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Home / The International Journal of Tuberculosis and Lung Disease, Volume 9, Number 11

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

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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: 01 November 2005

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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