Department of Mechanical and Aeronautical Engineering, Photo-Acoustics Research Laboratory, Clarkson University, Potsdam, NY 13699-5725, USA.
Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT 06877, USA.
Int J Pharm. 2022 Jul 25;623:121922. doi: 10.1016/j.ijpharm.2022.121922. Epub 2022 Jun 17.
In compacted materials, elastic anisotropy coupled with residual stresses could play a determining role in the manifestation of various types of defects such as capping and lamination, as it creates shear planes/bands and temporal relaxation. This internal micro-structure leads to time-delayed flaw initiation/formation, crack tip propagation under residual stresses, and ultimately product quality failures. Thus, their accurate characterization and variations are useful for understanding underlying failure mechanisms and to monitor variations in materials, processes and product quality during production prior to onset of failure. The extraction of tablet anisotropic elasticity properties is a challenging task, especially for commercial tablets with complex shapes, as shape often prevents the use of traditional destructive techniques (e.g., diametric compression testers) to produce accurate measurements. This study introduces and applies an ultrasonic approach to extracting the complete transverse isotropic elastic properties of compressed oral solid dosage forms to a commercial tablet product. A complete set of waveforms and the constitutive matrix for the compacted materials are reported. In addition, a perturbation analysis is carried out to analytically relate propagation speeds in various directions to the elastic coefficients. The proposed characterization approach is non-destructive, rapid, easy, and reliable in evaluating tablet anisotropy.
在压实材料中,弹性各向异性与残余应力结合可能会在各种类型的缺陷(如盖层和分层)的表现中起决定性作用,因为它会产生剪切面/带和时间松弛。这种内部微观结构导致缺陷延迟萌生/形成、残余应力下的裂纹尖端扩展,最终导致产品质量失效。因此,准确描述和监测其变化有助于理解潜在的失效机制,并在失效发生之前监测生产过程中材料、工艺和产品质量的变化。提取片剂各向异性弹性特性是一项具有挑战性的任务,特别是对于具有复杂形状的商业片剂,因为形状通常会阻止使用传统的破坏性技术(例如,直径压缩测试器)来进行准确的测量。本研究引入并应用了一种超声方法来提取压缩口服固体制剂的完全横向各向同性弹性特性,应用于一种商业片剂产品。报告了一组完整的波形和压实材料的本构矩阵。此外,还进行了摄动分析,以解析地将各个方向的传播速度与弹性系数联系起来。所提出的表征方法是非破坏性的、快速的、简便的,并且可以可靠地评估片剂各向异性。