The in-vitro porcine adhesion model is not predictive of the esophageal transit of risedronate tablets in humans.
Mucosal damage due to esophageal adhesion of pharmaceuticals is a continued concern to both health care providers and drug manufacturers. As a result of this concern, dosage forms are now being designed to exhibit minimal esophageal adhesion. Previous researchers have used an in-vitro porcine esophageal model to determine the propensity for formulations to adhere to the esophagus as an alternative to human scintigraphy studies. This study used a porcine esophageal adhesion model similar to that used previously to determine the adhesiveness of placebo bisphosphonate formulations. Results are analogous to those obtained by previous researchers, with film-coated tablets showing greater adhesiveness than uncoated tablets. These same tablet formulations were also evaluated previously by a human scintigraphy study, and the results were exactly opposite of those obtained using the in-vitro porcine model. In the human scintigraphy study, the film-coated placebo risedronate tablet had a faster transit time than an uncoated round placebo tablet. In conclusion, the in-vitro porcine esophageal model is not predictive of esophageal transit in man and gamma scintigraphy is the preferred method to evaluate esophageal transit.
McCargar
L
L
University of Cincinnati, College of Applied Science, 2220 Victory Parkway, Cincinnati, OH 45206-2839, USA.
Crail
D
D
Dansereau
R
R
Myers
W
W
Lane
M
M
D000818:Animals; D002121:Calcium Channel Blockers; D002448:Cell Adhesion; D002626:Chemistry, Pharmaceutical; D004947:Esophagus; D012968:Etidronic Acid / Q000031:analogs & derivatives; D006801:Humans; D008954:Models, Biological; D011237:Predictive Value of Tests; D000068296:Risedronic Acid; D013552:Swine; D013607:Tablets
D002121:Calcium Channel Blockers; D013607:Tablets; D000068296:Risedronic Acid; D012968:Etidronic Acid