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纯羟丙基甲基纤维素片剂溶胀与侵蚀行为的分析与建模

Analysis and modeling of swelling and erosion behavior for pure HPMC tablet.

作者信息

Chirico Serafina, Dalmoro Annalisa, Lamberti Gaetano, Russo Giuseppina, Titomanlio Giuseppe

机构信息

Department of Chemical and Food Engineering, University of Salerno, Fisciano (SA), Italy.

出版信息

J Control Release. 2007 Sep 26;122(2):181-8. doi: 10.1016/j.jconrel.2007.07.001. Epub 2007 Aug 15.

Abstract

This work is focused on the transport phenomena which take place during immersion in water of pure hydroxypropylmethylcellulose tablets. The water uptake, the swelling and the erosion during immersion were investigated in drug-free systems, as a preliminary task before to undertake the study of drug-loaded ones. The tablets, obtained by powder compression, were confined between glass slabs to allow water uptake only by lateral surface and then immersed in distilled water at 37 degrees C, with simultaneous video-recording. By image analysis the normalized light intensity profiles were obtained and taken as a measure of the water mass fraction. The time evolutions of the total tablet mass, of the water mass and of the erosion radius were measured, too. Thus a novel method to measure polymer and water masses during hydration was pointed out. Then, a model consisting in the transient mass balance, accounting for water diffusion, diffusivity change due to hydration, swelling and erosion, was found able to reproduce all experimental data. Even if the model was already used in literature, the novelty of our approach is to compare model predictions with a complete set of experimental data, confirming that the main phenomena were correctly identified and described.

摘要

这项工作聚焦于纯羟丙基甲基纤维素片剂浸入水中时发生的传输现象。作为开展载药片剂研究之前的一项初步任务,在无药体系中研究了浸入过程中的吸水、溶胀和侵蚀情况。通过粉末压制获得的片剂被夹在玻璃板之间,以使水仅通过侧面吸收,然后将其浸入37摄氏度的蒸馏水中,并同时进行视频记录。通过图像分析获得归一化光强分布,并将其作为水质量分数的度量。还测量了片剂总质量、水质量和侵蚀半径随时间的变化。由此指出了一种在水合过程中测量聚合物和水质量的新方法。然后,发现一个由瞬态质量平衡组成的模型,该模型考虑了水扩散、水合作用引起的扩散系数变化、溶胀和侵蚀,能够重现所有实验数据。即使该模型已在文献中使用,我们方法的新颖之处在于将模型预测与一整套实验数据进行比较,证实了主要现象已被正确识别和描述。

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