Developing a Robust In Vitro Release Method for a Polymeric Nanoparticle: Challenges and Learnings

Nanomedicines have been highlighted as a promising approach for targeted drug delivery, as they can improve drug efficacy and reduce systemic toxicity. Due to the wide range of formulation types and the complex nature of the drug release mechanism, the development of an in vitro release (IVR) method for nanomedicines is challenging and regulatory guidance is limited. In this work, we are outlining the IVR method development for a controlled-release polymeric nanoparticle. This included the optimisation of the release medium composition and the selection of an appropriate sampling technique for the isolation of the released drug from the formulation. In addition to the established ultracentrifugation, the NanoDis showed potential as an automated technique.