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The Exploration of a Novel Biodegradable Drug-Eluting Biliary Stent: Preliminary Work

  • Laboratory Investigation
  • Biliary
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

To explore the degradation, drug release, and mechanical properties of drug-incorporated films made of different ratios of poly(lactic-co-glycolic acid) (PLGA) and different amounts of paclitaxel (PTX), which may serve as the material platform for the manufacturing of biodegradable drug-eluting biliary stents.

Materials and Methods

PLGA of different lactic acid/glycolic acid ratios (50/50, 70/30, and 80/20) and 0%, 10, 20, and 30% weight by weight (w/w) PTX was mixed to make PLGA films, which were then cut into small pieces for further testing. Films were immersed in phosphate-buffered saline (pH 7.4) for a maximum of 11 weeks. Samples were taken randomly at Day 2, 4, 6, 8, 10, 12, 14, and weekly thereafter until Week 11 to test tensile strength, weight loss, pH value of the soaking solution, and drug release. The morphology of films was observed using scanning electron microscope (SEM).

Results

At Week 10 of degradation, PLGA 80/20 still withstood a tensile strength of 9.7 newton (N), while PLGA 50/50 and 70/30 cracked spontaneously since Day 4. At Week 11, weight loss of PLGA 50/50, 70/30, and 80/20 was 95.15, 82.32, and 16.17%, respectively; and the lowest pH value of soaking solution was 1.87, 1.95, and 6.58, respectively. Drug release of 10, 20, and 30% PTX groups was 3.52–4.48%, 1.90–2.26%, and 1.44–2.06%, respectively. SEM proved smooth films before degradation; however, after the tensile strength was lost, cracks could be seen.

Conclusion

The degradation rate of PLGA can be controlled by altering lactic acid/glycolic acid ratio. Overall, PLGA 50/50 and 70/30 degrade significantly faster than 80/20. PLGA can serve as an effective drug carrier for PTX while being the stent strut, and PTX can be slowly released as PLGA degrades.

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Acknowledgements

The authors thank Dr. Li-Gong Lu (Zhuhai People's Hospital, Zhuhai Hospital of Jinan University), Dr. Lei Chen (The Affiliated Suzhou Hospital of Nanjing Medical University), Dr. Jia-Jie Ji (Zhongda Hospital, Southeast University), Mr. Xiang-Man Zhang [Heng Rui Callisyn Biomedical (Suzhou) Co., Ltd.], and Mr. Xiao-Lei Gu [Heng Rui Callisyn Biomedical (Suzhou) Co., Ltd.] for their assistance in carrying out the study.

Funding

This study was supported by the National Natural Science Foundation of China (81441054, 81671796) and the Jiangsu Provincial Medical Youth Talent Program (ZDRCA2016078). The funders had no role in study design, data analysis, decision to publish, or preparation of the manuscript.

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Authors and Affiliations

  1. Center of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, School of Medicine, Southeast University, 87 Dingjiaqiao Road, Nanjing, 210009, China

    Chu-Hui Zeng, Lin-Lin Liu, Hai-Dong Zhu & Gao-Jun Teng

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  1. Chu-Hui Zeng
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Correspondence to Hai-Dong Zhu or Gao-Jun Teng.

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Zeng, CH., Liu, LL., Zhu, HD. et al. The Exploration of a Novel Biodegradable Drug-Eluting Biliary Stent: Preliminary Work. Cardiovasc Intervent Radiol 44, 1633–1642 (2021). https://doi.org/10.1007/s00270-021-02892-4

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  • DOI: https://doi.org/10.1007/s00270-021-02892-4

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