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Variation in Gastrointestinal Transit of Pharmaceutical Dosage Forms in Healthy Subjects

Coupe, Alastair J., Davis, Stanley S., Wilding, Ian R.·1991·Pharmaceutical Research
DOI 10.1023/a:1015849700421
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Abstract

The variability in the gastrointestinal transit of a multiple-unit and single-unit dosage form was investigated following a light breakfast in six, healthy, male volunteers after repeated weekly administration. The dosage forms were labeled with gamma-emitting radionuclides and the transit of the formulations was monitored on 4 separate study days using the technique of dual-isotope gamma scintigraphy. Gastric emptying times and small intestinal transit times were calculated and compared statistically within and between subjects using the standard deviation and coefficient of variance. The variability in gastric emptying of single- and multiple-unit systems was large; the intrasubject variation being less than the intersubject. There was less variation in small intestinal transit times for the single- and multiple-unit formulations than in gastric emptying, intrasubject variation again being less than intersubject variation.

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Research works printed but not linked: 23

  1. D. L. Casey, R. M. Beihn, G. A. Digenis, and M. B. Shambu. Method for monitoring hard gelatin capsule disintegration times in humans using external scintigraphy. J. Pharm. Sci. 65:1412–1413 (1976). · DOI
  2. M. Alpsten, G. Enkeved, and L. Solvell. A profile scanning method of studying the release properties of different types of tablets in man. Acta. Pharm. Suec. 13:107–122 (1976).
  3. F. N. Christensen, S. S. Davis, J. G. Hardy, M. J. Taylor, D. R. Whalley, and C. G. Wilson. The use of gamma scintigraphy to follow the gastrointestinal transit of pharmaceutical formulations. J. Pharm. Pharmacol. 37:91–95 (1985). · DOI
  4. S. S. Davis, J. G. Hardy, M. J. Taylor, D. R. Whalley, and C. G. Wilson. A comparative study of the gastrointestinal transit of a pellet and tablet formulation. Int. J. Pharm. 21:167–177 (1984). · DOI
  5. R. Khosla and S. S. Davis. The effect of polycarbophil on the gastric emptying of pellets. J. Pharm. Pharmacol. 39:47–49 (1987). · DOI
  6. S. S. Davis, A. F. Stockwell, M. J. Taylor, J. G. Hardy, D. R. Whalley, C. G. Wilson, H. Bechgaard, and F. N. Christensen. The effect of density on the gastric emptying of single-and multiple-unit dosage forms. Pharm. Res. 3:208–213 (1986). · DOI
  7. L. C. Kaus and J. T. Fell. Effect of stress on the gastric emptying of capsules. J. Clin. Hosp. Pharm. 9:249–251 (1984).
  8. R. Khosla and S. S. Davis. The gastric emptying of pellets in supine volunteers. J. Pharm. Pharmacol. 38(suppl.):10P (1986). · DOI
  9. C. M. Brophy, J. G. Moore, P. E. Christian, M. J. Egger, and A. T. Taylor. Variability of gastric emptying measurements in man employing standardized radiolabeled meals. Digest. Dis. Sci. 31:799–806 (1986). · DOI
  10. O. U. Petring and H. Flachs. Inter-and intrasubject variability of gastric emptying in healthy volunteers measured by scintigraphy and paracetamol absorption. Br. J. Clin. Pharmac. 29:703–708 (1990). · DOI
  11. L. C.Feely. Controlled Release Hydroxyphophylmethylcellulose Mini-Matrices, Ph.D. thesis, University of Nottingham, Nottingham, 1986
  12. S. S. Davis, 1987, Int. J. Pharm., 35, 253, 10.1016/0378-5173(87)90137-2 · DOI
  13. S. S. Davis, J. G. Hardy, and J. W. Fara. Transit of pharmaceutical dosage forms through the small intestine. Gut 27:886–892 (1986). · DOI
  14. S. S. Davis, J. G. Hardy, M. J. Taylor, D. R. Whalley, and C. G. Wilson. The effect of food on the gastrointestinal transit of pellets and an osmotic device (Osmet). Int. J. Pharm. 21:331–340 (1984). · DOI
  15. R. A. Hinder and K. A. Kelly. Canine gastric emptying of solids and liquids. Am. J. Physiol. 233:E335–E340 (1977).
  16. C. F. Code and J. M. Marlett. The interdigestive myo-electric complex of the stomach and small bowel of dogs. J. Physiol. (Lond.) 246:289–309 (1975). · DOI
  17. S. S. Davis, F. N. Christensen, R. Khosla, and L. C. Feely. Gastric emptying of large single-unit dosage forms. J. Pharm. Pharmacol. 40:205–207 (1988). · DOI
  18. R. Khosla, L. C. Feely, and S. S. Davis. Gastrointestinal transit of non-disintegrating tablets in fed subjects. Int. J. Pharm. 53:107–117 (1989). · DOI
  19. H. J. Smith and M. Feldman. Influence of food and marker length on the gastric emptying of indigestible radioopaque markers in healthy humans. Gastroenterology 91:1452–1455 (1986). · DOI
  20. J. Munk, R. Gannaway, M. Hoare, and A. Johnson. Direct measurement of pyloric diameter and tone in man and their response to cholecystokinin. In H. L. Duthie (ed.), Gastrointestinal Motility in Health and Disease, MTP Press, Lancaster, 1978, pp. 349–356. · DOI
  21. N. Ramsbottom and J. N. Hunt. Effect of exercise on gastric emptying and gastric secretion. Digestion 10:1–8 (1974). · DOI
  22. E. Hunter, J. T. Fell, and H. Sharma. The gastric emptying of pellets contained in hard gelatin capsules. Drug Dev. Ind. Pharm. 8:751–757 (1982). · DOI
  23. K. J. Ollerenshaw, S. Norman, C. G. Wilson, and J. G. Hardy. Exercise and small intestinal transit. Nucl. Med. Commun. 8:105–110 (1987). · DOI

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Metadata

Authors
Coupe, A. J., Davis, S. S., & Wilding, I. R.
Venue
Pharmaceutical Research
Publisher
Springer Science and Business Media LLC
Published
1991-03
Volume
8
Issue
3
Pages
360-364
ISSN
  • 0724-8741
  • 1573-904X
DOI
10.1023/a:1015849700421
Cited by
231
References
0
Language
en
Licence

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