Rapid, green and self-optimised additive manufacturing of medicines

点击翻译按钮获取中文摘要

The development of oral solid dose (OSD) products using traditional approaches takes several years. This development process is not only laborious and time consuming but also environmentally unfriendly: valuable solvents, materials and energy are consumed during extensive empirically driven product development trials. There is also a significant lack of responsiveness and fragility of medicine supply chain was exposed and magnified by the COVID-19 pandemic, impacting both the supply chains of excipients and drugs. This project aims to develop a fundamental new approach to medicines manufacture by combing additive manufacturing (AM) with self-optimisation methods to make a significant contribution towards realising a rapid, responsive, green formulation and production platform for future medicines.AM (e.g. 3D printing) is showing considerable promise as a production platform for medicines, in particular for low-volume, high-value products. AM is also uniquely placed to enable rapid modification of dose and drug release behaviour to meet specific patient requirements. In this project, both dose and drug release will be adjusted through the optimisation of the size, microstructure and process settings. A self-optimisation method will be developed to accelerate experimental design and system optimisation. Similar methods have been used for experimental design in pharmaceutical tablet development to optimise formulation and process parameters, demonstrating a reduction of experimental workload of 60% compared to a traditional design of experiments approach. Coupling AM with self-optimisation, as proposed in the project, will allow us to realise a rapid, green and responsive manufacturing platform. This new platform will also enable the efficient exploration of the material - process - structure - performance relationship, leading to a step change in our understanding in the digital design of pharmaceutical products using AM.The proposed project will contribute to a digital product designer with the goal of enabling a 'right first time' manufacturing of high quality and stable products. Digital tools in drug product manufacturing will also have a drastic positive environmental impact by reducing the waste of raw materials, energy consumption and the use of solvents in dissolution testing.