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制药生产中熔融沉积成型的加载技术进展与设计质量:一项系统综述。

Advances in Loading Techniques and Quality by Design for Fused Deposition Modeling in Pharmaceutical Production: A Systematic Review.

作者信息

Ahmed Yusra, Mahmoud Azza A K, Ludasi Krisztina, Sovány Tamás

机构信息

Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u 6, H-6720 Szeged, Hungary.

出版信息

Pharmaceuticals (Basel). 2024 Nov 7;17(11):1496. doi: 10.3390/ph17111496.

Abstract

BACKGROUND/OBJECTIVES: Three-dimensional printing technology has emerging interest in pharmaceutical manufacturing, offering new opportunities for personalized medicine and customized drug delivery systems. Fused deposition modeling (FDM) is highly regarded in the pharmaceutical industry because of its cost effectiveness, easy operation, and versatility in creating pharmaceutical dosage forms. This review investigates different methods of incorporating active pharmaceutical ingredients (APIs) into filament matrices for use in fused deposition modeling (FDM) 3D printing.

METHODS

Two electronic databases, the Web of Science and PubMed, were utilized to survey the literature. The selected keywords for this review were as follows: fused filament fabrication OR fused deposition modeling OR FDM OR FFF AND 3D printing AND loading techniques OR impregnation techniques AND solid dosage form.

RESULTS

This paper evaluates various loading techniques such as soaking, supercritical impregnation, microwave impregnation, and hot-melt extrusion, focusing on their effectiveness and capacity for drug incorporation. Additionally, this review includes a thorough risk assessment of the extrusion process using Ishikawa and SWOT analyses.

CONCLUSIONS

Overall, this review provides comprehensive insights into the latest advancements in 3D printing for pharmaceutical applications and identifies key areas for future research and development.

摘要

背景/目的:三维打印技术在制药生产中越来越受关注,为个性化医疗和定制药物递送系统提供了新机遇。熔融沉积建模(FDM)因其成本效益高、操作简便以及在制造药物剂型方面的多功能性而在制药行业备受推崇。本综述研究了将活性药物成分(API)纳入丝状基质以用于熔融沉积建模(FDM)3D打印的不同方法。

方法

利用两个电子数据库,即科学网和PubMed,对文献进行检索。本综述选定的关键词如下:熔融长丝制造或熔融沉积建模或FDM或FFF以及3D打印以及加载技术或浸渍技术以及固体剂型。

结果

本文评估了各种加载技术,如浸泡、超临界浸渍、微波浸渍和热熔挤出,重点关注它们在药物掺入方面的有效性和能力。此外,本综述还使用石川图和SWOT分析对挤出过程进行了全面的风险评估。

结论

总体而言,本综述全面深入地介绍了3D打印在制药应用中的最新进展,并确定了未来研发的关键领域。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ea3/11597217/6cc5b233e9f0/pharmaceuticals-17-01496-g001.jpg

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