Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects.
BACKGROUND
Risedronate sodium is a pyridinyl bisphosphonate, proven effective for the treatment and prevention of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis and Paget's disease of the bone.


OBJECTIVE
To compare the oesophageal transit, disintegration and gastric emptying of the commercial film-coated risedronate tablet in subjects with gastro-oesophageal reflux disease (GERD) and normal control subjects.


METHODS
A total of 30 subjects, 15 patients with GERD and 15 age- and sex-matched, normal control subjects, participated in a single-centre, open-label, comparative gamma scintigraphy study. The GERD subjects had active erosive oesophagitis within 4 weeks prior to dosing.


RESULTS
The mean oesophageal transit (GERD, 4.4 s; controls, 3.1 s), mean disintegration (GERD, 21.8 min; controls, 19.2 min) and mean gastric emptying (GERD, 15.9 min; controls, 15.0 min) were similar in the two subject groups. The oesophageal transit is rapid and given the rapid disintegration and gastric emptying, oesophageal contact occurring via reflux of risedronate was unlikely since most, if not all, of the dosage form exited from the stomach within 30 min.


CONCLUSIONS
The oval shape and film-coating on the commercial risedronate tablet promotes rapid oesophageal transit and minimizes oesophageal contact, even in the high-risk GERD population.
Perkins
A C
AC
University Hospital, Queen's Medical Centre, Nottingham, UK. alan.perkins@nottingham.ac.uk
Wilson
C G
CG
Frier
M
M
Blackshaw
P E
PE
Juan
D
D
Dansereau
R J
RJ
Hathaway
S
S
Li
Z
Z
Long
P
P
Spiller
R C
RC
D000368:Aged; D000369:Aged, 80 and over; D004947:Esophagus / Q000378:metabolism*; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D005260:Female; D005746:Gastric Emptying; D005764:Gastroesophageal Reflux / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068296:Risedronic Acid
D000068296:Risedronic Acid; D012968:Etidronic Acid