AN INVESTIGATION INTO THE RAFT-FORMING PROPERTIES OF TOPAAL WHIP, A NOVEL ANTIREFLUX AGENT, IN HEALTHY-VOLUNTEERS

This study was designed as a balanced unblind two-way crossover design comparing the gastric distribution and residence time of a novel anti -reflux agent, Topaal Whip (3 g - Pierre Fabre, France) to a standard anti-reflux agent, Liquid Gaviscon 10 ml - SmithKline Beecham, France) . The formulations were radiolabelled with indium 113m and the gastric residence was measured in 6 healthy volunteers using gamma scintigrap hy. Each formulation was given thirty minutes after a technetium-99m l abelled meal. Both the Liquid Gaviscon and Topaal Whip demonstrated ra ft formation, i.e. floatation on the gastric contents. The time for ha lf the Topaal whip to empty from the stomach (T50) was 2.71 +/- 0.29 h (mean +/- SEM) and for Liquid Gaviscon was 2.01 +/- 0.19 (p > 0.01). In comparison, the T50 for the meal was 1.57 +/- 0.2 h for both treatm ent arms of the study. The area under the emptying-tine curve also dem onstrated that Topaal Whip was retained in rite stomach for a signific antly longer overall period than Gaviscon (244.37 +/- 14.63 %min versu s 211.05 +/- 16.55 %min respectively (p < 0.03). These data indicate t hat Topaal Whip compares favourably to Gaviscon in terms of gastric re sidence, thus it has the potential to be a successful anti-reflux agen t.