吸气模式对吸入粉雾剂模型体外沉积性能的影响

Effect of Inhalation Profiles on the in vitro Deposition Performance of Dry Powder Inhaler Models

研究了吸气峰值流速和吸气加速度对3种含不同比例细粉乳糖的吸入粉雾剂(DPI)模型体外沉积性能的影响。将布地奈德与乳糖载体和细粉乳糖混合,制得3种处方模型(处方A的细粉乳糖比例为10%,处方B为5%,处方C不含细粉乳糖)。采用阿尔伯塔理想化口喉模型和新一代撞击器系统来评价DPI模型的沉积性能。在30、60和90 L/min的吸气峰值流速下进行测试,并使用了2个分别代表“快速”和“慢速”的吸气加速度条件。结果显示,处方A和B的总肺部沉积量都显示出对吸气峰值流速的依赖性(P<0.05);处方C的总肺部沉积量虽不受吸气峰值流速的影响,但受到吸气加速度的影响程度最大。此外,3种处方在“快速”吸气加速度下的小气道沉积量均显著高于在“慢速”吸气加速度下的结果(P<0.05)。由此可见,除了吸气峰值流速之外,吸气加速度也是影响DPI体外性能的重要因素。在本研究范围内,细粉乳糖比例升高可改善处方沉积性能,且受到吸气加速度影响的敏感性降低,但会更依赖于吸气峰值流速。

The effects of peak inhalation flow rate(PIFR) and flow increase rate(FIR) on the in vitro deposition performance of three dry powder inhaler(DPI) models with different fine lactose ratios were investigated.Three formulations(formulation A with a fine lactose ratio of 10%,formulation B of 5%,and formulation C without fine lactose) were prepared by mixing budesonide with coarse lactose carrier and fine lactose.The efficiency of particle deposition was assessed by using the Alberta idealized mouth-throat model and a next generation impactor system.In vitro testing was performed at PIFRs of 30,60,and 90 L/min and two FIRs(representing fast and slow inhalation conditions,respectively).The total lung dose(TLD) of formulations A and B showed a dependence on PIFR;but the TLD of formulation C which was not affected by PIFR was most affected by FIR.In addition,the small airways dose(SAD) of all three formulations was significantly higher at fast FIR than those at slow FIR(P<0.05).In addition to PIFR,FIR was an important factor affecting the in vitro performance of DPI.Within the scope of the experiments in this study,the fine lactose ratio of the formulations had a positive correlation with the deposition performance,showing a lower sensitivity to the FIR,but was more dependent on the PIFR.