Orubu, ESF; (2016) Flexible Solid Oral Dosage (FSOD) forms as the preferred formulations for children. Doctoral thesis , UCL (University College London).

Abstract

The lack of suitable formulations for children globally leads to manipulation of adult medicines that pose quality, safety, and efficacy concerns. In developing countries, poor access to medicines leads to deaths from treatable diseases. In 2008, the World Health Organisation (WHO) proposed Flexible Solid Oral Dosage (FSOD) forms, medicines which can either be swallowed intact as solids or dispersed in water at the point of administration, for example dispersible tablets, as the preferred formulations for children, especially in developing countries. If feasible, this would potentially improve access to age-appropriate medicines for children. This work examined the viability of the WHO’s proposal from the perspectives of needs, acceptability, and manufacturability using Nigeria as a model of a developing country. It surveyed selected countries to determine therapeutic needs; and end-users to identify issues with the use of the dispersible tablet. An assessment of the direct-compression manufacturability of oral essential medicines was performed; and a directly-compressible platform for the production of dispersible tablets was demonstrated using four model active pharmaceutical ingredients: caffeine citrate, furosemide, paracetamol and zinc sulfate. In a proof-of-concept study, milk was assessed as a novel excipient in dispersible tablets: and the taste-masking ability of infant formula was assessed in a human taste panel. The study found that, while there are challenges, capacity exists locally for the direct-compression (DC) production of dispersible tablets. Cardiovascular and anti-infective medicines were identified as priority needs. A platform suitable for the DC production of dispersible tablets was identified. Caregivers perceived the dispersible tablet as easy-to-use. The results suggested that the infant formula assessed may have weak taste-masking ability. Overall, these results suggest that the WHO proposal of FSOD forms as the preferred formulations for children is a viable modality to increase access to age-appropriate medicines for children under the age of 5 years.

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