Shanghai Sine Pharmaceutical Laboratories Co. Ltd., Shanghai, China.
J Aerosol Med Pulm Drug Deliv. 2024 Oct;37(5):232-240. doi: 10.1089/jamp.2023.0050. Epub 2024 Jul 15.
The lack of visual dynamic spray characterization has made the understanding of the physical processes governing atomization and drug particle formation difficult. This study aimed to investigate the changes in the spray plume morphology and aerodynamic particle size of solution-based pressurized metered-dose inhalers (pMDIs) under different conditions to achieve better drug deposition. Solution-based pMDIs were studied, and the effects of various factors, such as propellant concentration, orifice diameters, and atomization chamber volume, on drug deposition were examined by analyzing the characteristics of spray plume and aerodynamic particle size. Reducing the actuator orifice and spray area led to a concentrated spray plume and increased duration and speed. Moreover, the aerodynamic particle sizes D50 and D90 decreased, whereas D10 remained relatively unchanged. Decreasing the atomization chamber volume of the actuator led to reduced spray area and an increased duration but a decreased plume velocity. D90 exhibited a decreasing trend, whereas D10 and D50 remained relatively unchanged. Reducing the propellant concentration in the prescription, the spray area and the plume velocity first decreased and then increased. The duration initially increased and then decreased. The values of D50 and D90 showed an initial decreasing followed by an increasing trend, whereas D10 remained relatively unchanged. During the development process, attention should be paid to the changes in the spray area, spray angle, duration, and speed of the spray plume. This study recommended analyzing the characteristics of the spray plume and combining the data of two or more aerodynamic particle size detection methods to verify the deposition to achieve rapid screening and obtain high lung deposition .
缺乏可视化动态喷雾特性研究使得人们难以理解控制雾化和药物颗粒形成的物理过程。本研究旨在探讨不同条件下溶液型定量吸入气雾剂(pMDI)喷雾羽流形态和空气动力学粒径的变化,以实现更好的药物沉积。研究了溶液型 pMDI,并通过分析喷雾羽流和空气动力学粒径的特性,考察了推进剂浓度、喷嘴直径和雾化腔体积等各种因素对药物沉积的影响。减小致动器喷嘴和喷雾区域会导致喷雾羽流更加集中,喷雾持续时间和速度增加。此外,空气动力学粒径 D50 和 D90 减小,而 D10 相对不变。减小致动器雾化腔体积会导致喷雾区域减小,喷雾持续时间增加,但喷雾羽流速度降低。D90 呈下降趋势,而 D10 和 D50 相对不变。降低处方中的推进剂浓度,喷雾区域和羽流速度先减小后增大。喷雾持续时间先增加后减小。D50 和 D90 的值先减小后增大,而 D10 相对不变。在开发过程中,应注意喷雾区域、喷雾角度、喷雾羽流持续时间和速度的变化。本研究建议分析喷雾羽流的特性,并结合两种或更多空气动力学粒径检测方法的数据,以验证沉积情况,实现快速筛选并获得高肺部沉积。