Comparative evaluation of the bio-efficacy of sucralfate products in laboratory animals

ABSTRACT

The present work introduced an experimental biological approach for comparative assessment of bioequivalency of sucralfate products. The therapeutic effect of sucralfate depends on its ability to form an adherent and protective layer at the site of ulceration. Two complementary experiments were utilized Evaluation of healing of neurogenically produced gastric ulcers in rats, and estimation of aluminum in the sucralfate protective layer at the linings of the gastrointestinal tract in rabbits suffering from mechanically produced gastric ulcers. Sucralfate was administered twice daily for seven days post-ulcer indication. The dose for rats was 285 mg/10 ml water/kg. The dose for rabbits was 0.5 g [0.5 tablet] per animal. Two commercially available products were compared. The applied approach was found useful in assessment of bioequivalence of sucralfate products. A major advantage was the utilization of therapeutically relevant pharmacodynamic quantifiable measures by use of laboratory animals