01 Feb 2018
William Marks was awarded a 2017 Messel Travel Bursary to attend the 9th conference of the European Paediatric Formulation Initiative in Warsaw, Poland, in September 2017. William is a PhD student at the University of Cambridge. Here he describes how his attendance was a great opportunity to discuss his work, meet major academics and up-and-coming researchers in the field of paediatric formulations.
‘The SCI Messel Award Bursary was instrumental in providing the resources necessary to allow me to attend the 9th conference of the European Paediatric Formulation Initiative in Warsaw, Poland, in September 2017. This conference was one of the most ideal opportunities to discuss my work, meet major academics and up-and-coming researchers in the field of paediatric formulations, and brainstorm and network with individuals from major pharmaceutical companies and regulatory bodies.
'My work focuses on developing a device to deliver medicines to breastfeeding infants. The aim of the device is to deliver a full dose of medication to an infant within the time and volume constraints of a single breastfeed. This device is designed with the aim to not only encourage breastfeeding, which the WHO recommends exclusively for the first six months of life, and complementarily for the first two years, but also to help decrease the incidence of infant mortalities worldwide. According to the WHO, in 2013, 6.3 million children under the age of five died worldwide, with more than half of those fatalities resulting from preventable or treatable conditions that require simple affordable interventions. 74% of these mortalities, or 4.6 million, occurred during infancy (within the first year). Breastfeeding, which has been deemed the single largest impact on child mortality of any intervention, could have also saved the lives of more than 800,000 children. To date, fewer than 40% of infants up to six months of age are exclusively breastfed, so there is significant room for improvement in promoting breastfeeding, which is a massive problem that could be solved by use of this device.
'Much of my work thus far has previously focused on actual device design, validation testing, and the understanding of device functionality, but to successfully develop this device so it is ready for clinical trials and real-world usage, it is essential to consider other aspects of the solution, including the dosage forms that are to be used in the device. Recent WHO, European Union, and US Food and Drug Administration policies towards paediatric dosage forms have changed significantly. Historically, the only dosage form widely considered an option for the paediatrics under the age of six were liquid oral dosage forms. However, the consideration of all paediatrics as a unified age group with the same needs is quickly being altered, with researchers and regulatory bodies taking to heart the vast physiological and developmental differences between neonates (0-30 days), infants (1-24 months), very young children (2-6 years), young children (6-12 years), and adolescents (12-18 years). Each of these age groups has very different requirements for sizes of doses and suitability of various dosage forms based on the ability to consume certain foods, swallow, or express feelings and concerns about prescribed medicines. Furthermore, the development of the gastrointestinal tract is a continuous progression, which alters the bioavailability equivalence of doses across age bands. While oral liquids were previously considered the dosage form of choice because they were easily swallowed and the dose could be easily adjusted, oral liquids exhibit poorer stability, often require refrigeration, require careful measurement to ensure accurate dosing, often require custom compounding, and are generally more expensive to produce. Due to the developments of new multiparticulate solid oral dosage forms, including minitablets and orally disintegrating dosage forms, solid oral dosage forms, which are significantly cheaper to produce with significantly better stability, are now being considered as preferred dosage forms for paediatrics as young as neonates and infants. As such, this conference focused on the issues surrounding various dosage forms and their respective suitability for various paediatrics, enhancing my knowledge on the topic and providing insights into the brightest minds in the field of paediatric formulations.
'In addition to considering the dosage forms themselves, it is essential to consider what ingredients are used, how the dosage form affects functionality of the device, and how formulation can be used to the advantage of the device. Many excipients that are traditionally used, including colors and stabilizers, have been shown recently to be toxic to neonates and infants. As such, it is essential that everything from the active ingredient to each and every excipient is studied, evaluated, and considered with regard to the safety of the patient. There is much left to discover within this field, with significant progress being made every day by researchers at the conference. This opportunity allowed me to truly grasp the magnitude of even seemingly minor choices when it comes to medications, and the magnitude of effect of all considerations involved. I was able to meet many of the international players all in one location, and develop relationships that will be key for future collaborations.
'My career aspirations include continuing to develop medical devices using a holistic approach, identifying key areas of research and not losing sight of the end goals while searching for answers to each individual question. This involves collaborating with a large number of individuals who each have unique specialties and experiences, and managing the project as a whole. The entire process of my PhD, including all the knowledge, relationships, and skills gained from attending this conference, will be essential to my future success in this field, and I am incredibly grateful to SCI for this opportunity to attend the European Paediatrics Formulation Initiative Conference. I look forward to continuing the work I love, which hopefully will bring improved health outcomes to millions of children and their families in years to come.’
William Marks
PhD Student
University of Cambridge
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