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首页> 外文期刊>Journal of pharmaceutical sciences. >Design and characterization of a new miniaturized rotating disk equipment for in vitro dissolution rate studies.
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Design and characterization of a new miniaturized rotating disk equipment for in vitro dissolution rate studies.

机译：用于体外溶出速率研究的新型小型旋转盘设备的设计和表征。

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摘要

A miniaturized apparatus for the determination of the apparent in vitro dissolution rate has been designed, constructed and characterized. The miniaturized apparatus was based on a low volume dissolution cell and a disk in a rotating magnetic bar. The disk tablet is pressed directly into the bar with a press designed and constructed for this purpose. It requires approximately 5 mg of substance. The disk was positioned eccentrically on the bar with an external flow of medium to increase the rate of solvent flow over the disk surface. Six different drug substances were used. The dissolution media were sodium phosphate buffer, pH 7.0, and ammonium acetate buffer, pH 6.8. All quantifications were made by integrating the dissolution cell with high-performance liquid chromatography (HPLC) using diode-array detection (DAD). The obtained results were compared with data from a conventional rotating disk equipment, where the disk was centrically mounted. The dissolution rates at 100 rpm seemed to be on an average of 2-3 times higher for the miniaturized apparatus (RSD 0.2-56%). The preliminary studies of this prototype indicate that the miniaturized rotating disk is a promising design for the qualitative estimation of dissolution rates of substances, for example during screening in early drug discovery.
机译：已经设计，构造和表征了用于确定表观体外溶出速率的小型仪器。小型化设备基于小体积溶解池和旋转磁棒中的圆盘。使用为此目的而设计和制造的压力机，将磁盘片直接压入杆中。它需要大约5毫克的物质。将盘偏心地放置在带有外部介质流的棒上，以增加溶剂在盘表面上的流动速率。使用了六种不同的原料药。溶解介质为pH 7.0的磷酸钠缓冲液和pH 6.8的乙酸铵缓冲液。通过将溶解池与使用二极管阵列检测（DAD）的高效液相色谱（HPLC）集成在一起进行所有定量。将获得的结果与来自传统旋转磁盘设备的数据进行比较，在传统旋转磁盘设备中，磁盘是在中心安装的。对于小型设备，在100 rpm时的溶解速率似乎平均要高2-3倍（RSD 0.2-56％）。该原型的初步研究表明，微型转盘是一种用于定量评估物质溶解速率的有前途的设计，例如在早期药物发现中的筛选过程中。

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