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含有贝克罗梅他二 propionate 的计量剂量吸入器的配方,采用通过设计的质量方法

Tu Man Tieu^1,2, Van-Hoa Huynh³, Thai-Duong Nguyen⁴

¹Department of Pharmaceutics, School of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, 41-43 Dinh Tien Hoang, Ho Chi Minh, Vietnam.

Drug development and industrial pharmacy

|February 24, 2026

概括

通过设计质量 (QbD) 方法成功优化了一种通用贝克洛美沙二 propionate计量剂量吸入器 (MDI). 这一框架加速了开发,提高了产品的可靠性,改善了患者获得负担得起的皮质类固醇吸入器的机会.

科学领域:

制药科学制药科学
药物输送系统药物输送系统
吸入疗法是一种吸入疗法.

背景情况:

带有皮质类固醇的计量剂量吸入器 (MDIs) 对喘和COPD管理至关重要.
品牌MDIs的高成本阻碍了获取,特别是在发展中国家.
需要通用替代品来提高负担能力和可访问性.

研究的目的:

开发和优化使用设计质量 (QbD) 方法开发和优化一种通用贝克洛美沙二 propionate MDI配方.
建立关键质量属性 (CQA) 并定义关键配方参数的设计空间.
确保产品质量和性能一致,以提供具有成本效益的仿制品替代品.

主要方法:

应用了QbD原则来制备贝克罗梅他二 propionate MDI.
通过风险评估确定了CQA.
使用的混合物/I-优化设计以优化乙醇,油酸和HFA-134a推进剂水平.
采用统计建模 (设计专家) 来定义控制和优化配方空间.

主要成果:

优化的配方实现了质量中介气动直径 (MMAD),细颗粒分数 (FPF) 和递送剂量均性 (DDU) 的目标规格.
MMAD: 3.26 ± 0.17 微米 (目标<5 微米); FPF: 60.4 ± 2% (目标≥55%); DDU: 99.7 ± 1.5% (目标: 75-125%).
预测模型的准确性很高 (MMAD,FPF和DDU的R2值为0.98,0.88和0.93).

结论:

该QbD方法促进了创建一个强大的设计空间,一个通用贝克洛美二 propionate MDI.
优化的通用MDI配方表现出与参考产品可比的性能.
这项研究支持开发更实惠的吸入性皮质类固醇疗法,提高患者的获取.

关键词:

贝克洛梅他二 propionate 的使用方法开发仿制药的药物开发吸入性皮质类固醇的使用.用计量剂量吸入器的吸入器从设计开始的质量.

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