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Free Content Proposed minimum registration requirements for fixed-dose combination anti-tuberculosis drugs

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Registration requirements for combined pharmaceutical preparations have been published before, but not specifically for fixed-dose combination (FDC) anti-tuberculosis preparations. With tuberculosis being a high priority disease world-wide and concerns being raised over sub-standard FDC anti-tuberculosis preparations being marketed on a wide scale, specific guidelines for industry seem to be indicated. This is predominantly necessitated by the fact that rifampicin bioavailability can be adversely affected when put in combination with isoniazid and pyrazinamide, and by the need for standardisation of the formulations to only a few essential combinations in order to better control quality. This paper proposes certain minimum requirements to be met when standardising dose in the combinations and when ensuring bioavailability of the preparations. Nine rifampicin-containing combinations are listed as essential. Furthermore, bioavailability testing of the rifampicin component only by a restricted assay protocol of six sample times over 8 hours is advocated, whilst in vitro procedures for other actives in the combination would suffice for registration purposes.

Keywords: bioavailability; fixed-dose combinations; rifampicin; tuberculosis

Document Type: Regular Paper

Affiliations: National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa

Publication date: 1999-11-01

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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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