Skip to main content

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

Download Article:
 Download
(PDF 508.99609375 kb)
 
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.
No References
No Citations
No Supplementary Data
No Data/Media
No Metrics

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: 2005-11-01

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

  • Editorial Board
  • Information for Authors
  • Subscribe to this Title
  • International Journal of Tuberculosis and Lung Disease
  • Public Health Action
  • Ingenta Connect is not responsible for the content or availability of external websites
  • Access Key
  • Free content
  • Partial Free content
  • New content
  • Open access content
  • Partial Open access content
  • Subscribed content
  • Partial Subscribed content
  • Free trial content
Cookie Policy
X
Cookie Policy
Ingenta Connect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more