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共喷雾干燥技术制备的干粉吸入制剂的最新进展:综述

Recent advances in dry powder inhalation formulations prepared by co-spray drying technology: a comprehensive review.

作者信息

Chen Xian, Huang Zhengwei, Zhang Xuejuan, Pan Xin, Wu Chuanbin, Jiang Junhuang

机构信息

State Key Laboratory of Bioactive Molecules and Druggability Assessment, Jinan University, Guangzhou 510632, China.

State Key Laboratory of Bioactive Molecules and Druggability Assessment, Jinan University, Guangzhou 510632, China.

出版信息

Int J Pharm. 2025 Aug 20;681:125825. doi: 10.1016/j.ijpharm.2025.125825. Epub 2025 Jun 8.

Abstract

Co-spray drying technology represents an increasingly important approach in preparing dry powder inhalation (DPI) formulations. Compared to conventional spray drying, co-spray drying typically yields particles characterized by improved aerosol performance and enhanced physicochemical stability. Despite its widespread application over the past decades, this technology remains under-represented in literature reviews. Therefore, we proposed to bridge the gap between co-spray drying and DPIs. In this review, we first elucidate the mechanism underlying co-spray drying as well as the critical process parameters impacting its effectiveness. We subsequently compile a list of commonly employed excipients utilized during the co-spray drying process. Thereafter, we summarize analytical techniques pivotal in evaluating DPIs performance, such as aerodynamic performance, solid state characterization, alongside relevant analyses pertaining to different drug molecules. Furthermore, this review provides a comprehensive overview of diverse applications of co-spray drying across various drug modalities, including small molecules, peptides, proteins, and gene therapy. More importantly, this technique has demonstrated significant potential in delivering biologics locally to treat pulmonary diseases. Additionally, we explore the growing significance and feasibility of integrating Artificial Intelligence and machine learning in developing DPIs prepared by co-spray drying, thereby substantially facilitating the formulation development of co-spray dried DPIs.

摘要

共喷雾干燥技术是制备干粉吸入剂(DPI)制剂中一种日益重要的方法。与传统喷雾干燥相比,共喷雾干燥通常产生的颗粒具有改善的气溶胶性能和增强的物理化学稳定性。尽管在过去几十年中该技术得到了广泛应用,但在文献综述中对其的介绍仍然较少。因此,我们提议弥合共喷雾干燥与干粉吸入剂之间的差距。在本综述中,我们首先阐明共喷雾干燥的潜在机制以及影响其有效性的关键工艺参数。随后,我们编制了一份共喷雾干燥过程中常用辅料的清单。此后,我们总结了评估干粉吸入剂性能的关键分析技术,如空气动力学性能、固态表征以及与不同药物分子相关的分析。此外,本综述全面概述了共喷雾干燥在各种药物类型中的不同应用,包括小分子、肽、蛋白质和基因治疗。更重要的是,该技术在局部递送生物制剂治疗肺部疾病方面已显示出巨大潜力。此外,我们探讨了在开发通过共喷雾干燥制备的干粉吸入剂过程中整合人工智能和机器学习的日益重要性和可行性,从而极大地促进共喷雾干燥干粉吸入剂的制剂开发。

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