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Pharmaceutical 3D Printing Systems: Design Logic, Manufacturing Constraints, and Regulatory Readiness
Pharmaceutical 3D printing has emerged as a technically powerful approach for producing personalised, flexible, and on-demand dosage forms. Its appeal lies in the ability to vary dose, geometry, release profile, and patient acceptability without requiring a new conventional manufacturing line for every product variant. Despite this promise, the field remains constrained by a persistent mismatch between design capability and translational readiness. Many studies demonstrate sophisticated printed tablets, films, lattices, and personalised dosage forms, yet far fewer address the manufacturing controls, release strategies, and regulatory evidence needed for routine clinical implementation. This critical review evaluates pharmaceutical 3D printing through the connected lenses of design logic, manufacturing constraints, and regulatory readiness. The review treats additive manufacturing not as one technology but as a family of processes whose material requirements, process risks, and quality attributes differ substantially. The review concludes that pharmaceutical 3D printing will not translate through formulation novelty alone. A technology-agnostic, risk-proportionate regulatory pathway combined with scalable, PAT-integrated manufacturing platforms is essential to move from promise to practice.
EAMD 3
Original Research | Open access | 10 January 2025 | Article: 171

Selecting Lipid Nanoparticles, Polymeric Carriers, Implants, and 3D-Printed Dosage Platforms for Advanced Drug Delivery
Advanced drug delivery now includes lipid nanoparticles, polymeric carriers, implants, and 3D-printed dosage forms, each offering distinct advantages for controlling where, when, and how drugs are released. These platforms differ in their suitability for nucleic acids, small molecules, biologics, local therapy, systemic exposure, long-acting treatment, and personalised dosing. The breadth of available options has expanded faster than the decision tools used to choose among them. Platform selection is often driven by familiarity, institutional capability, technological enthusiasm, or precedent within a therapeutic area. Such heuristic decisions can produce poor alignment between the drug, the target product profile, the patient population, and the manufacturing pathway. A structured framework is therefore needed to make platform choice more transparent, reproducible, and development-relevant. This article constructs an original decision framework for selecting among lipid nanoparticles, polymeric carriers, implants, and 3D-printed dosage platforms. The framework treats platform choice as a multi-criteria decision problem rather than as a single-attribute optimisation exercise. It integrates drug properties, release requirements, stability, scalability, usability, regulatory precedent, and cost into a practical selection process. A criteria-driven platform selection process can help development teams avoid technology-led formulation choices and instead align delivery strategy with therapeutic purpose. The proposed framework is intended to support early-stage screening, translational planning, quality-by-design discussions, and portfolio decisions. Its central argument is that no advanced delivery platform is inherently superior; the best platform is the one that best satisfies the target product profile under real development constraints.
EAMD 3
Original Research | Open access | 10 July 2025 | Article: 185