熔融沉积成型3D打印法莫替丁口服脉冲制剂的研究（英文）

为了制备具有不同药物延迟释放时间,按照患者需求实现个性化给药的脉冲制剂,本研究将熔融沉积成型(fuseddepositionmodeling,FDM)3D打印技术引入制剂领域,探讨了以该技术结合传统工艺制备核壳型口服脉冲制剂的可行性。该制剂的“核”是以传统工艺制备的市售片剂,而不含药物的外层壳是以FDM 3D打印技术制备的。本研究采用不同参数设计了三种外壳的片剂,并对其形态、尺寸、片重、硬度和体外释药进行了表征和评价。结果表明3D打印片剂外型完好,无缺陷。脉冲片剂的大小、片重、硬度及体外释药行为均与外壳参数相关,通过调节外壳参数可以实现药物个性化的体外5–7小时的延迟释放。本研究探索了制备脉冲制剂的新方法和实现脉冲制剂个性化给药的新途径。

Fused deposition modeling 3D printed oral famotidine pulsatile release tablets

The aim of this study was to prepare pulsatile release tablets which provide different drug delayed-release time and realize personalized administration according to the needs of patients. Fused deposition modeling (FDM) 3D printing technology was introduced into the field of pharmaceutics in this study, and the feasibility to prepare core-shell pulsatile release tablets was explored by combing 3D printing technology with the traditional manufacturing technology. The core of the pulsatile tablets was a commercial tablet obtained from the traditional technology, and the drug-free shell was prepared by the FDM 3D printing technology. Three kinds of tablet shells were designed using different parameters. Furthermore, the morphology, size, weight, hardness, and in vitro drug release of the 3D printed famotidine pusatile tablets were characterized and evaluated. The results showed that the 3D printed tablets appeared intact without any defects. Different parameters of outer shell affected the size, weight, hardness, and in vitro drug release of the tablets. The tablets achieved a personalized delayed release time varying from 5 to 7 h in vitro. In this way, a new method for preparing pulsatile release tablets and a new way for the personalized administration of pulsatile tablets were explored in this study.