The use of scintigraphy to demonstrate the rapid esophageal transit of theoval film-coated placebo risedronate tablet compared to a round uncoated placebo tablet when administered with minimal volumes of water

As our population ages, and the consumption of pharmaceutical products rise s, the incidence of solid oral dosage forms lodging in the esophagus is lik ely to increase and may be formulation dependent. The aim of this study was to compare the esophageal transit of the commercial film-coated risedronat e tablet and a round uncoated tablet resembling the alendronate 10 mg table t which is reported to cause esophagitis if ingested with little to no wate r. Water volumes of 30 ml and 50 ml were selected as these volumes can dete ct formulations prone to esophageal adhesion and a habits and practice stud y showed that these volumes are within the range preferred by women (7-385 ml). A total of 28 healthy postmenopausal women completed the four-way cros sover scintigraphy study. For both volumes of water, the film-coated placeb o risedronate tablet had a statistically significant faster esophageal tran sit time than the uncoated placebo tablet (P = 0.002 for 30 ml water and P < 0.001 for 50 ml water). Among those taking the round, flat, uncoated tabl et, five subjects had esophageal stasis (transit > 20 s) and in three subje cts the tablet remained in the esophagus at the end of the 10-min imaging p eriod. No stasis was observed for the oval film-coated placebo risedronate tablet. This study demonstrates that tablet size, shape and coating are pha rmaceutical parameters which can be controlled to minimize esophageal conta ct of a dosage form with esophageal tissue. (C) 2001 Elsevier Science B.V. All rights reserved.