Yasin Haya, Al-Tabakha Moawia M A, Chan Siok Yee
School of Pharmaceutical Sciences, Universiti Sains Malaysia, Gelugor 11800, Pulau Pinang, Malaysia.
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman P.O. Box 346, United Arab Emirates.
Pharmaceutics. 2024 Sep 30;16(10):1285. doi: 10.3390/pharmaceutics16101285.
BACKGROUND/OBJECTIVES: The pharmacy profession has undergone significant changes driven by advancements in patient care and healthcare systems. The FDA approval of Spritam (levetiracetam), the first 3D-printed drug, has sparked increased interest in the use of Fused Deposition Modeling (FDM) 3D printing for pharmaceutical applications, particularly in the production of polypills.
This review provides an overview of FDM 3D printing in the development of pharmaceutical dosage forms, focusing on its operation, printing parameters, materials, additives, advantages, and limitations. Key aspects, such as the ability to personalize medication and the challenges associated with the technique, including drug stability at high temperatures, are discussed.
Fourteen studies relevant to FDM 3D-printed polypills were analyzed from an initial pool of 60. The increasing number of publications highlights the growing global interest in this technology, with the UK contributing the highest number of studies.
FDM 3D printing offers significant potential for personalized medicine by enabling precise control over dosage forms and tailoring treatments to individual patient needs. However, limitations such as high printing temperatures and the lack of standardized GMP guidelines for large-scale production must be addressed to fully realize its potential in pharmaceutical manufacturing.
背景/目的：在患者护理和医疗保健系统进步的推动下，药学专业发生了重大变革。首款3D打印药物斯普瑞坦（左乙拉西坦）获得美国食品药品监督管理局（FDA）批准，引发了人们对熔融沉积建模（FDM）3D打印在制药应用中使用的兴趣增加，尤其是在多片制剂的生产方面。
本综述概述了FDM 3D打印在药物剂型开发中的应用，重点介绍其操作、打印参数、材料、添加剂、优点和局限性。讨论了关键方面，如个性化给药的能力以及与该技术相关的挑战，包括高温下的药物稳定性。
从最初的60项研究中分析了14项与FDM 3D打印多片制剂相关的研究。出版物数量的增加凸显了全球对该技术兴趣的增长，其中英国的研究数量最多。
FDM 3D打印通过能够精确控制剂型并根据个体患者需求定制治疗方案，为个性化医疗提供了巨大潜力。然而，要充分实现其在制药制造中的潜力，必须解决诸如打印温度高和缺乏大规模生产的标准化GMP指南等限制。
