热熔挤压技术在药物剂型设计中的最新进展。

Sagar Salave, Kedar Prayag, Dhwani Rana, Prakash Amate, Rupali Pardhe, Ajinkya Jadhav, Anil B Jindal, Derajram Benival
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引用次数: 3

摘要

背景:热熔挤压(HME)技术在不使用溶剂的情况下将高疏水性结晶药物转化为无定形固体方面显示出巨大的潜力。本文对HME过程中涉及的一般问题、HME的应用和进展进行了详细的探讨。目的:综述了与HME工艺相关的聚合物的理化性质。聚合物筛选的理论方法被强调为成功的HME加工药物产品的一部分。本文还讨论了与HME过程相关的关键质量属性。HME在剂型设计中起着重要的作用,并以合适的实例进行了介绍。HME在开发几种缓释制剂、薄膜和植入物中的作用,以及在类似领域进行的研究。方法:从PubMed、ScienceDirect、SciFinder等不同的搜索引擎中收集数据,覆盖相关文献,积累关于HME、HME在医药产品开发中的重要性和高级应用的适当信息。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制药应用。利用实验设计探索的基于hme的技术也导致了药物配方的系统开发。结论:HME仍然是一种适应性强、差异化强的整体处方开发技术。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Recent Progress in Hot Melt Extrusion Technology in Pharmaceutical Dosage Form Design.

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.

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