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首页> 外文期刊>Journal of pharmaceutical sciences. >Theoretical dissolution model of poly-disperse drug particles in biorelevant media.
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Theoretical dissolution model of poly-disperse drug particles in biorelevant media.

机译：生物相关介质中多分散药物颗粒的理论溶出模型。

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摘要

The purpose of the present study was to construct the theoretical dissolution model of poly-disperse drug particles in biorelevant media containing bile salt/ lecithin aggregates (micelles or vesicles). The effective diffusion coefficient in the biorelevant medium and the particle size distribution of drug particles were simultaneously factored into the Nernst-Brunner equation. The effective diffusion coefficient of a drug in the biorelevant medium was calculated to be smaller than that in the blank buffer, since the diffusion coefficient of a drug bound to the aggregates became similar to that of the aggregates. The particle size distribution of a drug powder was simulated as the sum of mono-disperse fractions covering the particle size range. To verify the modified equation, the dissolution profile of griseofulvin and danazol in a taurocholic acid/egg lecithin (4:1 mixture, taurocholic acid = 0-30 mM) system was investigated. It was clearly demonstrated that both modifications on the Nernst-Brunner equation improved the prediction accuracy. When the effect of the particle size distribution was neglected, the theoretical curve underestimated the observed value at the early phase of dissolution process. When the diffusion coefficient of a free drug was used instead of the effective diffusion coefficient, the theoretical curve overestimated the observed value. The results of the present study suggested that the effect of the particle size distribution and the effective diffusion coefficient should be taken into consideration.
机译：本研究的目的是构建在含有胆盐/卵磷脂聚集体（胶束或囊泡）的生物相关介质中多分散药物颗粒的理论溶出模型。同时将生物相关介质中的有效扩散系数和药物颗粒的粒径分布纳入Nernst-Brunner方程。计算药物在生物相关介质中的有效扩散系数要小于空白缓冲液中的有效扩散系数，这是因为与聚集体结合的药物的扩散系数变得与聚集体的扩散系数相似。将药物粉末的粒径分布模拟为覆盖粒径范围的单分散级分的总和。为了验证修改后的方程，研究了灰黄霉素和达那唑在牛磺胆酸/鸡蛋卵磷脂（4：1混合物，牛磺胆酸= 0-30 mM）系统中的溶出曲线。清楚地表明，对Nernst-Brunner方程的两种修改都提高了预测精度。当忽略粒度分布的影响时，理论曲线低估了溶解过程早期的观测值。当使用游离药物的扩散系数代替有效扩散系数时，理论曲线会高估观测值。本研究结果表明，应考虑粒径分布和有效扩散系数的影响。

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