Simulation and evaluation of tablet-coating burst based on finite element method

Simulation and evaluation of tablet-coating burst based on finite element method
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基于有限元法的片剂包衣破裂模拟与评价

DOI:
10.3109/03639045.2015.1137304
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发表时间:
2016-01
影响因子:
3.4
通讯作者:
Hai-Ning Yu
Hai-Ning Yu
中科院分区:
医学4区
文献类型:
--
作者:
Yan Yang;Juan Li;Kong-Song Miao;Wei-Guang Shan;Lan Tang;Hai-Ning Yu

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摘要 本研究的目的是模拟和评估包衣片剂的破裂行为。利用ANSYS软件建立了片剂包衣的三维有限元模型。采用自制装置测量岩心膨胀压力,并将其施加于模型内表面。使用质构分析仪测定聚合物薄膜的机械性能,并将其用作模型的材料性能。所得到的有限元模型通过实验数据进行了验证。经验证的模型用于评估影响爆裂行为的因素并预测涂层爆裂行为。涂层破裂和失效位置的模拟结果与实验数据高度吻合。研究发现,内部膨胀压力、内角半径和角部厚度是控制应力分布和爆裂行为的三个主要因素。根据内压与涂层最大主应力之间的线性关系,计算涂层的爆破压力并用于预测爆破行为。这项研究表明,包衣片剂的爆裂行为可以通过有限元方法进行模拟和评估。
Abstract The objective of this study was to simulate and evaluate the burst behavior of coated tablets. Three-dimensional finite element models of tablet-coating were established using software ANSYS. Swelling pressure of cores was measured by a self-made device and applied at the internal surface of the models. Mechanical properties of the polymer film were determined using a texture analyzer and applied as material properties of the models. The resulted finite element models were validated by experimental data. The validated models were used to assess the factors those influenced burst behavior and predict the coating burst behavior. The simulation results of coating burst and failure location were strongly matched with the experimental data. It was found that internal swelling pressure, inside corner radius and corner thickness were three main factors controlling the stress distribution and burst behavior. Based on the linear relationship between the internal pressure and the maximum principle stress on coating, burst pressure of coatings was calculated and used to predict the burst behavior. This study demonstrated that burst behavior of coated tablets could be simulated and evaluated by finite element method.
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