3D PRINTING OF PERSONALIZED ORAL SOLID DOSAGE FORMS: FORMULATION STRATEGIES, CLINICAL DRIVERS, AND TRANSLATIONAL CHALLENGES

Abstract

Background: Over the past decade, additive manufacturing has enabled on-demand fabrication of patient-specific oral solid dosage forms in which dose, geometry and internal architecture are programmed from a digital design—capabilities conventional batch tableting cannot readily deliver.

Scope & Approach: This review critically examines formulation strategies underlying the development of 3D-printed personalized OSDs, with emphasis on material selection, printability, drug–polymer interactions and the impact of processing parameters on critical quality attributes, including content uniformity, mechanical integrity, and drug release performance.

Clinical Drivers: Clinical needs for personalization—such as pediatric and geriatric dosing, narrow therapeutic index drugs and scenarios requiring patient-specific release profiles—are summarized to highlight unmet therapeutic needs.

Key Findings: Advances in fused deposition modeling, semi-solid extrusion, binder jetting and inkjet printing are evaluated in the context of formulation flexibility and translational feasibility.

Conclusions: Despite substantial progress, clinical implementation remains constrained by regulatory uncertainty, scalability–personalization trade-offs, quality assurance requirements and stability considerations. Future opportunities integrating QbD, PAT and digital design tools are discussed as enablers for robust, regulatory-compliant translation of personalized 3D-printed OSDs into clinical practice.