AI Applied to Formulation Design, Process Optimization, and Quality Control in 3D Printed Drug Products: Protocol for a Scoping Review

Abstract

Background 3D printing is an advanced, computer-aided design (CAD)–guided, layer-by-layer manufacturing technology with strong potential for producing patient-specific drug products. Integrating AI with pharmaceutical 3D printing can accelerate formulation development, improve process robustness and quality, and enable efficient personalization across the preprinting, printing, and postprinting stages. However, evidence remains dispersed across technologies, dosage forms, and AI approaches, making it difficult to obtain a comprehensive understanding of current research and knowledge gaps. Objective This scoping review protocol aims to map and characterize how AI has been applied to the formulation design, process optimization, and quality control of 3D printed drug products across the preprinting, printing, and postprinting stages. Methods This review will follow the Joanna Briggs Institute (JBI) methodology and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist and guidelines for scoping reviews. The following databases and resources will be searched: MEDLINE (PubMed), Scopus, and Web of Science. Screening, data extraction, and data analysis will be conducted by 2 reviewers independently. Findings will be presented in summary tables and a narrative synthesis. Results The protocol and search strategy were finalized in April 2026, and the review was registered on the Open Science Framework (OSF). Literature searches are scheduled to be conducted between May 2026 and June 2026, followed by title and abstract screening and full-text assessment between June 2026 and August 2026. Data extraction and narrative synthesis are expected to be completed by September 2026. The final scoping review is expected to be submitted for publication in the fourth quarter of 2026. Conclusions This protocol outlines a scoping review to map the use of AI in the formulation design, process optimization, and quality control of 3D printed drug products, and summarize current research and identify areas for future investigation. Trial Registration Open Science Framework 10.17605/OSF.IO/2R8ED; https://osf.io/2r8ed/overview International Registered Report Identifier (IRRID) PRR1-10.2196/98251