The project led by Astra Zeneca worth just over 1million in Innovate UK

and company funding was awarded by Innovate UK in the Formulated

Products : meeting the product and process design challenge competition .
The project is a collaboration between large UK pharmaceutical companies,
academia and technology suppliers to generate a structured approach to
designing age-appropriate medicines for children and technology for
predicting their quality and performance.

Background
Paediatric medicines is currently a hot topic within the pharmaceutical
industry and there is a lot of effort going into developing medicines that
are acceptable in terms of taste but also provide the relevant dose and
exposure required. Paediatric medicinal products are more complex than
their adult alternatives due to the need to cater for differences in
physiology and anatomy, whilst providing flexible dosing and tastemasking without impeding efficacy.
Regulatory guidance emphasises the need for age appropriate medicines
without providing formulation strategy direction so substantial effort is
needlessly duplicated across numerous pharmaceutical companies.
There are strong commercial incentives to shorten development times
within this high value manufacturing sector but rapid development is
hindered by the risk and cost to a single company.

Aims of Project

Astra Zeneca
(Lead partner)
Bristol Meyers Squibb
GlaxoSmithKline
Pfizer

Work stage 1

Work stage 2

Work stage 3

The aim of the project is to develop new analytical tools through an open
innovation consortium to provide a novel process to guide the deign and
selection of complex paediatric formulations enabling assessment of their
acceptability quickly and ensuring regulatory compliance.
This will provide a smarter route to
developing childrens medicines to
reduce costs and time of development
by determination of the most
appropriate testing strategies that drive
formulation design.
This will in turn provide a step change in
speed, cost and quality benefits for
paediatric formulation development
whilst ensuring a greater probability of regulatory and technical success in
an increasingly challenging environment.

Work stage 4

Expected outcomes and

benefits:

Aston University
University of Bath
University of
Birmingham
University College
London

SME company

Project partners
Universities and RTOs

Introduction

Large Pharma Companies

Accelerating Paediatric Formulation Development

Through Smart Design and Predictive Science

Molecular
Profiles
Ltd

Academy of
Pharmaceutical
Sciences

Develop novel in-vitro techniques based on current industrial and academic

understanding which have the potential to predict the taste of medicines.

Develop novel analytical and in-silico techniques to predict the in vivo and extent of
absorption of paediatric medicines in children.

Selection of existing UK based encapsulation technologies and model drugs

representative of chemical entities within the development pipelines of UK
Pharmaceutical companies

Determine patient needs in terms of acceptable formulation type with assessment

of appearance, taste and mouthfeel. Using conceptual prototypes and undertake
evaluation in a clinical setting to demonstrate end user acceptance

Work stage 5

Manufacture non- conventional formulation prototypes identified through

evaluations in WS3&4

Work stage 6

Final validation of the design pathway, analytical and in-silico tools to demonstrate
suitability for paediatric formulation development

Existing knowledge of paediatric

formulation development within the
UK is sparsely distributed amongst
large pharmaceutical companies,
SMEs and academia. The project will
act as a lever to enable this
knowledge to be pooled and bring
together the key groups in a non
competitive environment. This will in
turn avoid duplication of effort, allow
novel standardised test methods to be
developed thus expediting the R&D
process.
Establish the UK as the premier
centre for development of paediatric
medicines, increasing external and
internal investment, thereby boosting
the UK science base.
UK based, commercially available,
regulatory compliant pathway for
guiding
paediatric
formulation
development.
Although the project is focussed on
paediatric formulations there are
many other situations where dose
flexibility and taste masking are
required , for example in geriatrics,
head and neck cancer patients and for
other individuals where swallowing
can be an issue. Therefore the
technologies
and
strategies
developed could be applied to a
much wider market and clinical need.