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Flexibility of 3D Extruded Printing for a Novel Controlled-Release Puerarin Gastric Floating Tablet: Design of Internal Structure

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Abstract

The objective of this study was to investigate the development of a novel puerarin gastric floating system with a concentric annular internal pattern by a 3D extrusion-based printing technique and to explore the flexibility of turning the release behavior through the design of the internal structure. The composition consisted of the conventional sustained-release pharmaceutical excipients without addition of foaming agent or light materials. First, the proper alcohol/water proportion was selected for the binding agent. The desired drug release behaviors and good floating properties were obtained either through modification of the formulation composition or adjustment of the internal structure. In vitro, the printed tablets were evaluated for drug release, mechanical properties, lag time, and floating duration time. The in vivo behaviors of the formulations were noted at certain time intervals through assessment of the radiographic pictures of healthy volunteers. The gastric retention time in the 3D-printed tablet was approximately 6 h in vivo. Results indicated these puerarin gastric floating 3D-printed tablets had great potential to achieve good gastric residence time and controlled release. Therefore, 3D extrusion-based printing appears to be appropriate for the production of oral administration systems, owing to its flexibility and the great floating ability and controlled-release capacity of its products.

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Acknowledgments

We are grateful for the instrumental support received from JingXin Pharmaceutical Co., Ltd. (Zhejiang, China).

Funding

This work was supported by the National Science and Technology Major Project, belonging to the “Research on the key technology of new drug delivery system and industrialization of new projects” line (no. 2014ZX09507001004), and by the Open fund of the Key Laboratory of the Ministry of Education for TCM Viscera-State Theory and Applications, Liaoning University of Traditional Chinese Medicine, belonging to the “Research of gastro-retentive and control-released preparation of ginkgolide” line (no. zyzx1608).

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Authors and Affiliations

  1. Department of Traditional Chinese Medicine, Shenyang Pharmaceutical University, 103, Wenhua Road, Shenyang, 110016, China

    Pingfei Li

  2. Department of Pharmacy, Shenyang Pharmaceutical University, No. 103 Wenhua Road, Shenyang, 110016, China

    Shiming Zhang, Wenliang Sun, Mengsuo Cui, Haoyang Wen, Qijun Li, Weisan Pan & Xinggang Yang

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  1. Pingfei Li
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Correspondence to Xinggang Yang.

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All procedures involving human participants in this study conformed to the ethical standards of the institutional and/or national research committee and complied with the 1964 Helsinki declaration and its later amendments and with other comparable ethical standards.

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Li, P., Zhang, S., Sun, W. et al. Flexibility of 3D Extruded Printing for a Novel Controlled-Release Puerarin Gastric Floating Tablet: Design of Internal Structure. AAPS PharmSciTech 20, 236 (2019). https://doi.org/10.1208/s12249-019-1455-3

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