In silico tools which predict the dissolution of pharmaceutical dosage forms using virtual matrices can be validated with virtual matrices based on X-ray micro-computed tomography images of real pharmaceutical formulations. Final processed images of 3 different tablet batches were used to check the performance of the in silico tool F-CAD. The goal of this work was to prove the performance of the software by comparing the predicted dissolution profiles to the experimental ones and to check the feasibility and application of the validation concept for in silico tools. Both virtual matrices based on X-ray micro-computed tomography images and designed by the software itself were used. The resulting dissolution curves were compared regarding their similarity to the experimental curve. The kinetics were analysed with the Higuchi and Korsmeyers–Peppas plot. The whole validation concept as such was feasible and worked well. It was possible to identify prediction errors of the software F-CAD and issues with the virtual tablets designed within the software.

中文翻译：

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基于平板电脑 X 射线计算机断层扫描图像的计算机工具新验证方法以及一个工具的性能分析


使用虚拟矩阵预测药物剂型溶出度的计算机模拟工具可以通过基于真实药物制剂的 X 射线微计算机断层扫描图像的虚拟矩阵进行验证。使用 3 个不同批次片剂的最终处理图像来检查计算机工具 F-CAD 的性能。这项工作的目标是通过将预测的溶出曲线与实验曲线进行比较来证明软件的性能，并检查计算机工具验证概念的可行性和应用。使用了基于X射线微计算机断层扫描图像并由软件本身设计的虚拟矩阵。比较所得溶出曲线与实验曲线的相似性。使用 Higuchi 和 Korsmeyers-Peppas 图分析动力学。整个验证概念本身是可行的并且运作良好。可以识别软件 F-CAD 的预测错误以及软件中设计的虚拟平板电脑的问题。