Navaneethan Charu V, Missaghi Shahrzad, Fassihi Reza
Temple University School of Pharmacy, 3307 N Broad St, Philadelphia, PA 19140, USA.
AAPS PharmSciTech. 2005 Oct 19;6(3):E398-404. doi: 10.1208/pt060349.
The objective of this study was to understand the behavior of particulate systems under different conditions of shear dynamics before and after granulation and to investigate the efficiency of powder lubrication. Three drug powders, metronidazole, colloidal bismuth citrate, and tetracycline hydrochloride, were chosen as model drugs representing noncohesive and cohesive powder systems. Each powder was individually granulated with microcrystalline cellulose and 5%PVP as a binder. One portion from each granulation was lubricated with different levels of magnesium stearate for 5 minutes. The powder characterization was performed on the plain powders, nonlubricated and lubricated granules using powder rheometer equipped with a helical blade rotating and moving under experimentally fixed set of parameters. The profiles of interaction during the force-distance measurements indicate that powder compresses, expands, and shears many times in a test cycle. Test profiles also clearly reveal existence of significant differences between cohesive and noncohesive powders. In all cases lubrication normalized the overall interactive nature of the powder by reducing peaks and valleys as observed from the profiles and reduced the frictional effect. The developed methods are easy to perform and will allow formulation scientists to better understand powder behavior and help in predicting potential impact of processing factors on particulate systems.
本研究的目的是了解制粒前后颗粒系统在不同剪切动力学条件下的行为,并研究粉末润滑的效率。选择三种药物粉末,甲硝唑、胶体枸橼酸铋和盐酸四环素,作为代表非粘性和粘性粉末系统的模型药物。每种粉末分别与微晶纤维素和5%聚乙烯吡咯烷酮作为粘合剂进行制粒。每种制粒物的一部分用不同水平的硬脂酸镁润滑5分钟。使用配备有在实验固定参数组下旋转和移动的螺旋叶片的粉末流变仪,对普通粉末、未润滑和润滑颗粒进行粉末表征。力-距离测量过程中的相互作用曲线表明,粉末在一个测试周期内会多次压缩、膨胀和剪切。测试曲线还清楚地揭示了粘性和非粘性粉末之间存在显著差异。在所有情况下,润滑通过减少曲线中观察到的峰谷,使粉末的整体相互作用性质标准化,并降低了摩擦效应。所开发的方法易于实施,将使配方科学家能够更好地理解粉末行为,并有助于预测加工因素对颗粒系统的潜在影响。