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3D 打印技术在定制药物传递系统中的应用:现状、前景与挑战。

3D Printing Technology in Customized Drug Delivery System: Current State of the Art, Prospective and the Challenges.

机构信息

Sri Indu Institute of Pharmacy, Hyderabad, India.

Department of Pharmaceutical Sciences, College of Pharmacy, Shaqra University, AD-Dawadmi, Riyadh, Saudi Arabia.

出版信息

Curr Pharm Des. 2018;24(42):5049-5061. doi: 10.2174/1381612825666190110153742.

DOI:10.2174/1381612825666190110153742
PMID:30636582
Abstract

BACKGROUND

3D printing/Additive Manufacturing seems a pragmatic approach to realize the quest for a truly customized and personalized drug delivery. 3DP technology, with innovations in pharmaceutical development and an interdisciplinary approach to finding newer Drug Delivery Systems can usher a new era of treatments to various diseases. The true potential of this is yet to be realized, and the US-FDA is focusing on the regulatory science of 3D printed medical devices to help patients access this technology safely and effectively. The approval of the first 3D printed prescription medicine by FDA is a promising step in the translation of more research in this area.

METHODS

A web-search on PubMed, ScienceDirect, and Nature was performed with the keywords Customized 3D printing and Drug delivery, publications dealing with the aspects of drug delivery using 3D printing for personalized or customized delivery were further considered and analyzed and discussed.

RESULTS

We present the advantages offered by 3DP over conventional methods of formulation development and discuss the current state of 3DP in pharmaceutics and how it can be used to develop a truly customized drug delivery system, various 3DP technologies including Stereolithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modelling (FDM), Pressure Assisted Microsyringe (PAM) that have been used to develop pharmaceutical products have been discussed along with their limitations and also the regulatory considerations to help formulation scientists envisaging research in this area with the necessary information.

CONCLUSION

3D printing has the potential to fabricate a customized drug delivery system. Presence of many drug formulation and the devices are already in the regulatory approval process indicating its success.

摘要

背景

3D 打印/增材制造似乎是实现真正定制化和个性化药物输送的实用方法。3DP 技术在药物开发方面的创新以及寻找新型药物输送系统的跨学科方法,可以开创各种疾病治疗的新时代。这项技术的真正潜力尚未实现,美国 FDA 专注于 3D 打印医疗器械的监管科学,以帮助患者安全有效地获得这项技术。FDA 批准首个 3D 打印处方药是该领域更多研究转化的一个有希望的步骤。

方法

在 PubMed、ScienceDirect 和 Nature 上进行了关键词为“定制 3D 打印和药物输送”的网络搜索,进一步考虑和分析了与使用 3D 打印进行个性化或定制输送的药物输送方面的出版物,并进行了讨论。

结果

我们展示了 3DP 相对于传统制剂开发方法的优势,并讨论了 3DP 在药剂学中的现状,以及如何将其用于开发真正的定制化药物输送系统。讨论了各种 3DP 技术,包括立体光刻(SLA)、选择性激光烧结(SLS)、熔融沉积成型(FDM)、压力辅助微注射器(PAM),这些技术已被用于开发制药产品,以及它们的局限性和监管考虑因素,以帮助制剂科学家在该领域进行研究,提供必要的信息。

结论

3D 打印有可能制造定制化药物输送系统。许多药物制剂和设备已经在监管审批过程中,表明其取得了成功。

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