INVITRO AND INVIVO EVALUATIONS OF A TABLETED ANTACID AND SUCRALFATE, A NEW ANTI-ULCER AGENT

Abstract

Sucralfate is a nonsystemic drug used in the therapy of peptic ulcer disease. It is an aluminum salt of a sulfated disaccharide which adheres to ulcerated sites and forms a cytoprotective barrier to acid peptic digestion. Sucralfate was studied to determine whether it had antiacid activity in humans. The validity of the in vitro antiacid qualifying test was investigated by comparing its results for tableted products with those of in vivo studies. In the in vitro antiacid qualifying test Maalox # 1 (4 tablets) passed and sucralfate (1 g) failed. These findings were consistent with the results of in vivo tests utilizing a telemetric device, the Heidelberg capsule and tube aspirations. Sucralfate does not possess antiacid properties. The results of the standard in vitro antiacid qualifying test correlated well with those of in vitro studies.