Berry Julianne, Heimbecher Susan, Hart John L, Sequeira Joel
Schering Plough Research Institute, Kenilworth, New Jersey 07033, USA.
Drug Dev Ind Pharm. 2003 Sep;29(8):865-76. doi: 10.1081/ddc-120024182.
Presented in this work are the results of a study designed to investigate the impact of the valve metering chamber volume and actuator design on the aerodynamic particle size distribution (PSD) of a suspension metered dose inhaler (MDI) containing propellant HFA-227. It was hypothesized that the valve metering volume and the actuator design in the MDI could influence the PSD of the emitted dose since it would affect the aerosol spray dynamics. The PSD results from this study, measured using cascade impaction, revealed that samples containing an actuator intended for oral delivery (rectangular mouthpiece and orifice diameter of approximately 0.5 mm) produced a higher fine particle dose (FPD) than those containing an actuator intended for nasal delivery (circular nosetip and orifice diameter of approximately 1 mm). In addition, the drug PSD profile was shown to be more sensitive to differences in the particle size of the suspended material when the oral actuator was used compared to when the nasal actuator was used. The valve metering chamber (25 vs. 63 microL volume) did not appear to have a major effect on the product aerodynamic PSD or the droplet size. These results demonstrate the importance of actuator design and orifice size in determining the aerodynamic PSD of an MDI.
本研究旨在探讨阀门计量腔体积和促动器设计对含推进剂HFA - 227的混悬型定量吸入器(MDI)空气动力学粒径分布(PSD)的影响。研究假设,MDI中的阀门计量体积和促动器设计会影响喷出剂量的PSD,因为这会影响气溶胶喷雾动力学。本研究使用多级冲击采样法测量PSD的结果显示,含有用于口腔给药的促动器(矩形吸嘴,孔径约0.5毫米)的样品产生的细颗粒剂量(FPD)高于含有用于鼻腔给药的促动器(圆形鼻罩,孔径约1毫米)的样品。此外,与使用鼻腔促动器相比,使用口腔促动器时,药物PSD曲线对悬浮材料粒径差异更为敏感。阀门计量腔(体积为25微升与63微升)似乎对产品空气动力学PSD或液滴大小没有重大影响。这些结果证明了促动器设计和孔径大小在决定MDI空气动力学PSD方面的重要性。