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引用次数: 0
摘要
背景/目标:在病人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化。Spritam®(左乙拉西坦)是首个三维打印药物,它获得美国食品及药物管理局(FDA)批准后,引发了人们对将熔融沉积建模(FDM)三维打印应用于制药,特别是生产多肽类药物的兴趣:本综述概述了 FDM 三维打印在药物剂型开发中的应用,重点介绍了其操作、打印参数、材料、添加剂、优势和局限性。还讨论了一些关键问题,如个性化用药的能力以及与该技术相关的挑战,包括药物在高温下的稳定性:结果:从最初的 60 项研究中分析了 14 项与 FDM 3D 打印多丸相关的研究。发表论文的数量不断增加,表明全球对这项技术的兴趣日益浓厚,其中英国的研究数量最多:结论:FDM 三维打印技术能够精确控制剂型,并根据患者的不同需求进行定制治疗,为个性化医疗提供了巨大潜力。然而,要充分发挥 FDM 3D 打印技术在医药制造领域的潜力,还必须解决打印温度过高和大规模生产缺乏标准化 GMP 指南等限制因素。
Fabrication of Polypill Pharmaceutical Dosage Forms Using Fused Deposition Modeling 3D Printing: A Systematic Review.
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.
Methods: 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.
Results: 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.
Conclusions: 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.
PharmaceuticsPharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
7.90
自引率
11.10%
发文量
2379
审稿时长
16.41 days
期刊介绍:
Pharmaceutics (ISSN 1999-4923) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers, communications, and short notes. Covered topics include pharmacokinetics, toxicokinetics, pharmacodynamics, pharmacogenetics and pharmacogenomics, and pharmaceutical formulation. Our aim is to encourage scientists to publish their experimental and theoretical details in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.