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脉冲激励技术作为一种表征药物片剂弹性性质的工具的适用性:实验与数值研究。

Applicability of impulse excitation technique as a tool to characterize the elastic properties of pharmaceutical tablets: Experimental and numerical study.

机构信息

Univ. Bordeaux, CNRS, Arts et Metiers Institute of Technology, Bordeaux INP, INRAE, I2M Bordeaux, F-33400 Talence, France.

Univ. Bordeaux, CNRS, Arts et Metiers Institute of Technology, Bordeaux INP, INRAE, I2M Bordeaux, F-33400 Talence, France.

出版信息

Int J Pharm. 2020 Nov 30;590:119892. doi: 10.1016/j.ijpharm.2020.119892. Epub 2020 Sep 16.

Abstract

Elastic properties are of particular interest during the development of tablets especially for the definition of the formulation and of the process parameters. Impulse excitation, which is used in several industrial fields to determine elastic properties of materials, is presented in this article as a new fast and relatively cheap technology for the determination of elastic constants of pharmaceutical tablets. This technique is based on the detection of the natural resonance frequencies of solids. It was found in the present work that, for tablets obtained using different products under different compaction pressures, it was possible to detect clearly at least 3 resonance frequencies. Moreover, the shape of the resonance peaks obtained in the spectrum could be a sign of the viscoelastic nature of the tablet. With the two first resonance frequencies, it was possible, under the assumption of isotropy, to calculate Young's modulus and Poisson's ratio for each tablet using the methodology presented in the norm ASTM E1876-01. The values obtained were found independent of the tablet size as expected, and were consistent with those presented in the literature using other methodologies. Moreover, using FEM simulation, it was found that the difference between the experimental value of the third resonance frequency and the value obtained numerically was well correlated with the expected anisotropy of the tablet. Impulse excitation could thus be an interesting methodology to study tablet anisotropy.

摘要

弹性性质在片剂的开发过程中尤其受到关注,特别是在确定配方和工艺参数方面。脉冲激励在多个工业领域中被用于确定材料的弹性性质,本文将其作为一种新的快速且相对廉价的技术,用于确定药物片剂的弹性常数。该技术基于对固体自然共振频率的检测。本工作发现,对于使用不同产品在不同压实压力下获得的片剂,可以清楚地检测到至少 3 个共振频率。此外,在频谱中获得的共振峰的形状可能是片剂粘弹性的标志。对于各片剂,假设各向同性,利用 ASTM E1876-01 标准中提出的方法,仅使用前两个共振频率就可以计算杨氏模量和泊松比。根据预期,所获得的值与片剂尺寸无关,并且与使用其他方法获得的文献中给出的值一致。此外,通过有限元模拟发现,实验获得的第三个共振频率值与数值计算得到的值之间的差异与片剂的预期各向异性很好地相关。因此,脉冲激励可能是研究片剂各向异性的一种有趣方法。

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