Quality problems of anti-tuberculosis Fixed-dose Combinations (FDCS) A way forward.
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Date
2006-10
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Abstract
Fixed dose combinations (FDCs) of anti-tuberculosis drugs (Rifampicin, Isoniazid, Pyrazinamide and
Ethambutol hydrochloride) have several advantages over loose combinations of these drugs. Hence, the use of
FDCs in the short course chemotherapy of tuberculosis is being promoted internationally. However, these products
are associated with quality problems such as loss of bio-availability of Rifampicin and instability of the drugs in the
combination. Recent research in Indian laboratories has helped in identification of the major reasons behind these
problems, which suggest that an entirely different approach is required to that currently being recommended by the
world bodies. The purpose of this article is to briefly discuss the twin quality problems and to highlight the potential
forward ways.
Description
Keywords
Anti-tuberculosis FDCs, Bio-availability
Citation
Singh Saranjit, Bhutani Hemant, Mariappan T T. Quality problems of anti-tuberculosis Fixed-dose Combinations (FDCS) A way forward. Indian Journal of Tuberculosis. 2006 Oct; 53(4): 201-205.