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Preparation of High-Drug-Loaded Clarithromycin Gastric-Floating Sustained-Release Tablets Using 3D Printing

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Abstract

The high-drug-loaded sustained-release gastric-floating clarithromycin (CAM) tablets were proposed and manufactured via semisolid extrusion (SSE)-based 3D printing. The physical and mechanical properties, such as dimensions, weight variation, friability, and hardness, were accessed according to the quality standards of Chinese Pharmacopoeia (Ch.P). The interactions among the drug-excipients were evaluated via differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FTIR), and X-ray diffraction (XRD) techniques. Next, the rheological properties of the paste and the effect of the excipients and solvents were evaluated. Finally, a very high drug-loading of up to 81.7% (w/w) with the sustain release time of 8 h (125 mg) and 12 h (250 mg) was achieved. The results revealed the potential of SSE for achieving a high drug loading and identified the suitable properties of the paste for SSE-based 3D printing.

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Acknowledgements

This work was supported by Guangdong “Climbing” Program for Undergraduates (Grant Number PDJH2020a0298); Guangdong Graduate Education Innovation Program: Project Funded by Guangdong Province Joint Training Graduate Demostration Base (Guangzhou General Pharmaceutical Research Institute Co., Ltd.) Guangdong Pharmaceutical University “Innovation and Enhancing Project”; and Guangzhou Science and Technology Program key projects(Grant Number 20170402199, 201903010002).

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Author notes

  1. Peihong Chen and Siyu Huang contributed equally to this study and should be regarded as first authors.

Authors and Affiliations

  1. Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China

    Peihong Chen, Haosen Luo, Siyu Huang, Jinling Liu, Minmei Lin, Fan Yang, Junfeng Ban, Zeju Huang, Zhufen Lu, Qingchun Xie & YanZhong Chen

  2. Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China

    Siyu Huang, Fan Yang, Junfeng Ban, Zhufen Lu, Qingchun Xie & YanZhong Chen

  3. Guangdong Provincial Engineering Center of Topical Precision Drug Delivery System, Center for Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou, People’s Republic of China

    Siyu Huang, Fan Yang, Junfeng Ban, Zhufen Lu, Qingchun Xie & YanZhong Chen

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  1. Peihong Chen
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Chen, P., Luo, H., Huang, S. et al. Preparation of High-Drug-Loaded Clarithromycin Gastric-Floating Sustained-Release Tablets Using 3D Printing. AAPS PharmSciTech 22, 131 (2021). https://doi.org/10.1208/s12249-021-01994-z

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