Graduate School of Pharmaceutical Sciences, Mylan School of Pharmacy, Duquesne University, 600 Forbes Avenue, Pittsburgh, PA, 15282, USA.
Int J Pharm. 2013 Feb 14;442(1-2):13-9. doi: 10.1016/j.ijpharm.2012.09.006. Epub 2012 Sep 7.
Understanding how a material's response to stress changes as the stress is applied at different rates is important in predicting performance of pharmaceutical powders during tablet compression. Widely used methods for determining strain rate sensitivity (SRS) are empirically based and can often provide inconsistent or misleading results. Indentation creep data, collected during hardness tests on compacts formed from several common tableting excipients, were used to predict each material's relative sensitivity to changes in strain rate. Linear relationships between Ln(indentation hardness) and Ln(strain rate) were observed for all materials tested. The slope values taken from these relationships were compared to traditional strain rate sensitivity estimates based on in-die Heckel analysis. Overall, the results from the two methods were quite similar, but several advantages were evident in the creep data. The most notable advantage was the ability to characterize strain rate sensitivity derived from plastic behavior with little influence of elastic deformation. For example, two grades of corn starch had very similar creep behavior, but their yield pressures were affected very differently when the compaction rate was increased. This inconsistency was related to the difference in the viscoelastic recovery exhibited by these two materials. This new method promises to allow a better understanding of strain rate effects observed during tablet manufacturing.
了解材料在不同应变速率下对应力的响应如何变化,对于预测药物粉末在片剂压缩过程中的性能非常重要。广泛使用的确定应变速率敏感性(SRS)的方法是经验性的,并且经常会提供不一致或误导性的结果。在对由几种常见压片赋形剂制成的片剂进行硬度测试时收集的压痕蠕变数据,用于预测每种材料对应变速率变化的相对敏感性。对所有测试材料均观察到 Ln(压痕硬度)与 Ln(应变速率)之间的线性关系。从这些关系中得出的斜率值与基于模内 Heckel 分析的传统应变速率敏感性估计值进行了比较。总体而言,两种方法的结果非常相似,但蠕变数据具有明显的优势。最显著的优点是能够从塑性行为中得出应变率敏感性的特征,而不受弹性变形的影响。例如,两种玉米淀粉的蠕变行为非常相似,但当压实速率增加时,它们的屈服压力受到的影响却非常不同。这种不一致性与这两种材料表现出的粘弹性恢复差异有关。这种新方法有望更好地理解片剂制造过程中观察到的应变速率效应。