Enhancement of dissolution and bioavailability of fenofibrate by Solid Dispersion with sodium citrate, HPMC and sugar derivatives

In this study, a significant effect of sodium citrate increasing fenofibrate dissolution has been demonstrated. This effect was dependent on the polymer: drug mixing weight ratio, the sodium citrate type and the method used to disperse the drug with in the polymer. The greater the sodium citrate content the higher the drug dissolution was, up to a maximum corresponding to a polymer: drug ratio of 6:1. Significant differences within the various tested polymers were observed. The various sodium citrate: fenofibrate solid mixtures were ordered, according to the efficiency of improving the drug dissolution, as follows: solid dispersion\kneaded mixture\solvent evaporation. The drug dissolution enhancement was attributed to the decreased drug crystallinity and size and polymer wetting effect. Solvent evaporation of sodium citrate along with fenofibrate in a 6:1 ratio, which leads to solid mixtures exhibiting a significantly improved dissolution profile without requiring the addition of organic solvents or high temperatures for its preparation, appears to be the more simple and convenient method.