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采用有限元方法研究双凸面圆柱形片剂在径载下的拉伸失效。

Investigations into the tensile failure of doubly-convex cylindrical tablets under diametral loading using finite element methodology.

机构信息

Department of Mechanical Engineering, University College London, Torrington Place, London WC1E 7JE, UK.

出版信息

Int J Pharm. 2013 Sep 15;454(1):412-24. doi: 10.1016/j.ijpharm.2013.06.069. Epub 2013 Jul 5.

Abstract

In the literature various solutions exist for the calculation of the diametral compression tensile strength of doubly-convex tablets and each approach is based on experimental data obtained from single materials (gypsum, microcrystalline cellulose) only. The solutions are represented by complex equations and further differ for elastic and elasto-plastic behaviour of the compacts. The aim of this work was to develop a general equation that is applicable independently of deformation behaviour and which is based on simple tablet dimensions such as diameter and total tablet thickness only. With the help of 3D-FEM analysis the tensile failure stress of doubly-convex tables with central cylinder to total tablet thickness ratios W/D between 0.06 and 0.50 and face-curvature ratios D/R between 0.25 and 1.85 were evaluated. Both elastic and elasto-plastic deformation behaviour were considered. The results of 80 individual simulations were combined and showed that the tensile failure stress σt of doubly-convex tablets can be calculated from σt=(2P/πDW)(W/T)=2P/πDT with P being the failure load, D the diameter, W the central cylinder thickness, and T the total thickness of the tablet. This equation converts into the standard Brazilian equation (σt=2P/πDW) when W equals T, i.e. is equally valid for flat cylindrical tablets. In practice, the use of this new equation removes the need for complex measurements of tablet dimensions, because it only requires values for diameter and total tablet thickness. It also allows setting of standards for the mechanical strength of doubly-convex tablets. The new equation holds both for elastic and elasto-plastic deformation behaviour of the tablets under load. It is valid for all combinations of W/D-ratios between 0.06 and 0.50 with D/R-ratios between 0.00 and 1.85 except for W/D=0.50 in combination with D/R-ratios of 1.85 and 1.43 and for W/D-ratios of 0.40 and 0.30 in combination with D/R=1.85. FEM-analysis indicated a tendency to failure by capping or even more complex failure patterns in these exceptional cases. The FEM-results further indicated that in general W/D-ratios between 0.15 and 0.20 are favourable when the overall size and shape of the tablets is modified to give maximum tablet tensile strength. However, the maximum tensile stress of doubly-convex tablets will never exceed that of a flat-face cylindrical tablet of similar W/D-ratio. The lowest tensile stress depends on the W/D-ratio. For the thinnest central cylinder thickness, this minimum stress occurs at D/R=0.50; for W/D-ratios between 0.10 and 0.20 the D/R-ratio for the minimum tensile stress increases to 0.67, and for all other central cylinder thicknesses the minimum tensile stress is found at D/R=1.00.

摘要

在文献中,存在各种用于计算双凸片剂的直径压缩拉伸强度的解决方案,每种方法都基于仅从单一材料(石膏,微晶纤维素)获得的实验数据。这些解决方案由复杂的方程式表示,并进一步因压坯的弹性和弹塑性行为而有所不同。本工作的目的是开发一种通用方程,该方程可独立于变形行为而适用,并且仅基于片剂的简单尺寸,例如直径和总片剂厚度。借助 3D-FEM 分析,评估了中央圆柱与总片剂厚度比 W/D 为 0.06 至 0.50 且面曲率比 D/R 为 0.25 至 1.85 的双凸片剂的拉伸破坏应力。同时考虑了弹性和弹塑性变形行为。80 个单独模拟的结果进行了组合,结果表明,双凸片剂的拉伸破坏应力 σt 可以通过 σt=(2P/πDW)(W/T)=2P/πDT 来计算,其中 P 是破坏载荷,D 是直径,W 是中央圆柱的厚度,T 是片剂的总厚度。当 W 等于 T 时,该方程转换为标准的巴西方程式(σt=2P/πDW),即同样适用于扁平圆柱形片剂。在实践中,使用这种新方程消除了对片剂尺寸进行复杂测量的需要,因为它仅需要直径和总片剂厚度的值。它还允许为双凸片剂的机械强度设置标准。新方程适用于在加载下片剂的弹性和弹塑性变形行为。它适用于 W/D 比在 0.06 至 0.50 之间且 D/R 比在 0.00 至 1.85 之间的所有组合,除了 W/D=0.50 与 D/R 比为 1.85 和 1.43 以及 W/D 比为 0.40 和 0.30 与 D/R=1.85 结合的情况。有限元分析表明,在这些特殊情况下,倾向于出现盖层失效甚至更复杂的失效模式。有限元分析结果还表明,通常当片剂的整体尺寸和形状发生变化以获得最大片剂拉伸强度时,W/D 比在 0.15 至 0.20 之间是有利的。然而,双凸片剂的最大拉伸强度永远不会超过具有相似 W/D 比的平面圆柱形片剂的最大拉伸强度。最低拉伸应力取决于 W/D 比。对于最薄的中央圆柱厚度,最小应力出现在 D/R=0.50;对于 W/D 比在 0.10 至 0.20 之间,最小拉伸应力的 D/R 比增加到 0.67,对于所有其他中央圆柱厚度,最小拉伸应力出现在 D/R=1.00。

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