Maa Y F, Costantino H R, Nguyen P A, Hsu C C
Genentech, Inc., South San Francisco, CA 94080, USA.
Pharm Dev Technol. 1997 Aug;2(3):213-23. doi: 10.3109/10837459709031441.
The purpose of this research was to investigate the shape and morphology of various spray-dried protein powders as a function of spray-drying conditions and protein formulations. A benchtop spray dryer was used to spray dry three model proteins in formulation with a sugar or a surfactant. Physical characterizations of the powder included morphology (scanning electron microscopy), particle size, residual moisture, and X-ray powder diffraction analyses. A significant change in particle shape from irregular (e.g., "donut") to spherical was observed as the outlet temperature of the dryer was decreased. The drying air outlet temperature was shown to depend on various operating parameters and was found to correlate with the drying rate of atomized droplets in the drying chamber. The morphology of spray-dried protein particles was also affected by formulation. In protein:sugar formulations, spray-dried particles exhibited a smooth surface regardless of the protein-to-lactose ratio, whereas roughness was observed when mannitol was present at > 30% of total solids, due to recrystallization. Protein particles containing trehalose at concentrations > 50% were highly agglomerated. The presence of surfactant resulted in noticeably smoother, more spherical particles. The shape and the morphology of spray-dried powders are affected by spray drying conditions and protein formulation. This study provides information useful for development of dry proteins for fine powder (e.g., aerosol) applications.
本研究的目的是研究各种喷雾干燥蛋白质粉末的形状和形态,作为喷雾干燥条件和蛋白质配方的函数。使用台式喷雾干燥器对三种模型蛋白质与糖或表面活性剂的配方进行喷雾干燥。对粉末的物理特性进行了表征,包括形态(扫描电子显微镜)、粒径、残留水分和X射线粉末衍射分析。随着干燥器出口温度的降低,观察到颗粒形状从不规则(如“甜甜圈”)显著变为球形。结果表明,干燥空气出口温度取决于各种操作参数,并且发现与干燥室内雾化液滴的干燥速率相关。喷雾干燥蛋白质颗粒的形态也受配方影响。在蛋白质:糖配方中,无论蛋白质与乳糖的比例如何,喷雾干燥颗粒都呈现光滑表面,而当甘露醇占总固体的比例>30%时,由于重结晶会观察到粗糙度。浓度>50%的海藻糖的蛋白质颗粒高度团聚。表面活性剂的存在导致颗粒明显更光滑、更呈球形。喷雾干燥粉末的形状和形态受喷雾干燥条件和蛋白质配方的影响。本研究为开发用于细粉(如气雾剂)应用的干燥蛋白质提供了有用信息。