Free Content Quality control of anti-tuberculosis FDC formulations in the global market: Part II – accelerated stability studies

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Abstract:

OBJECTIVE: To determine the quality and performance of rifampicin (RMP) containing fixed-dose combination (FDC) formulations of anti-tuberculosis drugs sourced from the international market with respect to physical, chemical and dissolution properties after storage at accelerated stability conditions (40°C/75% relative humidity) and to identify appropriate storage specifications.

METHODS: Formulations across different companies and combinations were subjected to 6-month accelerated stability testing in packaging conditions recommended by the manufacturer. Various pharmacopeial and non-pharmacopeial tests for tablets were performed for 3- and 6-month samples.

RESULTS: All the formulations were found to be stable, where extent of dissolution was within ±10% of that of the initial value, and all formulations passed the pharmacopeial limits for assay and content uniformity of 90–110% and ±15% of average drug content, respectively.

CONCLUSIONS: Good quality RMP-containing FDCs that remain stable after 6-month accelerated stability testing are available in the marketplace.

Keywords: accelerated stability test; dissolution; fixed-dose combination; rifampicin; tuberculosis

Document Type: Regular Paper

Affiliations: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

Publication date: November 1, 2005

More about this publication?
  • 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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