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Preparation and In vitro Evaluation of FDM 3D-Printed Ellipsoid-Shaped Gastric Floating Tablets with Low Infill Percentages

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Abstract

The aim of the study is to investigate the feasibility of fabricating FDM 3D-printed gastric floating tablets with low infill percentages and the effect of infill percentage on the properties of gastric floating tablets in vitro. Propranolol hydrochloride was selected as a model drug, and drug-loaded polyvinyl alcohol (PVA) filaments were produced by hot melt extrusion (HME). Ellipsoid-shaped gastric floating tablets with low infill percentage of 15% and 25% (namely E-15 and E-25) were then prepared respectively by feeding the extruded filaments to FDM 3D printer. Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray powder diffraction (XRD), and scanning electron microscopy (SEM) were employed to characterize the filaments and 3D-printed tablets, and a series of evaluations were performed to the 3D-printed tablets, including the weight variation, drug content, hardness, in vitro floating behavior, and drug release of the tablets. The SEM results showed that the drug-loaded filaments and 3D-printed tablets appeared intact without defects, and the printed tablets were composed of filaments deposited uniformly layer by layer. The model drug and the excipients were thermally stable under the process temperature of extruding and printing, with a small amount of drug crystals dispersing in the drug-loaded filaments and 3D-printed tablets. Both E-15 and E-25 could float on artificial gastric fluids without any lag time and released in a sustained manner. Compared with E-15, the E-25 presented less weight variation, higher tablet hardness, shorter floating time, and longer drug release time.

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Author notes

  1. Di Chen and Xiang-Yu Xu contributed equally to this work.

Authors and Affiliations

  1. The State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University, Beijing, 100191, China

    Di Chen, Rui Li, Yue Zhang, Ming-Rui Wang, Meng-Fei Xiong, Jia-Rui Xu, Ting Wang & Tian-Yuan Fan

  2. Beijing Key Laboratory of Molecular Pharmaceutics and New Drug Delivery Systems, School of Pharmaceutical Sciences, Peking University, Beijing, 100191, China

    Di Chen, Rui Li, Yue Zhang, Ming-Rui Wang, Meng-Fei Xiong, Jia-Rui Xu, Ting Wang & Tian-Yuan Fan

  3. School of Mechanical Engineering and Automation, Beihang University, Beijing, 100191, China

    Xiang-Yu Xu, Gen-Ao Zang & Guang-Rong Yan

  4. Beijing Institute for Drug Control, Beijing, 102206, China

    Hui Fu, Qin Hu & Bin Wu

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  1. Di Chen
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Correspondence to Guang-Rong Yan or Tian-Yuan Fan.

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Chen, D., Xu, XY., Li, R. et al. Preparation and In vitro Evaluation of FDM 3D-Printed Ellipsoid-Shaped Gastric Floating Tablets with Low Infill Percentages. AAPS PharmSciTech 21, 6 (2020). https://doi.org/10.1208/s12249-019-1521-x

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