Merck & Co., Inc., Sterile and Specialty Products, Rahway, New Jersey, USA.
Merck & Co., Inc., Small Molecule Analytical Research and Development, Rahway, New Jersey, USA.
AAPS PharmSciTech. 2024 Feb 23;25(3):45. doi: 10.1208/s12249-024-02743-8.
In this study, dry dispersion laser diffraction was used to study the dispersibility of spheronized agglomerate formulations and identify geometric particle size metrics that correlated well with aerodynamic particle size distribution (APSD). Eleven unique batches of agglomerates were prepared for both laser diffraction and cascade impaction testing. Correlations between the particle size distribution (PSD) and aerodynamic particle size distribution (APSD) metrics for the eleven agglomerate batches were determined in a semi-empirical manner. The strongest correlation between APSD and PSD was observed between the impactor-sized mass (%ISM) and the cumulative PSD fraction <14.5 µm. The strongest correlation with fine particle fraction (FPF) was observed with the cumulative PSD fraction <0.99 micron (R-squared = 0.974). In contrast to the other APSD metrics, good correlations were not found between the mass median aerodynamic diameter (MMAD) and the cumulative PSD fractions. Overall, the implementation of laser diffraction as a surrogate for cascade impaction has the potential to streamline product development. Laser diffraction measurements offer savings in labor and turnaround time compared to cascade impaction.
在这项研究中，干分散激光衍射被用于研究球形团聚体配方的分散性，并确定与空气动力学粒径分布（APSD）相关性良好的几何粒径指标。为激光衍射和级联撞击测试制备了十一个独特的团聚体批次。以半经验的方式确定了十一个团聚体批次的粒径分布（PSD）和空气动力学粒径分布（APSD）指标之间的相关性。在 APSD 和 PSD 之间观察到最强的相关性是在冲击器大小的质量（%ISM）和累积 PSD 分数<14.5 µm 之间。与细颗粒分数（FPF）的最强相关性是在累积 PSD 分数<0.99 微米（R-squared = 0.974）处观察到的。与其他 APSD 指标相反，在质量中值空气动力学直径（MMAD）和累积 PSD 分数之间未发现良好的相关性。总体而言，将激光衍射作为级联撞击的替代方法具有简化产品开发的潜力。与级联撞击相比，激光衍射测量在劳动力和周转时间方面具有节省成本的优势。
