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压片机冲头中格列本脲片剂黏附故障的葛兰素制剂方法。

Galenic approaches in troubleshooting of glibenclamide tablet adhesion in compression machine punches.

机构信息

Farmanguinhos (FIOCRUZ), Av. Comandante Guaranys 447, 22775-903 Rio de Janeiro, RJ, Brazil.

University of Caxias do Sul, R. Francisco Getúlio Vargas 1130, 95070-560 Caxias do Sul, RS, Brazil.

出版信息

Saudi Pharm J. 2014 Nov;22(5):445-53. doi: 10.1016/j.jsps.2013.08.002. Epub 2013 Sep 11.

Abstract

This study aimed to examine the adhesion of glibenclamide 5 mg tablets to the tools of compression machines. This problem is not commonly reported in the literature, since it is considered as tacit knowledge. The starting point was the implementation of three technical alternatives: changing the parameters of compression, evaluating the humidity of the powder blend and the manufacturer of the lubricant magnesium stearate. The adhesion was directly related to the characteristics of magnesium stearate from different manufacturers, and the feasibility of evaluating powder flow characteristics by different techniques that are not routinely followed in various pharmaceutical companies. In vitro dissolution tests showed that the magnesium stearate manufacturer can influence on the dissolution profile of glibenclamide tablets. This study presented various aspects of tablet adhesion to compression machine punches. Troubleshooting approaches can be, most of times, conducted based on previous experience, or an experimental research needs to be implemented in order to have confident results.

摘要

本研究旨在研究 5mg 格列本脲片剂对压片机工具的黏附情况。这个问题在文献中并不常见报道,因为它被认为是默知识。本研究从实施三个技术方案开始:改变压缩参数、评估粉末混合物的湿度和硬脂酸镁润滑剂的制造商。黏附性与不同制造商的硬脂酸镁特性直接相关,并且可以评估不同技术的粉末流动特性,而这些技术在不同的制药公司中并不常规进行。体外溶出度试验表明,硬脂酸镁制造商可能会影响格列本脲片剂的溶出度曲线。本研究介绍了片剂对压片机冲头黏附的各个方面。故障排除方法通常可以基于以往的经验进行,或者需要进行实验研究以获得可靠的结果。

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