Prof Tuleu presents CloSed formulation development at APS course
On 20 March 2018, Prof Catherine Tuleu from University College London (ULC) held a presentation at the Loughborough University, during the Academy of Pharmaceutical Sciences (APS) residential course on Current Regulatory trends and updates in parenteral drug product development. This was aimed at pharmaceutical scientists and regulatory professionals involved in the development, manufacture, control or registration of parenteral products. Speakers included key industry and MHRA experts.
The APS is the UK-based professional membership body for Pharmaceutical Scientists. It represents individuals and organisations from around the globe, throughout their development, in the delivery of excellence in the Pharmaceutical Science sector.
Catherine is professor in paediatric pharmaceutics and is an expert of paediatric drug delivery systems including in vitro, animal and clinical evaluation. She is involved in the clonidine pharmaceutical development in the CloSed project.
During the presentation entitled ‘The development of age-appropriate dosage forms for parenteral administration: a case study with clonidine (the FP7 CloSed Project)’, she discussed the CloSed study, as an example of paediatric clinical trial aimed at studying a new formulation appropriate for children.
She introduced the regulatory setting provided an overview of the use of medicines in Paediatric Intensive Care Units and CloSed study, including aims and expected outputs, challenges from the methodological point of view, the main items of the Paediatric Investigation Plan (PIP) and considerations regarding the formulation development, the blinding and randomisation, the product labelling, shipment and the Investigational Medicinal Product (IMP) and Paediatric-Use Marketing Authorisation (PUMA) requirements.
By presenting CloSed data, the presentation addressed practical considerations and challenges related with the pharmaceutical development of paediatric medicines and paediatric clinical trial, including appropriate strength selection and the development of a suitable dosing regimen that maintains the integrity of a double-blinded study design.
The presentation is available here.