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测量甲芬那酸粉末在不锈钢表面的附着情况。

Measuring the sticking of mefenamic acid powders on stainless steel surface.

机构信息

Surfaces and Particle Engineering Laboratory (SPEL), Department of Chemical Engineering, Imperial College London, South Kensington Campus, London SW7 2AZ, UK(1).

Bristol-Myers Squibb, Co., One Squibb Drive, New Brunswick, NJ 08902, USA.

出版信息

Int J Pharm. 2015 Dec 30;496(2):407-13. doi: 10.1016/j.ijpharm.2015.09.067. Epub 2015 Oct 9.

Abstract

This study proposes an approach for quantifying the amount of pharmaceutical powder adhering (quality attribute) to the metals surfaces. The effect of surface roughness (detrimental attribute) on the amount of powder sticking to a stainless steel surface for a model pharmaceutical material is also qualitatively determined. Methodology to quantify powder adhesion to surfaces utilises a texture analyser and HPLC. The approach was validated to qualitatively investigate effect of metal surface roughness on adhesion of mefenamic acid. An increase in metal surface roughness resulted in an increase in cohesion. By increasing the average roughness from 289nm to 407nm, a 2.5 fold increase in amount adhering to metal was observed, highlighting the role of surface roughness on adhesion. The simplicity in experimental design with no requirement of specialised equipment and operational ease makes the approach very easy to adopt. Further, ease in interpreting results makes this methodology very attractive.

摘要

本研究提出了一种定量测定药物粉末附着量(质量属性)的方法。还定性地确定了表面粗糙度(有害属性)对模型药物在不锈钢表面上的粉末附着量的影响。用于定量测定表面粉末附着量的方法利用了纹理分析仪和 HPLC。该方法经过验证,可定性研究金属表面粗糙度对甲芬那酸附着的影响。金属表面粗糙度的增加导致内聚力的增加。通过将平均粗糙度从 289nm 增加到 407nm,观察到附着在金属上的量增加了 2.5 倍,这突出了表面粗糙度对附着的作用。该方法的实验设计简单,不需要特殊设备和易于操作,因此非常容易采用。此外,结果易于解释,这使得该方法非常有吸引力。

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