Microstructure-based mathematical modelling and spectroscopic imaging of tablet dissolution

Microstructure-based mathematical modelling and spectroscopic imaging of tablet dissolution
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DOI:
10.1016/j.compchemeng.2010.07.008
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发表时间:
2011-07
期刊:
Comput. Chem. Eng.
影响因子:
--
通讯作者:
J. Kimber;S. Kazarian;F. Štěpánek
J. Kimber;S. Kazarian;F. Štěpánek
中科院分区:
其他
文献类型:
--
作者:
J. Kimber;S. Kazarian;F. Štěpánek

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开发了一种计算机模型,其目的是模拟具有非溶胀赋形剂的药物片剂的溶出。使用傅里叶变换红外(FTIR)光谱成像和紫外-可见光谱法验证了该模型,该模型允许明确描述片剂的非均匀微观结构。使用二元片剂模型进行了两项参数研究。一个研究了粒度和片剂组成对组分释放时间的影响,另一个研究了改变一种组分的扩散性和溶解性对两种组分释放时间的影响。在实验中使用含有聚乙二醇(PEG)4000和烟酰胺的片剂。纯组分的物理性质从文献以及使用含有100%和10%(w/w)烟酰胺的片剂的实验中获得。然后使用该模型预测含有40%(w/w)烟酰胺的片剂的溶出度,其与实验相匹配,均方误差为0.08%。
A computer model was developed with the objective of modelling pharmaceutical tablet dissolution with non-swelling excipients. The model, which allows the explicit description of the tablets heterogeneous microstructure, was verified using Fourier Transform Infrared (FTIR) spectroscopic imaging and UV–visible spectroscopy. Two parametric studies were conducted using the model for binary tablets. One investigated the effect of particle size and tablet composition on component release times and the other studied the effect of changing the diffusivity and solubility of one component on the release times of both. Tablets containing Polyethylene Glycol (PEG) 4000 and nicotinamide were used in the experiments. Physical properties of pure components were obtained from literature and also experiments using tablets containing 100% and 10% (w/w) nicotinamide. The model was then used to predict the dissolution of a tablet containing 40% (w/w) nicotinamide which matched the experiment with a mean squared error of 0.08%.