Drug Delivery, Disposition and Dynamics Monash Institute of Pharmaceutical Sciences, Monash University (Parkville campus), 381 Royal Parade, Parkville, Victoria, 3052, Australia.
Pharm Res. 2012 Oct;29(10):2926-35. doi: 10.1007/s11095-012-0799-0. Epub 2012 Jun 14.
The purpose was to calculate distributions of powder strength of a cohesive bed to explain the de-agglomeration of lactose.
De-agglomeration profiles of Lactohale 300(®) (L300) and micronized lactose (ML) were constructed by particle sizing aerosolised plumes dispersed at air flow rates of 30-180 l/min. The work of cohesion distribution was determined by inverse gas chromatography. The primary particle size and tapped density distributions were determined. Powder strength distributions were calculated by Monte Carlo simulations from distributions of particle size, work of cohesion and tapped density measurements.
The powder strength distribution of L300 was broader than that of ML. Up to 85th percentile, powder strength of L300 was lower than ML which was consistent with the better de-agglomeration of L300 at low flow rates. However, ~15% of L300 particles had higher powder strength than ML which likely to cause lower de-agglomeration for L300 at high air flow rates.
Cohesive lactose powders formed matrices of non-homogenous powder strength. De-agglomeration of cohesive powders has been shown to be related to powder strength. This study provided new insights into powder de-agglomeration by a new approach for calculating powder strength distributions to better understand complex de-agglomeration behaviour.
目的是计算粘性床粉末强度的分布,以解释乳糖的解团聚。
通过在 30-180 l/min 的气流速度下分散气溶胶化羽流来构建 Lactohale 300(®)(L300)和微粉化乳糖(ML)的解团聚曲线。通过反气相色谱法确定结合能分布的功。测定了初级粒径和振实密度分布。通过从粒径、结合能和振实密度测量的分布进行蒙特卡罗模拟计算了粉末强度分布。
L300 的粉末强度分布比 ML 的更宽。在达到第 85 个百分位数时,L300 的粉末强度低于 ML,这与 L300 在低流速下更好的解团聚一致。然而,约 15%的 L300 颗粒具有比 ML 更高的粉末强度,这可能导致 L300 在高气流速率下的解团聚较低。
粘性乳糖粉末形成了不均匀粉末强度的基质。已经表明,粘性粉末的解团聚与粉末强度有关。本研究通过计算粉末强度分布的新方法提供了对粉末解团聚的新见解,以更好地理解复杂的解团聚行为。