The use of scintigraphy to demonstrate the rapid esophageal transit of the oval 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 rises, the incidence of solid oral dosage forms lodging in the esophagus is likely to increase and may be formulation dependent. The aim of this study was to compare the esophageal transit of the commercial film-coated risedronate tablet and a round uncoated tablet resembling the alendronate 10 mg tablet which is reported to cause esophagitis if ingested with little to no water. Water volumes of 30 ml and 50 ml were selected as these volumes can detect formulations prone to esophageal adhesion and a habits and practice study 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 crossover scintigraphy study. For both volumes of water, the film-coated placebo risedronate tablet had a statistically significant faster esophageal transit 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 tablet, five subjects had esophageal stasis (transit >20 s) and in three subjects the tablet remained in the esophagus at the end of the 10-min imaging period. No stasis was observed for the oval film-coated placebo risedronate tablet. This study demonstrates that tablet size, shape and coating are pharmaceutical parameters which can be controlled to minimize esophageal contact of a dosage form with esophageal tissue.
Perkins
A C
AC
Department of Medical Physics and Therapeutics, University Hospital, Queen's Medical Centre, NG7 2UH, Nottingham, UK. alan.perkins@nottingham.ac.uk
Wilson
C G
CG
Frier
M
M
Blackshaw
P E
PE
Dansereau
R J
RJ
Vincent
R M
RM
Wenderoth
D
D
Hathaway
S
S
Li
Z
Z
Spiller
R C
RC
D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004947:Esophagus; D012968:Etidronic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives; D005260:Female; D005772:Gastrointestinal Transit; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011877:Radionuclide Imaging; D000068296:Risedronic Acid; D013607:Tablets; D014867:Water
D002121:Calcium Channel Blockers; D013607:Tablets; D014867:Water; D000068296:Risedronic Acid; D012968:Etidronic Acid