2D- and 3D printed drugs

Abstract

Until now, medicinal products and clinical trial samples have been made available at great expense either by the pharmaceutical industry or by appropriately qualified clinical pharmacies. From a legal point of view, it is relevant that a system consisting of hardware (GMP-compliant printers and in-process controls) as well as software and inks containing active ingredients (2D printing) or polymers (3D printing) is developed and made available. This system must be coordinated and validated. Through the technology of GMP-compliant 2D and 3D printing, it is now possible to produce clinical trial samples including the production of corresponding placebos. The advantage of digital printing of medicinal products and clinical trial samples lies above all in the dosage, which can be flexibly changed at any time, the rapid production on site and the flexible combination of active ingredients in a printed tablet. This means that in clinical trials, such as targeted drug repurposing, or in everyday clinical practice, the drug can now be produced in exactly the dose that is really needed individually. In addition, drugs can be individually printed in a tablet so that each patient receives the tablet in the appropriate dose that he or she really needs. Furthermore, only what is actually used is produced, and the creation of unnecessary pharmaceutical waste is prevented. The process is resource-saving. The aim is that this technology, developed in Europe on the REPO4EU platform, will be able to demonstrate its advantages for the production of clinical trial samples and will be used routinely.