About GRiP Work Package 5
So far, there has been little sharing of best practices between formulation scientists and paediatric drugs research experts. This lack of communication and sharing of experiences in this area acts as a significant hindrance to adequacy of paediatric medicine. Experience has shown that lack of awareness in formulation issues by paediatric researchers leads to many problems in clinical trials; at the same time formulation education and research has been traditionally provided by formulation scientists who do not usually have paediatric clinical pharmacy and pharmacology training and have little or no awareness of the challenges (such as palatability, acceptability and dosage form issues) of administering medicines to children.
Thus, sharing best practices worldwide is of the utmost importance for translational paediatric drug delivery not only in trials, but also in practice later on. To help meet this demand, a series of tasks is foreseen as part of WP5. The WP5 team will provide a valuable International Paediatric Formulation Knowledge Platform to share knowledge, expertise and experience around paediatric drug delivery as well as pharmaceutical issues in clinical trials and in practice worldwide.
Through various research initiatives, WP5 aims to identify situations in which access to age-appropriate formulations of medicines is difficult (particularly in children under five) and to subsequently plan and develop formulation strategies that will improve access in all countries. Also support for paediatric formulation education and training worldwide will be organised, as appropriate tailor made education programmes are needed for both experts in formulations and paediatric clinical researchers.
Please browse through the archive of WP5 deliverables on the WP5 Results page.
Overview of GRiP work on Paediatric formulations (WP5)
Currently the WP5 team is working on the following five areas:
1. Networking - focuses on an interactive map showing names and contact details of international formulation experts, divided by WHO region. Also includes a "meet the expert" section, where users can access webinars on formulations.
2. Pharmaceutical excipients - focuses on a list of online and offline resources on excipients
3. Minimizing the risks & alternatives to compounding formulation for paediatrics - focuses on a list of online and offline resources on excipients.
4. Education and Training - focuses on a list of educational resources on formulations.
5. Research - focuses on a list and information of all the relevant studies and projects that GRiP researchers are involved in.
You can also browse a list of links and articles on Paediatric Formulations here - WP5 Links of interest.
Key Tasks & Deliverables
1. Establishing and maintaining an International Paediatric Formulation Knowledge Platform
• By harmonisation of research tools specific for palatability and acceptability assessment of dosage form in children.
• By providing support to allow a wider membership of academics, relevant practitioners and industry partners to be connected globally.
2. To be involved in relevant tasks such as the STEP database (Safety and Toxicity of Excipients for Paediatrics) initiated under the auspices of EuPFI (European Paediatric Formulation Initiative) in collaboration.
3. Providing formulation education for scientists and clinicians
• Online modules carried out in the framework of WP1 but not only.
• Regional training in collaboration with global stakeholders such as WHO and International Pharmaceutical Federation (FIP).
4. Facilitating global paediatric formulation research worldwide
• Pilot strategies to improve development and access to age-appropriate formulations, particularly in children under WP5.
• Scoping of unlicensed medicines in children in resource poor settings to better understand regional use and problems with extemporaneous formulations and propose ways forward.
• Expand research into Neonatal Exposure to Excipients Globally, in less regulated countries.
• By involving patient and family (from different background) preferences in formulation research in collaboration with VSOP-EGAN.
• Through series of proof of concept papers on innovative/alternative drug delivery technologies for children.