COMPARATIVE DISSOLUTION BEHAVIOUR OF TEN MARKETED CHLORAMPHENICOL CAPSULES IN INDONESIA

Background: Chloramphenicol capsules are found in several brands with different prices in the market. This study aimed to obtain in-vitro biopharmaceutics quality data from the generic and branded name products. Methods: Ten products were selected, consisted of 3 generics (A, B and C) and 7 branded names (D, E, F, G, H, I and J); F was chosen as an innovator. The dissolution test was performed by using the basket method in medium 0.01 N HCl pH 1.28 ± 0.05; the analysis was done using spectrophotometer UV-Visible at 277.6 nm. The dissolution profiles were analyzed using a kinetic equation and similarity factor. AnX-ray diffraction analysis was done to confirm the results. Results: There were no significant differences in the amount dissolves in 20 minutes between the innovator and other products (p>0.05). Products A, C, H, I and J were similar with the innovator; the f₂ values were 54.82; 50.74; 66.16; 91.34 and 51.35% respectively. Other products (B, D, E, and G) were not similar. The diffractogram showed similar pattern indicating an amorphous form with different peak intensity. Conclusion: All products were by the requirements of the 5^th Indonesian Pharmacopoeia; however, there were differences in dissolution profiles which supports the reason for different efficacy and prices.