An Exploration of Dissolution Tests for Inhalation Aerosols

IF 3.4 4区医学 Q2 PHARMACOLOGY & PHARMACY AAPS PharmSciTech Pub Date : 2024-10-01 DOI:10.1208/s12249-024-02951-2

Min Wang, Zhaoying Fang, Kunhao Yang, Xiaowei Guo, Shangyang Li, Ali Liu

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Abstract

This study aimed to establish a feasible dissolution method for inhalation aerosols. A method of collecting fine particles was investigated to capture aerosol particles less than 4 μm in diameter for dissolution tests. This dose collection method enabled the aerosol particles to be uniformly distributed on the glass fiber filter, thus considerably reducing particle agglomeration. Budesonide was used as a model drug. The aerodynamic particle size distribution (APSD) of the meter-dose inhaler (MDI) was compared by replacing actuators with different orifice sizes. Dissolution tests were conducted on fine particle doses collected using various actuators, and the dissolution profiles were modeled. The fine particle dose decreased with an increasing orifice size of the actuator. Actuators with different orifice sizes would affect the dissolution behavior of inhaled drugs. This finding was supported by similarity factor f₂ analysis, suggesting the dissolution method has a discriminative capacity. The results of various model fits showed that the dissolution profiles produced by the different actuators could be fitted well using the Weibull mathematical model. The method employed in this study could offer a potential avenue for exploring the relationship between the orifice size of the actuator and the dissolution behavior of inhaled corticosteroids. This dissolution method was simple, reproducible, and suitable for determining the dissolution of inhalation aerosols.

Graphical Abstract

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吸入气溶胶溶解试验探索。

本研究旨在为吸入气溶胶建立一种可行的溶解方法。研究了一种收集细颗粒的方法，以捕获直径小于 4 μm 的气溶胶颗粒进行溶解试验。这种剂量收集方法能使气溶胶颗粒均匀地分布在玻璃纤维过滤器上，从而大大减少了颗粒的聚集。布地奈德被用作模型药物。通过更换不同孔径的致动器，比较了计量吸入器（MDI）的气动粒径分布（APSD）。对使用不同致动器收集的细颗粒剂量进行了溶出试验，并建立了溶出曲线模型。细颗粒剂量随着致动器孔径的增加而减少。不同孔径的致动器会影响吸入药物的溶解行为。相似性因子 f2 分析支持了这一结论，表明溶解方法具有鉴别能力。各种模型拟合的结果表明，使用 Weibull 数学模型可以很好地拟合不同致动器产生的溶出曲线。本研究采用的方法为探索致动器孔径大小与吸入皮质类固醇溶出行为之间的关系提供了一个潜在的途径。这种溶出方法简单、可重复，适用于测定吸入气溶胶的溶出。

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来源期刊

AAPS PharmSciTech 医学-药学

CiteScore

6.80

自引率

3.00%

发文量

264

审稿时长

2.4 months

期刊介绍： AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.