Comparisons of physical properties and rates of rifampicin dissolution in Fixed Dose Combination (2FDC) tablet against rifampicin tablet

Abstract

Background: The World Health Organization (WHO) has recommended using fixed dose combination (FDC) for tuberculosis treatments as it can improve patient compliance and prevent drug resistance. A combination of rifampicin and isoniazid can cause reductions in concentration of each drug because the rifampicin is labile and can not be mixed with all three other TB drugs Objective: This study is aimed to understand effects of the combination of both physical properties and dissolutions of rifampin. Methods: This laboratory study observed rifampicin tablets and combination tablets of rifampicin and isoniazid (2 FDC) by testing physical properties of the tablets and dissolution tests. Friability test was conducted by using friability tester, hardness test was by hardness tester, disintegration test was by disintegration tester and dissolution test was by dissolution tester type 1 (basket). Its data were analysed by Mann Whitney test. The data had value if p0.05 ), while there were significant difference of fragile test result and disintegration time 0.015(p<0.05). Conclusion: The combination of rifampicin and isoniazid in tablet 2 Fixed Dose Combination (2 FDC) had no effects on the dissolution rates of rifampicin, but they had effects on some parameters of physical property test of the tablets.

Keywords

• fixed dose combination (fdc), rifampicin, physical properties test, type 1 dissolution test