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基于载体的干粉吸入器性能优化:综述

Optimization of Carrier-Based Dry Powder Inhaler Performance: A Review.

作者信息

Mehta Tanu, Najafian Saeed, Patel Komalkumar, Lacombe Justin, Chaudhuri Bodhisattwa

机构信息

Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.

Department of Chemical and Biomolecular Engineering, University of Connecticut, Storrs, CT 06269, USA.

出版信息

Pharmaceutics. 2025 Jan 13;17(1):96. doi: 10.3390/pharmaceutics17010096.

Abstract

Dry powder inhalers (DPI's) are becoming increasingly popular due to growing interest in pulmonary drug delivery and their performance is the net result of a series of processes carried out during the formulation development and manufacturing process such as excipient selection, blending, milling, filling, and spray drying. To reach the small airways of the deep lung, the active pharmaceutical ingredients (API) particles need to have an aerodynamic diameter of 1-5 μm to avoid impaction and particle sedimentation in the upper respiratory tract, and due to this small particle size, the powder becomes highly cohesive resulting in poor flow. Therefore, API is usually blended with a coarse carrier to improve flowability, and due to its large size, it is more fluidizable than the micronized drug. Carrier-based DPI formulations usually consist of micronized drugs, a coarse carrier, and additional components, such as micronized lactose and force control agents, including magnesium stearate or leucine. Additionally, the manufacturing process of DPIs relies heavily on powder processing technologies, such as the micronization of API, blending, and powder filling. The aerosol performance of a DPI is significantly affected by the selection of formulation components and the processing of the formulation and, therefore, it is crucial to evaluate these parameters. This review will discuss different factors influencing the aerosol performance of carrier-based DPIs, including formulation components, device considerations, and manufacturing parameters. Additionally, novel technologies pertaining to the optimization of DPI performance are also discussed.

摘要

由于对肺部药物递送的兴趣日益浓厚,干粉吸入器(DPI)越来越受欢迎,其性能是制剂开发和制造过程中一系列操作的最终结果,这些操作包括辅料选择、混合、研磨、填充和喷雾干燥。为了到达肺深部的小气道,活性药物成分(API)颗粒的空气动力学直径需要为1-5μm,以避免在上呼吸道发生撞击和颗粒沉降,并且由于颗粒尺寸小,粉末具有很高的粘性,导致流动性差。因此,API通常与粗载体混合以提高流动性,并且由于其尺寸较大,它比微粉化药物更易流化。基于载体的DPI制剂通常由微粉化药物、粗载体和其他成分组成,如微粉化乳糖和力控制剂,包括硬脂酸镁或亮氨酸。此外,DPI的制造过程严重依赖于粉末加工技术,如API的微粉化、混合和粉末填充。DPI的气溶胶性能受制剂成分的选择和制剂加工的显著影响,因此,评估这些参数至关重要。本综述将讨论影响基于载体的DPI气溶胶性能的不同因素,包括制剂成分、装置考量和制造参数。此外,还讨论了与优化DPI性能相关的新技术。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c2f/11768101/94d0aa308f9d/pharmaceutics-17-00096-g001.jpg

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