Picker-Freyer Katharina Maria
Martin-Luther-University Halle-Wittenberg, Institute of Pharmaceutics and Biopharmaceutics, Wolfgang-Langenbeck-Str. 4, 06120 Halle/Saale, Germany.
J Pharm Sci. 2007 May;96(5):1408-17. doi: 10.1002/jps.20946.
The aim of the study was to evaluate the parameters d, e, and omega for their significance in compression data analysis. Materials with predominantly different compression properties were used and tableting data were obtained with an instrumented eccentric and rotary tableting machine. The parameters time plasticity (d), pressure plasticity (e), and the twisting angle (omega), an indicator of fast elastic decompression, were derived by 3-D modeling. The Peak-Offset-Time, the pressure-time function parameters, the Heckel slope, normalized compaction (E2(norm)) and elastic energy (E3(norm)), and fast elastic recovery (FER), which are well known tableting parameters, were calculated from the tableting data. The plastic microhardness of the tablets was determined from using microindentation. The results revealed that d is influenced by speed, e correlates with microhardness, and omega correlates with the Elastic modulus (E). Thus, for all three 3-D model parameters an experimental basis is given. The validation showed that d correlates with the Peak-Offset-Time and the pressure-time function parameters, e correlates with the Heckel slope and E2(norm), and omega correlates with E3(norm) and FER of the tablets. The significance of the three parameters is fully given. It is no longer necessary to use two separate methods to differentiate between time- and pressure-dependent deformations.
本研究的目的是评估参数d、e和ω在压缩数据分析中的重要性。使用了具有主要不同压缩特性的材料，并通过一台装有仪器的偏心旋转压片机获得压片数据。通过三维建模得出时间可塑性（d）、压力可塑性（e）以及作为快速弹性解压指标的扭转角（ω）等参数。从压片数据中计算出峰偏移时间、压力-时间函数参数、赫克尔斜率、归一化压实度（E2(norm)）和弹性能（E3(norm)）以及快速弹性恢复（FER）等众所周知的压片参数。通过微压痕法测定片剂的塑性显微硬度。结果表明，d受速度影响，e与显微硬度相关，ω与弹性模量（E）相关。因此，为所有这三个三维模型参数提供了实验依据。验证表明，d与峰偏移时间和压力-时间函数参数相关，e与赫克尔斜率和E2(norm)相关，ω与片剂的E3(norm)和FER相关。这三个参数的重要性得到了充分体现。不再需要使用两种单独的方法来区分时间依赖性和压力依赖性变形。
