Development and validation of a production and a dosage methods of 3D printed tablets containing prednisolone

Interest for 3D printers in hospital pharmacies has grown significantly in recent years. This technology offers an interesting alternative for oral suspensions and capsules as part of personalized medicine. The production unit of the Lausanne university hospital pharmacy has purchased a 3D printer (CurifyLabs) to provide the pediatric units with a new galenic form. 3D printed tablets of prednisolone has been developed for the pediatric oncology unit. For long-term treatment, these tablets are easy to use, have favorable storage conditions and allow us to hide the bad taste that is often described with this molecule. Three batches of 25 tablets were produced with a formulation of prednisolone 1%. Two different doses, 2mg and 5mg, were tested (of 200mg and 500mg unit mass). We tested two production protocols: a manual one and an automated one; for the analytical part, we developed a dosage method using HPLC-UV in accordance with ICH Q2(R2) standards.
As a result, mass and content uniformity tests show us that the production protocol of 3D printed tablets is similar to the production of capsules and that the automated process is faster than the manual process by reducing production steps. It eliminates human-induced variation during the critical step of mixing raw materials.
In conclusion, the manual process is deemed more efficient than the manual process and has fewer critical steps. Based on these encouraging results, we plan to test these 3D printed tablets in patients to assess their tolerability and acceptability. Other active ingredients are in the pipeline to expand our options for care units.