Background/Objectives: Pediatric drug administration is hindered by difficulties in swallowing conventional medications and the unpalatable taste of many drugs. Among diseases highlighting the need for improved pediatric delivery, tuberculosis (TB) stands out. One form of the disease is latent TB infection (LTBI), which is concerning in children. Effective LTBI treatment is crucial for prevention, with isoniazid (INH) widely used for its proven efficacy and safety. This study aims to develop innovative 3D-printed chewable gels containing INH for LTBI treatment. Methods: The gels were formulated using gelatin and carrageenan gum, sugar-free sweeteners, and flavoring. Two batches were prepared, and using 3D printing (3DP) with a semi-solid extrusion (SSE) module, chewable gels were produced. Rheological properties were measured to assess the feasibility of 3DP-SSE, evaluating the structural integrity and adequate fluidity of the formulation. The 3D-printed chewable gels were evaluated by visual, mass, and dimensional characteristics. In addition, the water activity, texture profile, INH and degradation product content, in vitro release, and taste-masking were investigated. Results: The optimized formulation maintained suitable rheological properties for 3DP-SSE, demonstrating consistent weight, dimensions, and stability after the process. The texture achieved a balance between printing parameters and shape maintenance, and the INH presented an immediate-release profile (>85% within 30 min). The chewable gels showed an improvement in palatability compared to conventional INH tablets. Conclusions: This innovative approach offers a promising solution for pediatric LTBI treatment, as it improves efficacy, medication acceptability, and on-demand access.

Introduction: The application of three-dimensional printing technology (3DP) has gained notoriety as an alternative to the traditional manufacturing model in the production of medicines, enabling the development of personalized medicines for each patient. Objective: To consolidate the currently available information regarding the regulatory perspectives on the use of 3DP in pharmaceutical manufacturing and to discuss the challenges that must be addressed to enable its broad adoption. Method: This work consists of an integrative literature review in the National Library of Medicine (PubMed) and Web of Science covering the period from December 2019 to December 2024, which approaches the regulatory basis that guide the application of 3DP in the medicine production, in comparison with the traditional production methods, and what are the main gaps and challenges associated with these regulations. Results: The evaluated articles highlight the need of establishing specific regulations focused on the quality and manufacturing sites of medications produced by 3DP, to enable their adoption as an option for supplying personalized medicines. The results reported in this review show that the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines & Healthcare products Regulatory Agency (MHRA) have adopted monitoring of new technologies and advising institutions as a way of enabling the introduction of these medicines in the market and prepare new regulations. Conclusions: The information in this article serves as a preliminary basis to understand the existing regulatory challenges in relation to 3DP of medicines and provide a vision of the scenarios that are being proposed for this technology insertion.