Quality control of anti-tuberculosis FDC formulations in the global market: part II-accelerated stability studies.
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 degrees 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 nonpharmacopeial 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.
Ashokraj
Y
Y
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India.
Kohli
G
G
Kaul
C L
CL
Panchagnula
R
R
D000904:Antibiotics, Antitubercular / Q000592:standards*; D004338:Drug Combinations; D004355:Drug Stability; D011786:Quality Control; D012293:Rifampin / Q000592:standards*; D013997:Time Factors
D000904:Antibiotics, Antitubercular; D004338:Drug Combinations; D012293:Rifampin