A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products

被引：0

作者：

Singh, S

Mohan, B

机构：

来源：

INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE | 2003年 / 7卷 / 03期

关键词：

FDC anti-tuberculosis products; poor bioavailability; instability; packaging effects;

D O I：

暂无

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

A pilot stability study was carried out on four fixed-dose combination anti-tuberculosis products at 40degreesC and 75% RH. The strip-packed products were stable, while the blister-packed products showed both physical and chemical changes. The products in unpacked conditions showed severe (similar to60%) decomposition of rifampicin and extensive physical changes. The main decomposition product in the solid state was isonicotinyl hydra-zone of 3-formylrifamycin and isoniazid. It is suggested that attention should be paid to the detection and quantitation of this product in the marketed formulations. The packing material used in the manufacture of FDC products should also be of the highest quality.

引用

页码：298 / 303

页数：6

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