“Would the implementation of 3D printing of medicines be acceptable in children undergoing cancer treatment to help to improve adherence, compared to conventional dose forms?”

Background Current pharmaceutical manufacturing processes produce medications in fixed doses and forms, which do not account for individual patient variability in drug response, particularly in children. This results in frequent off-label drug manipulation, posing significant risks including inaccurate dosing, adverse reactions, and low treatment adherence. Recent advances suggest that 3D printing could offer a viable solution for creating personalized, child-friendly medications, thereby addressing these issues. However, very little is known about the feasibility and acceptability of 3D-printed formulations among children with cancer and their carers. Research Question Is the implementation of 3D-printed medications feasible and acceptable for children undergoing cancer treatment? Aims and Objectives Aim: To establish the feasibility of manufacturing 3D-printed tablets in a hospital pharmacy and assess their acceptability to paediatric cancer patients, their carers, and healthcare professionals. Objectives: To identify unmet needs regarding oral cancer medications in paediatric oncology. To develop laboratory methods for 3D-printing personalized doses. To validate 3D-printing methods in a hospital pharmacy setting. To compare the integrity of 3D-printed products with alternative methods. To evaluate acceptability of 3D-printed tablets in children. To compare costs of 3D-printed tablets with current practices. Methods The study will be conducted in four work packages (WPs): WP1: Surveys with children, their families, carers, and healthcare professionals to identify unmet needs and prioritize drugs for 3D printing. WP2: Content uniformity analysis to evaluate the accuracy of splitting tablets via High-Performance Liquid Chromatography. WP3: Installation and validation of a 3D printer in a hospital pharmacy, production of batches after comprehensive operator training, and comparison of costs of production with current practices. WP4: Implementing a multi-centre open-label single-dose substitution study to assess the acceptability of 3D-printed medications among patients and develop a grant application for further research phases. Timelines for Delivery The project is planned over three years: Year 1: WP1+2 will be executed to identify needs and evaluate current dosing methods. Year 2: WP3 will focus on validating 3D printing processes and cost analysis. Year 3: WP4 will involve a multi-centre study to assess patient acceptability and develop a comprehensive grant proposal for future research. Regular meetings with the supervisory team, collaborators, and patient involvement panels will ensure the project's timely progression and address emerging challenges. Anticipated Impact and Dissemination This research will answer if 3D-printed personalised formulations are acceptable to children and feasible to implement in hospitals. It will pave the way towards the administration of a 3D-printed personalised medicine in children in the UK. The study outputs will include validated formulation methods for point-of-care 3D printing and cost comparisons. The findings will be disseminated through: - Peer-reviewed journal publications - Presentations at conferences - Development of informational materials with patient representatives Additionally, collaboration with international centres will bring knowledge and expertise to NHS and UK. Successful implementation could revolutionize paediatric oncology treatments, offering significant health and economic benefits on a global scale. The study also aims to pave the way for regulatory approval of 3D-printed formulations, potentially leading to widespread adoption within the next 5 to 10 years.