Unlocking Nano-Drug Potential: Revolutionizing In Vitro Dissolution Testing for Nanomedicines

In-vitro dissolution study is crucial for quality assurance and stability, serving as a surrogate test for evaluating in-vivo performance of a drug. The dissolution procedure should be designed using an appropriate validated approach, depending on the type of dosage form. Dissolution testing is crucial to regulatory decision-making in a number of aspects. Conventional formulations have validated regulatory-compliant dissolution methods, conversely novel drug formulations like nanoparticles and microparticles lack standard validated procedures for the same. The present article provides information about the various compendial and non-compendial methods available for in-vitro dissolution testing of nano-formulations including the selection of dissolution media, different factors affecting the release, advancements in the dissolution procedures and also included the recently developed marketed nano-formulations.