ABSTRACT

The lack of age-appropriate (paediatric) authorised medicines is a long-standing problem amongst regulatory authorities, patients, parents and prescribers. This is driven by the paucity of information on clinical efficacy, deficiency in safety data (i.e. biopharmaceutics) and the lack of quality information such as palatability and acceptability data in children. To counteract this deficiency bespoke, unlicensed formulations are formulated by contract manufacturers, hospitals and dispensing pharmacists using a variety of ‘recipes’ and differing manufacturing protocols.

In this work, Morphological Analysis as a problem structuring method is deployed using key stakeholders of the problem complex. This method, developed from operational research and design thinking sectors, has the ability to structure and parameterise a complex problem to isolate a smaller subset of an internally consistent solution space for the design of experiments. Hence, Morphological Analysis is used experimentally to decide which pharmaceutical dosage forms of furosemide would be selected as a solution space for paediatric patients with low cardiac output syndrome. Morphological Analysis application resulted in the selection of two different dosage forms for further work (Microemulsion oral liquid dosage form and an Oro-dispersible Mini-tablet).