Quality control of anti-tuberculosis FDC formulations in the global market: Part II – accelerated stability studies
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.
Document Type: Regular Paper
Affiliations: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India
Publication date: November 1, 2005
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.
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