An Exploration of Dissolution Tests for Inhalation Aerosols
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.
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Materials
Budesonide inhalation aerosol(Solution-based inhalation aerosol) formulated with Budesonide, ethanol (solvent), 1,1,1,2-tetrafluoroethane (propellant), glycerol (stabilizer). Anhydrous disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, and sodium chloride (China National Pharmaceutical Group Chemical Reagent Co., Ltd.; analytical grade). Polysorbate 80 (China National Pharmaceutical Group Chemical Reagent Co., Ltd.; pharmaceutical grade). Methanol, acetonitrile (Sigma, Gillingham, UK; HPLC grade). Glass fiber filter (77 mm diameter, 0.3 μm pore size; Beijing Huironghe Technology Co., Ltd.).polytetrafluoroethylene filter (0.45 µm; Germany MEMBRANA GmbH). The water used for the experiments was ultrapure water.
Wang, M., Fang, Z., Yang, K. et al. An Exploration of Dissolution Tests for Inhalation Aerosols. AAPS PharmSciTech 25, 230 (2024). https://doi.org/10.1208/s12249-024-02951-2