Ranmal, SR; (2015) Acceptable medicines for children: End-user insights to support dosage form design. Doctoral thesis , UCL (University College London).

Abstract

Evolving regulatory reforms have strengthened the global focus towards developing age- appropriate and acceptable formulations for paediatric patients. The European Medicines Agency (EMA) also mandates that acceptability of paediatric preparations should be evaluated with children as an integral part of pharmaceutical and clinical development. A review of literature highlights the current paucity of evidence to support the development of dosage forms that are suitable for children of different ages and health backgrounds. Important knowledge gaps also exist in the methodological considerations for conducting acceptability studies. The overall aim of this research was to determine the attitudes, preferences and behaviours of children, caregivers and healthcare professionals towards solid oral dosage forms. Age- adapted questionnaires were systematically developed and pre-tested in collaboration with young people, in keeping with the principles of patient and public involvement in research. A diverse sample of 590 school children and adolescents and over 400 caregivers were surveyed in hospitals, community pharmacies and schools. Attitudes towards dosage forms differed primarily based on age and prior use. Precedence for chewable dosage forms and tablets was identified, while capsules and multiparticulates administered with food were less acceptable. Another aspect of the research identified the prevalence of swallowing difficulties in healthy young adults. These participants showed a preference for taking two smaller dosage forms over a larger size, and for capsules over tablets. In an acceptability trial with placebo capsules, over 95% of young adults were able to swallow size #1 capsules. The inclusion of flavour had variable effects on acceptability . Healthcare professionals showed reservations towards solid oral dosage forms and many favoured liquid medicines for paediatrics. This thesis highlights the gap between regulatory expectations, industrial feasibility and clinical ideals. This should be addressed, to ensure that legislative reforms and global initiatives will have a positive impact on paediatric therapeutics in practice.

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