Published Paper Details:

BCS Class III drugs -- characterized by high aqueous solubility and low membrane permeability -- present a paradox for formulators: dissolution is usually straightforward but moisture affinity and microenvironmental chemistry frequently shorten shelf life. This review focuses on the challenges encountered when deploying strategies intended to increase shelf life and stability for Class III APIs. We examine the physical and chemical mechanisms that drive instability, survey the spectrum of modern stabilization technologies (co-crystals, salts/co-formers, solid dispersions, hot-melt extrusion (HME), micro/nanoencapsulation, ionic liquids, smart packaging), and then emphasize the translational barriers: excipient interactions, processing moisture/thermal stress, analytical and predictive limitations, regulatory complexity, and cost/scale hurdles. The goal is to provide a realistic, evidence based guide that helps researchers and industry teams choose and de-risk stability strategies for Class III compounds.