Photo-Acoustics Research Laboratory, Department of Mechanical and Aeronautical Engineering, Clarkson University, Potsdam, NY 13699-5725, USA.
St. John Fisher College, Wegmans School of Pharmacy, Rochester, NY 14618, USA.
Int J Pharm. 2018 May 5;542(1-2):153-163. doi: 10.1016/j.ijpharm.2018.03.018. Epub 2018 Mar 10.
Currently, the compressed tablet and its oral administration is the most popular drug delivery modality in medicine. The accurate porosity and tensile strength characterization of a tablet design is vital for predicting its performance such as disintegration, dissolution, and drug-release efficiency upon administration as well as ensuring its mechanical integrity. In current work, a non-destructive contact ultrasonic approach and an associated testing procedure are presented and employed to quantify and relate the acoustically extracted mechanical properties of pharmaceutical compacts to direct porosity and tensile strength measurements. Based on a comprehensive set of experimental data, it is demonstrated how strongly the acoustic wave propagation is modulated and correlated to the tablet porosity and tensile strength of a compact made using spray-dried lactose and microcrystalline cellulose with varying mixture ratios. The effect of mixing ratio on the porosity and tensile strength on the resulting compacts is quantified and, with the acoustic experimental data, mixing ratio is related to the compact ultrasonic characteristics. The ultrasonic techniques provide a rapid, non-destructive means for evaluating compacts in formulation development and manufacturing. The presented approach and data could find critical applications in continuous tablet manufacturing, its real-time quality monitoring, as well as minimizing batch-to-batch quality variations.
目前，压缩片剂及其口服给药是医学中最流行的药物输送方式。准确的孔隙率和拉伸强度特性描述对于预测片剂的性能至关重要，例如在给药时的崩解、溶解和药物释放效率，以及确保其机械完整性。在目前的工作中，提出并采用了一种非破坏性接触超声方法和相关测试程序，以量化和将声提取的药物压缩机械性能与直接孔隙率和拉伸强度测量相关联。基于一组全面的实验数据，展示了使用喷雾干燥乳糖和微晶纤维素以不同混合比制成的片剂的声传播如何强烈地受到调制和与片剂的孔隙率和拉伸强度相关联。量化了混合比对所得片剂的孔隙率和拉伸强度的影响，并结合声实验数据，将混合比对片剂的超声特性进行了关联。超声技术为配方开发和制造中的片剂评估提供了快速、非破坏性的手段。所提出的方法和数据可以在连续片剂制造、实时质量监测以及最小化批间质量变化方面找到关键应用。
