Design and Biopharmaceutical Evaluation of Nitrofurantoin-Loaded Eudragit RS100 Micropellets

Abstract

Nitrofurantoin, a synthetic bactericidal drug, was encapsulated with Eudragit RS 100 polymer by a coacervation phase separation technique using variable proportions of polyisobutylene (0% to 3%) as a protective colloid. The micropellets were evaluated by scanning electron microscopy (SEM), particle size distribution, wall thickness, and loss of wall polymer were determined. The in vitro release experiments were carried out over the entire pH range of the gastrointestinal tract, the data obtained from the dissolution profiles were compared in the light of different kinetic models, and the regression coefficients were compared. The in vivo studies were performed on female human volunteers. A linear correlation was obtained from in vitro–in vivo studies.