An overview of the Work Packages that are being performed by academics and industry in a novel collaborative effort in paediatrics R&D is given below:
Work Stream 1: To develop in-vitro techniques based on current industrial and academic understanding, which have the potential to predict the taste of medicines, following re-manufacture/sourcing of formulations where taste data exists. Efforts will be focussed on translating these tests into user friendly industrially applicable tools. Once developed and refined to a suitable standard through manufacture and testing of existing products from selected pharamceutical companies, the predictability of these techniques will be further tested by evaluating prototype formulations manufactured in WS5.
Work Stream 2: To develop analytical and in silico techniques to predict the in vivo rate and extent of absorption of paediatric medicines in children based on fundamental understanding from recent academic activities. Similarly to WS1, tools will be developed using existing products and model compounds, with subsequent testing, refinement and validation being conducted using prototype formulations (WS5).
Work Stream 3: Selection of existing regulatory acceptable UK-based encapsulation technologies and model drugs that are representative of chemical entities within the development pipelines of UK large Pharma. Further characterisation of the physico-chemical properties of these model drugs will be required to improve understanding of factors that may influence taste/taste masking; for example materials properties of the drug substance, encapsulation and correlation of microstructural characteristics to drug product performance. Funding currently supports up to 5 technologies and up to 5 drugs (=total 25 prototypes).
Work Stream 4: Determine patient needs in terms of acceptable formulation type (based on availability of suitable formulations similar to those selected in WS3 and 5) with assessment of appearance, taste and mouthfeel . This will use conceptual prototypes and undertake evaluation in a clinical setting to demonstrate end user acceptance to progress technologies to TRL7.
Work Stream 5: Manufacture non-conventional formulation prototypes identified through evaluations stated in Work Stream 3 and 4 at pilot scale.
Work Stream 6: Final validation of the design pathway, analytical and in-silico tools to demonstrate suitability for use paediatric formulation development.
Work Stream 1: To develop in-vitro techniques based on current industrial and academic understanding, which have the potential to predict the taste of medicines, following re-manufacture/sourcing of formulations where taste data exists. Efforts will be focussed on translating these tests into user friendly industrially applicable tools. Once developed and refined to a suitable standard through manufacture and testing of existing products from selected pharamceutical companies, the predictability of these techniques will be further tested by evaluating prototype formulations manufactured in WS5.
Work Stream 2: To develop analytical and in silico techniques to predict the in vivo rate and extent of absorption of paediatric medicines in children based on fundamental understanding from recent academic activities. Similarly to WS1, tools will be developed using existing products and model compounds, with subsequent testing, refinement and validation being conducted using prototype formulations (WS5).
Work Stream 3: Selection of existing regulatory acceptable UK-based encapsulation technologies and model drugs that are representative of chemical entities within the development pipelines of UK large Pharma. Further characterisation of the physico-chemical properties of these model drugs will be required to improve understanding of factors that may influence taste/taste masking; for example materials properties of the drug substance, encapsulation and correlation of microstructural characteristics to drug product performance. Funding currently supports up to 5 technologies and up to 5 drugs (=total 25 prototypes).
Work Stream 4: Determine patient needs in terms of acceptable formulation type (based on availability of suitable formulations similar to those selected in WS3 and 5) with assessment of appearance, taste and mouthfeel . This will use conceptual prototypes and undertake evaluation in a clinical setting to demonstrate end user acceptance to progress technologies to TRL7.
Work Stream 5: Manufacture non-conventional formulation prototypes identified through evaluations stated in Work Stream 3 and 4 at pilot scale.
Work Stream 6: Final validation of the design pathway, analytical and in-silico tools to demonstrate suitability for use paediatric formulation development.
