orts are focused on developing crystal engineering approaches to improve bitter drug molecules commonly used in paediatric oral formulations. These approaches rely on the construction of multi-component crystals involving bitter tasting APIs and carefully selected taste-masking agents. Here studies are presented on a triad of crystal engineering activities undertaken to tackle the task of improving the bitter taste of paediatric APIs. Our approach to designing crystals entails using statistical analysis to aide experimental approaches in preparing multicomponent crystals. Results yielded from analyses are presented to demonstrate both the progress made in crystal engineering strategies as well as highlighting knowledge gaps that are present when preparing such materials. A handful of the novel multicomponent solids prepared were also used in in vivo taste assessments to determine whether taste had improved or not. The culmination of both solid-state approaches as well as in vivo testing has allowed us to develop a reformed development strategy for paediatric APIs destined for oral consumption

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