SPaeDD-UK: Smart Paediatric Drug Development - UK Accelerating paediatric formulation development
An open innovation R&D project -
The ambition of the Consortium was to establish an industry standard framework and suite of tools to develop safe and efficacious paediatric dosage forms. The output and agreed tools are detailed below with links to any relevant peer-reviewed publications:
An additional tool developed as part of the research activities in WS4 was a pragmatic, reliable acceptability assessment questionnaire from a field based ‘ACCEPT’ study. The tool recommended is the 5-point hedonic scale (see below) with a mean hedonic score of ≤3 (neutral or positive face) and <60% of participants responding “no” to the question, “Did you think the medicine tasted OK?” together with a simple check that the child took the medicine as intended and did not spit out or vomit the dose. For further information, please click here
- Taste evaluation
- Prediction of human exposure in children
- Taste Masking and technology platforms for paediatric medicines
- Acceptability testing
An additional tool developed as part of the research activities in WS4 was a pragmatic, reliable acceptability assessment questionnaire from a field based ‘ACCEPT’ study. The tool recommended is the 5-point hedonic scale (see below) with a mean hedonic score of ≤3 (neutral or positive face) and <60% of participants responding “no” to the question, “Did you think the medicine tasted OK?” together with a simple check that the child took the medicine as intended and did not spit out or vomit the dose. For further information, please click here
This project focussed on creating a development pathway comprising a tool box of testing methodologies (in-vitro, in-vivo and in-silico techniques) for predicting taste, drug release and human exposure in paediatric patients. The project was co-funded by Innovate UK, the UK's innovation agency.
These tools could be used to help select the most appropriate formulations to support the development and commercialisation of paediatric pharmaceutical products. It is anticipated that the outputs of the project will be leveraged to provide a commercially available service to appropriately evaluate and help accelerate development of paediatric dosage forms.
These tools could be used to help select the most appropriate formulations to support the development and commercialisation of paediatric pharmaceutical products. It is anticipated that the outputs of the project will be leveraged to provide a commercially available service to appropriately evaluate and help accelerate development of paediatric dosage forms.