Department of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland.
Department of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland; School of Pharmacy, University College Cork, Ireland.
Int J Pharm. 2020 Apr 30;580:119216. doi: 10.1016/j.ijpharm.2020.119216. Epub 2020 Mar 9.
This research aims to address a gap in our understanding of the mechanisms by which pharmaceutical tablets achieve highly reproducible and predictable drug release. The present industrial and regulatory practice is centred around tablet dissolution, i.e. what follows disintegration, yet the vast majority of problems that are found in formulation dissolution testing can be traced back to the erratic disintegration behaviour of the medicinal product. It is only due to the distinct lack of quantitative measurement techniques for disintegration analysis that this situation arises. Current methods involve costly, and time-consuming test equipment, resulting in a need for more simple, green and efficient methods which have the potential to enable rapid development and to accelerate routine solid drug formulation dissolution and disintegration testing. In this study, we present a novel approach to track several sequential tablet dissolution processes, including coating erosion, disintegration, deaggregation and dissolution using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS). BARDS, in combination with minimal usage of UV spectroscopy, can effectively track these processes. The data also show that a solid oral dose formulation has an intrinsic acoustic signature which is specific to the method of manufacture and excipient composition.
本研究旨在解决我们对药物片剂实现高度可重复和可预测的药物释放机制的理解不足的问题。目前的工业和监管实践集中在片剂溶解上，即崩解之后的过程，然而，在配方溶解测试中发现的绝大多数问题都可以追溯到药物崩解行为的不稳定。之所以会出现这种情况，仅仅是因为缺乏崩解分析的定量测量技术。目前的方法涉及昂贵且耗时的测试设备，因此需要更简单、绿色和高效的方法，这些方法有可能实现快速开发，并加速常规固体药物配方的溶解和崩解测试。在这项研究中，我们提出了一种新的方法来跟踪几个连续的片剂溶解过程，包括使用宽带声学共振溶解光谱（BARDS）跟踪涂层侵蚀、崩解、解聚和溶解。BARDS 与最小量的紫外光谱学相结合，可以有效地跟踪这些过程。数据还表明，一种口服固体制剂具有内在的声学特征，该特征特定于制造方法和赋形剂组成。
