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

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A pilot stability study was carried out on four fixed-dose combination anti-tuberculosis products at 40°C 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 (∼60%) decomposition of rifampicin and extensive physical changes. The main decomposition product in the solid state was isonicotinyl hydrazone 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.

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

Document Type: Short Communication

Affiliations: Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India

Publication date: March 1, 2003

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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