Karalia Danae, Siamidi Angeliki, Karalis Vangelis, Vlachou Marilena
Section of Pharmaceutical Technology, Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece.
Pharmaceutics. 2021 Sep 3;13(9):1401. doi: 10.3390/pharmaceutics13091401.
The aim of this review is to present the factors influencing the mechanical properties of 3D-printed oral dosage forms. It also explores how it is possible to use specific excipients and printing parameters to maintain the structural integrity of printed drug products while meeting the needs of patients. Three-dimensional (3D) printing is an emerging manufacturing technology that is gaining acceptance in the pharmaceutical industry to overcome traditional mass production and move toward personalized pharmacotherapy. After continuous research over the last thirty years, 3D printing now offers numerous opportunities to personalize oral dosage forms in terms of size, shape, release profile, or dose modification. However, there is still a long way to go before 3D printing is integrated into clinical practice. 3D printing techniques follow a different process than traditional oral dosage from manufacturing methods. Currently, there are no specific guidelines for the hardness and friability of 3D printed solid oral dosage forms. Therefore, new regulatory frameworks for 3D-printed oral dosage forms should be established to ensure that they meet all appropriate quality standards. The evaluation of mechanical properties of solid dosage forms is an integral part of quality control, as tablets must withstand mechanical stresses during manufacturing processes, transportation, and drug distribution as well as rough handling by the end user. Until now, this has been achieved through extensive pre- and post-processing testing, which is often time-consuming. However, computational methods combined with 3D printing technology can open up a new avenue for the design and construction of 3D tablets, enabling the fabrication of structures with complex microstructures and desired mechanical properties. In this context, the emerging role of computational methods and artificial intelligence techniques is highlighted.
本综述的目的是介绍影响3D打印口服剂型机械性能的因素。它还探讨了如何利用特定的辅料和打印参数来维持打印药品的结构完整性，同时满足患者的需求。三维（3D）打印是一种新兴的制造技术，在制药行业正逐渐得到认可，以克服传统的大规模生产，并朝着个性化药物治疗发展。经过过去三十年的持续研究，3D打印现在在口服剂型的尺寸、形状、释放曲线或剂量调整方面提供了众多个性化的机会。然而，在3D打印融入临床实践之前，仍有很长的路要走。3D打印技术遵循与传统口服剂型制造方法不同的流程。目前，对于3D打印固体口服剂型的硬度和脆碎度没有具体的指导原则。因此，应建立3D打印口服剂型的新监管框架，以确保它们符合所有适当的质量标准。固体剂型机械性能的评估是质量控制的一个组成部分，因为片剂在制造过程、运输和药品分发过程中以及终端用户的粗暴处理过程中必须承受机械应力。到目前为止，这是通过广泛的预处理和后处理测试来实现的，这通常很耗时。然而，计算方法与3D打印技术相结合可以为3D片剂的设计和构建开辟一条新途径，能够制造具有复杂微观结构和所需机械性能的结构。在这种背景下，计算方法和人工智能技术的新兴作用得到了突出体现。
