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热熔挤出技术在药物剂型设计中的最新进展

Recent Progress in Hot Melt Extrusion Technology in Pharmaceutical Dosage Form Design.

作者信息

Salave Sagar, Prayag Kedar, Rana Dhwani, Amate Prakash, Pardhe Rupali, Jadhav Ajinkya, Jindal Anil B, Benival Derajram

机构信息

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, India.

Department of Pharmacy, Birla Institute of Technology and Science Pilani (BITS PILANI), Pilani, Rajasthan, India.

出版信息

Recent Adv Drug Deliv Formul. 2022;16(3):170-191. doi: 10.2174/2667387816666220819124605.

DOI:10.2174/2667387816666220819124605
PMID:35986528
Abstract

BACKGROUND

The Hot Melt Extrusion (HME) technique has shown tremendous potential in transforming highly hydrophobic crystalline drug substances into amorphous solids without using solvents. This review explores in detail the general considerations involved in the process of HME, its applications and advances.

OBJECTIVE

The present review examines the physicochemical properties of polymers pertinent to the HME process. Theoretical approaches for the screening of polymers are highlighted as a part of successful HME processed drug products. The critical quality attributes associated with the process of HME are also discussed in this review. HME plays a significant role in the dosage form design, and the same has been mentioned with suitable examples. The role of HME in developing several sustained release formulations, films, and implants is described along with the research carried out in a similar domain.

METHODS

The method includes the collection of data from different search engines like PubMed, ScienceDirect, and SciFinder to get coverage of relevant literature for accumulating appropriate information regarding HME, its importance in pharmaceutical product development, and advanced applications.

RESULTS

HME is known to have advanced pharmaceutical applications in the domains related to 3D printing, nanotechnology, and PAT technology. HME-based technologies explored using Design-of- Experiments also lead to the systematic development of pharmaceutical formulations.

CONCLUSION

HME remains an adaptable and differentiated technique for overall formulation development.

摘要

背景

热熔挤出(HME)技术在不使用溶剂的情况下将高度疏水的结晶药物转化为无定形固体方面显示出巨大潜力。本综述详细探讨了HME过程中涉及的一般考虑因素、其应用和进展。

目的

本综述研究了与HME过程相关的聚合物的物理化学性质。作为成功的HME加工药品的一部分,突出了聚合物筛选的理论方法。本综述还讨论了与HME过程相关的关键质量属性。HME在剂型设计中起着重要作用,并通过合适的例子进行了说明。描述了HME在开发几种缓释制剂、薄膜和植入物中的作用以及在类似领域开展的研究。

方法

该方法包括从不同的搜索引擎如PubMed、ScienceDirect和SciFinder收集数据,以涵盖相关文献,积累有关HME及其在药品开发中的重要性和先进应用的适当信息。

结果

已知HME在与3D打印、纳米技术和PAT技术相关的领域具有先进的药物应用。使用实验设计探索的基于HME的技术也导致了药物制剂的系统开发。

结论

HME仍然是整体制剂开发中一种适应性强且有区别的技术。

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引用本文的文献

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Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach.通过热熔挤出连续制备无溶剂环糊精包合物以提高药物溶解度:一种设计质量方法。
Pharmaceutics. 2023 Aug 25;15(9):2203. doi: 10.3390/pharmaceutics15092203.
2
Factors That Influence Sustained Release from Hot-Melt Extrudates.影响热熔挤出物缓释的因素。
Pharmaceutics. 2023 Jul 20;15(7):1996. doi: 10.3390/pharmaceutics15071996.