Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria 3052, Australia.
Int J Pharm. 2011 Dec 12;421(1):72-81. doi: 10.1016/j.ijpharm.2011.09.024. Epub 2011 Sep 21.
The purpose of the current investigation is to understand the kinetics of de-agglomeration (k(d)) of micronised salbutamol sulphate (SS) and lactohale 300 (LH300) under varying air flow rates (30-180l min(-1)) from three dry powder inhaler devices (DPIs), Rotahaler (RH), Monodose Inhaler (MI) and Handihaler (HH).
Cumulative fine particle mass vs. time profiles were obtained from the powder concentration, emitted mass and volume percent <5.4 μm, embedded in the particle size distributions of the aerosol at specific times. The rate of de-agglomeration (k(d)), estimated from non-linear least squares modelling, increased with increasing air flow rates. The k(d)vs. air flow rate profiles of SS and LH300 were significantly different at high air flow rates. The k(d) was highest from RH and lowest from MI. Differences in k(d) between the devices were related to device mode of operation while the differences between the materials were due to the powder bed structure.
This approach provided a methodology to measure the rate constant for cohesive powder de-agglomeration following aerosolisation from commercial devices and an initial understanding of the influence of device, air flow rate and material on these rate constants.
本研究旨在了解三种干粉吸入器(Rotahaler(RH)、单剂量吸入器(MI)和 Handihaler(HH))在不同空气流速(30-180l min(-1))下,微米化硫酸沙丁胺醇(SS)和乳糖海 300(LH300)的解团聚动力学(k(d))。
从粉末浓度、发射质量和体积百分比<5.4μm 中获得了随时间变化的累积细颗粒质量与时间的关系曲线,这些数据嵌入在气溶胶的粒径分布中。通过非线性最小二乘法建模估算的解团聚速率(k(d))随着空气流速的增加而增加。在高空气流速下,SS 和 LH300 的 k(d)与空气流速曲线显著不同。RH 的 k(d)最高,MI 的 k(d)最低。设备之间的 k(d)差异与设备的操作模式有关,而材料之间的差异则归因于粉末床结构。
该方法提供了一种测量从商业设备气溶胶化后粘性粉末解团聚速率常数的方法,并初步了解了设备、空气流速和材料对这些速率常数的影响。