Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects

A. C. Perkins, C. G. Wilson, M. Frier, P. E. Blackshaw, D. Juan, R. J. Dansereau, S. Hathaway, Z. Li, P. Long, R. C. Spiller

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Aim: 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.
Original languageEnglish
Pages (from-to)115-121
Number of pages6
JournalAlimentary Pharmacology and Therapeutics
Volume15
Issue number1
DOIs
Publication statusPublished - 1 Jan 2001

Keywords

  • oesophageal transit
  • gastric emptying
  • gastro-oesophageal reflux disease
  • Risedronate sodium is a pyridinyl bisphosphonate
  • commercial film-coated risedronate tablet

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