Moreira Amanda de O E, Neta Lêda Maria S Azevedo, Pietroluongo Márcia, Matos Ana Paula Dos S, Correa Beatriz B, Ortiz Beatriz H, Guimarães André da S, Nele Marcio, Santos Carollyne M, Fai Ana Elizabeth C, Gonçalves Maria Helena, Shimizu Flávio M, Dos Santos Monique S, Moure Rosemberg B, Nascimento Diogo D, Guimarães André Luis de A, Junior Saint Clair Dos S G, Vicosa Alessandra L, Cabral Lucio M
Laboratory of Pharmaceutical Industrial Technology (LabTIF), Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro 21941-902, Brazil.
Laboratory of Experimental Pharmacotechnics, Department of Galenic Innovation, Oswaldo Cruz Foundation (FIOCRUZ), Farmanguinhos, Rio de Janeiro 22775-903, Brazil.
Pharmaceutics. 2025 May 17;17(5):658. doi: 10.3390/pharmaceutics17050658.
: 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. : 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. : 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. : This innovative approach offers a promising solution for pediatric LTBI treatment, as it improves efficacy, medication acceptability, and on-demand access.
儿童给药因吞咽传统药物困难以及许多药物味道不佳而受到阻碍。在凸显改进儿童给药需求的疾病中，结核病（TB）尤为突出。该疾病的一种形式是潜伏性结核感染（LTBI），这在儿童中令人担忧。有效的LTBI治疗对预防至关重要，异烟肼（INH）因其已证实的疗效和安全性而被广泛使用。本研究旨在开发用于LTBI治疗的含INH的创新3D打印可咀嚼凝胶。
这些凝胶使用明胶、角叉菜胶、无糖甜味剂和调味剂配制而成。制备了两批，并使用带有半固体挤出（SSE）模块的3D打印（3DP）生产出可咀嚼凝胶。测量流变学性质以评估3DP-SSE的可行性，评估制剂的结构完整性和适当的流动性。通过外观、质量和尺寸特征对3D打印的可咀嚼凝胶进行评估。此外，还研究了水分活度、质地剖面、INH和降解产物含量、体外释放和掩味情况。
优化后的制剂保持了适合3DP-SSE的流变学性质，在该过程后显示出一致的重量、尺寸和稳定性。质地在打印参数和形状保持之间达到了平衡，并且INH呈现速释特征（30分钟内>85%）。与传统的INH片剂相比，可咀嚼凝胶的适口性有所改善。
这种创新方法为儿童LTBI治疗提供了一个有前景的解决方案，因为它提高了疗效、药物可接受性和按需获取性。
