Evaluation of NanoDis as an Automated Sampling Technology for In Vitro Release Testing of Nanomedicines

Nanoparticles can be used in pharmaceuticals to provide a targeted and prolonged release of active pharmaceutical ingredient (API). Nanoparticles are growing in application in the field of oncology due to developments in the field, but still there are issues faced with studying the in vitro release of long-acting injectables. A method using the sample and separate approach via ultracentrifugation was used for a polymeric nanoparticle product with an in vitro release over 10 days. This method is laborious, with many areas of manual intervention, which reduces robustness and provides limited temporal resolution of the in vitro release profile due to sampling timepoints. NanoDis is a recently developed automated sampling system that uses tangential flow filtration (TFF) to separate released and encapsulated API over the in vitro release profile, with minimal analyst input and enhanced temporal resolution compared to other methods. This article highlights the success of implementing NanoDis for automated sampling of polymeric nanoparticles, with release profiles comparable to the ultracentrifugation method, showing potential for a more robust and quality control friendly method.