Department of Pharmaceutical Sciences, College of Pharmacy, Gulf Medical University, P.O. Box 4184, Ajman, United Arab Emirates.
Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, 31982, Saudi Arabia.
AAPS PharmSciTech. 2020 Aug 3;21(6):220. doi: 10.1208/s12249-020-01771-4.
The 3D printing is considered as an emerging digitized technology that could act as a key driving factor for the future advancement and precise manufacturing of personalized dosage forms, regenerative medicine, prosthesis and implantable medical devices. Tailoring the size, shape and drug release profile from various drug delivery systems can be beneficial for special populations such as paediatrics, pregnant women and geriatrics with unique or changing medical needs. This review summarizes various types of 3D printing technologies with advantages and limitations particularly in the area of pharmaceutical research. The applications of 3D printing in tablets, films, liquids, gastroretentive, colon, transdermal and intrauterine drug delivery systems as well as medical devices have been briefed. Due to the novelty and distinct features, 3D printing has the inherent capacity to solve many formulation and drug delivery challenges, which are frequently associated with poorly aqueous soluble drugs. Recent approval of Spritam® and publication of USFDA technical guidance on additive manufacturing related to medical devices has led to an extensive research in various field of drug delivery systems and bioengineering. The 3D printing technology could be successfully implemented from pre-clinical phase to first-in-human trials as well as on-site production of customized formulation at the point of care having excellent dose flexibility. Advent of innovative 3D printing machineries with built-in flexibility and quality with the introduction of new regulatory guidelines would rapidly integrate and revolutionize conventional pharmaceutical manufacturing sector.
3D 打印被认为是一种新兴的数字化技术，可以成为未来个性化剂型、再生医学、假体和可植入医疗器械精确制造的关键推动因素。从各种药物输送系统定制尺寸、形状和药物释放曲线，可以使儿科、孕妇和老年人等特殊人群受益，这些人群具有独特或不断变化的医疗需求。本综述总结了各种类型的 3D 打印技术的优缺点，特别是在制药研究领域。简述了 3D 打印在片剂、薄膜、液体、胃滞留、结肠、透皮和宫内药物输送系统以及医疗器械中的应用。由于其新颖性和独特的特点，3D 打印具有内在的能力来解决许多与水溶解度差的药物相关的配方和药物输送挑战。Spritam®的最近批准和美国 FDA 关于医疗器械的增材制造技术指南的发布，导致了在药物输送系统和生物工程的各个领域广泛的研究。3D 打印技术可以成功地从临床前阶段应用到首次人体试验，以及在护理点现场生产定制配方，具有极好的剂量灵活性。具有内置灵活性和质量的创新 3D 打印机械的出现，以及新监管指南的引入，将迅速整合并彻底改变传统制药行业。
