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使用基于粉末的3D打印技术制备无崩解剂的口腔崩解片。

Fabricating Oral Disintegrating Tablets Without Disintegrant Using Powder-Based 3D Printing.

作者信息

Wang Jiu, Liu Shunfang, Lin Minmei, Chen Peihong, Yi Huagui, Lv Zhufen, Liu Yuanfen

机构信息

Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China.

Guangdong High Education Institutes Engineering Research Center of Modified-Released Pharmaceutical Products, School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou 510006, China.

出版信息

Pharmaceutics. 2025 Mar 28;17(4):435. doi: 10.3390/pharmaceutics17040435.

DOI:10.3390/pharmaceutics17040435
PMID:40284430
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12030749/
Abstract

: Powder-based 3D printing, an advanced additive manufacturing technique, can produce oral disintegrating tablets (ODTs) without disintegrants, creating larger-pored tablets via layer-by-layer powder stacking for better water absorption than traditional tablets. : This study focused on using powder-based 3D printing to fabricate clozapine-based ODTs. Through central composite design (CCD), the formulation of ODTs was optimized for rapid disintegration. Analytical techniques such as X-ray Powder Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and Differential Scanning Calorimetry (DSC) were employed to investigate the compatibility between clozapine and excipients. : The optimized 3D-printed ODTs exhibited a remarkably short disintegration time of (9.9 ± 0.7) s compared to (40) s for compressed tablets. The contact angle of the 3D-printed ODTs was measured as 60.48 ± 0.36°, indicating favorable wettability for disintegration. Scanning Electron Microscopy (SEM) analysis revealed a porous structure in 3D-printed tablets, with a porosity of 48.97% (over two times higher than that of compressed tablets as determined by mercury injection meter). : Collectively, this finding demonstrates the feasibility of fabricating highly hydrophilic and non-distensible ODTs without disintegrants using powder-based 3D printing.

摘要

基于粉末的3D打印是一种先进的增材制造技术，可生产无需崩解剂的口腔崩解片（ODT），通过逐层粉末堆积制造出具有更大孔隙的片剂，比传统片剂具有更好的吸水性。：本研究聚焦于使用基于粉末的3D打印来制造基于氯氮平的ODT。通过中心复合设计（CCD），对ODT的配方进行了优化以实现快速崩解。采用了诸如X射线粉末衍射（XRD）、傅里叶变换红外光谱（FTIR）和差示扫描量热法（DSC）等分析技术来研究氯氮平与辅料之间的相容性。：优化后的3D打印ODT的崩解时间显著短于压制片，为（9.9±0.7）秒，而压制片的崩解时间为40秒。3D打印ODT的接触角经测量为60.48±0.36°，表明其具有利于崩解的润湿性。扫描电子显微镜（SEM）分析显示3D打印片剂具有多孔结构，孔隙率为48.97%（比压汞仪测定的压制片孔隙率高出两倍多）。：总体而言，这一发现证明了使用基于粉末的3D打印制造无崩解剂的高亲水性和不可膨胀ODT的可行性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/bd8be67b4910/pharmaceutics-17-00435-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/75c318a198a0/pharmaceutics-17-00435-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/a45b303d97b6/pharmaceutics-17-00435-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/5ed835abd54d/pharmaceutics-17-00435-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/6638a94d7fda/pharmaceutics-17-00435-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/f37567664b8a/pharmaceutics-17-00435-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/5647e7c2a289/pharmaceutics-17-00435-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/1bb7a21fc39d/pharmaceutics-17-00435-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/bc5cfc8b112a/pharmaceutics-17-00435-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/bd8be67b4910/pharmaceutics-17-00435-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/75c318a198a0/pharmaceutics-17-00435-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/a45b303d97b6/pharmaceutics-17-00435-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/5ed835abd54d/pharmaceutics-17-00435-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/6638a94d7fda/pharmaceutics-17-00435-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/f37567664b8a/pharmaceutics-17-00435-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/5647e7c2a289/pharmaceutics-17-00435-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/1bb7a21fc39d/pharmaceutics-17-00435-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/bc5cfc8b112a/pharmaceutics-17-00435-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3e3/12030749/bd8be67b4910/pharmaceutics-17-00435-g009.jpg

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