Personalized Drug Delivery Systems

Abstract

Personalized drug delivery systems adapt their behaviour to the individual patient -- in dose, in release timing, in delivery site, or in responsiveness to patient-specific physiological signals -- in ways that conventional one-size-fits-all formulations cannot. The clinical case for personalization is strongest in indications where patient-specific factors drive substantial pharmacokinetic or pharmacodynamic variability: paediatric dosing where body weight and organ maturity vary across orders of magnitude, oncology where tumour biology and renal function shift therapeutic windows patient by patient, chronic disease management where disease activity fluctuates over months and years, and rare diseases where the small patient populations amplify the cost of treatment failures from inadequate dose individualisation. This study presents the Personalized Drug Delivery System Assessment Framework (PDDSAF), evaluating five personalization approaches -- 3D-printed patient-specific dosage forms (3DP-DF), pharmacogenomically-guided dosing platforms (PGx-DP), closed-loop physiologically-responsive delivery systems (CL-PRD), AI-personalised infusion and pump therapy (AI-IPT), and patient-derived biologic personalization for cell and gene therapies (PD-BP) -- across four clinical contexts: paediatric dosing, oncology treatment, chronic autoimmune disease, and rare genetic disease. Performance was scored using the Personalization Effectiveness Score (PES), a weighted composite of clinical outcome improvement (0.30), dose or regimen individualisation precision (0.20), implementation feasibility (0.20), manufacturing or deployment scalability (0.15), and regulatory acceptance (0.15). Closed-loop physiologically-responsive delivery achieved the highest PES (0.892) through the best clinical outcome improvement (0.940) and individualisation precision (0.940). AI-personalised infusion therapy ranked second (0.879) with the best implementation feasibility (0.920) and scalability (0.900). Pharmacogenomic-guided dosing (0.871) showed strong regulatory acceptance. 3D-printed patient-specific dosage forms (0.854) offer unique capability for paediatric and rare disease contexts. Patient-derived biologic personalization (0.832) delivers transformative clinical outcomes in cell therapy but faces substantial manufacturing scalability constraints.