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将3D打印与热熔挤出相结合以生产控释片剂。

Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets.

作者信息

Zhang Jiaxiang, Feng Xin, Patil Hemlata, Tiwari Roshan V, Repka Michael A

机构信息

Department of Pharmaceutics and Drug Delivery, The University of Mississippi, MS, 38677, United States.

Department of Pharmaceutics and Drug Delivery, The University of Mississippi, MS, 38677, United States; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS, 38677, United States.

出版信息

Int J Pharm. 2017 Mar 15;519(1-2):186-197. doi: 10.1016/j.ijpharm.2016.12.049. Epub 2016 Dec 23.

DOI:10.1016/j.ijpharm.2016.12.049
PMID:28017768
Abstract

The main objective of this work was to explore the potential of coupling fused deposition modeling in three-dimensional (3D) printing with hot-melt extrusion (HME) technology to facilitate additive manufacturing, in order to fabricate tablets with enhanced extended release properties. Acetaminophen was used as the model drug and different grades and ratios of polymers were used to formulate tablets. Three-point bending and hardness tests were performed to determine the mechanical properties of the filaments and tablets. 3D-printed tablets, directly compressed mill-extruded tablets, and tablets prepared from a physical mixture were evaluated for drug release rates using a USP-II dissolution apparatus. The surface and cross-sectional morphology of the 3D-printed tablets were assessed by scanning electron microscopy. Differential scanning calorimetry and thermogravimetric analysis were used to characterize the crystal states and thermal properties of materials, respectively. The 3D-printed tablets had smooth surfaces and tight structures; therefore, they showed better extended drug release rates than the directly compressed tablets did. Further, this study clearly demonstrated the feasibility of coupling HME with 3D printing technology, which allows for the formulation of drug delivery systems using different grades and ratios of pharmaceutical polymers. In addition, formulations can be made based on the personal needs of patients.

摘要

这项工作的主要目的是探索将三维(3D)打印中的熔融沉积建模与热熔挤出(HME)技术相结合以促进增材制造的潜力,从而制造出具有增强缓释性能的片剂。对乙酰氨基酚用作模型药物,并使用不同等级和比例的聚合物来制备片剂。进行三点弯曲和硬度测试以确定长丝和片剂的机械性能。使用USP-II溶出装置评估3D打印片剂、直接压片的研磨挤出片剂以及由物理混合物制备的片剂的药物释放速率。通过扫描电子显微镜评估3D打印片剂的表面和横截面形态。差示扫描量热法和热重分析分别用于表征材料的晶态和热性能。3D打印片剂表面光滑且结构紧密;因此,它们显示出比直接压片更好的药物缓释速率。此外,本研究清楚地证明了将HME与3D打印技术相结合的可行性,这使得可以使用不同等级和比例的药用聚合物来制备药物递送系统。此外,可以根据患者的个人需求进行制剂制备。

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