Integrating Modified-Release Systems with Personalized Medicine: A Salient Framework for Disease Management

Modified-release (MR) drug delivery systems offer precise spatiotemporal control of drug exposure, allowing for alignment with interindividual pharmacokinetic (PK) and pharmacodynamic (PD) variability, and addressing the fundamental shortcomings of conventional fixed-dose therapies in chronic disease management. This narrative review critically examines recent advances in MR platforms, including stimuli-responsive systems and advanced nanocarriers that enable patient-centric customization based on age, physiological status, genetic variability, and comorbidity profiles. The integration of MR formulation design with quantitative clinical pharmacology tools, such as model-informed precision dosing (MIPD), physiologically based pharmacokinetic (PBPK) modeling, and in vitro–in vivo correlation (IVIVC), is highlighted as a key strategy for enhancing translational predictability, optimizing therapeutic performance, and facilitating regulatory acceptance. Emerging manufacturing technologies, particularly three-dimensional (3D) printing, are discussed as disruptive enablers of on-demand, patient-specific MR dosage forms, with growing evidence of clinical and operational feasibility in pediatric populations and complex treatment regimens. Furthermore, the convergence of digital patient twins (DPTs), real-time clinical data streams, and adaptive analytics is positioned as a transformative paradigm for dynamically optimized therapies. Collectively, these developments establish an integrated framework for MR-enabled personalized medicine, supporting the rational design and scalable implementation of individualized therapeutic strategies for chronic diseases requiring long-term pharmacological intervention.