To develop a13C-urea-containing capsule for more economic and sensitive diagnosis ofHelicobacter pylori infection, the13C-urea-containing capsules were prepared with various additives such as polyethylene glycol, microcrystalline cellulose, sodium lauryl sulfate and citric acid. Their dissolution test and13C-urea Breath Test in human volunteers were then performed. Polyethylene glycol increased the initial dissolution rates of urea and difference δ13C values from13C-urea, while microcrystalline cellulose and sodium lauryl sulfate decreased them. Irrespective of addition of citric acid, the compositions with polyethylene glycol showed higher values from13C-urea compared to a commercial 76 mg13C-urea-containing capsule due to higher initial dissolution rate. The capsules with 38 mg13C-urea and 1.9 mg polyethylene glycol, which showed higherHelicobacter pylori-positive value of about 8%. at 10 min, improved the sensitivity of13C-urea in human volunteers. Thus, the13C-urea-containing capsule with polyethylene glycol would be a more economical and sensitive preparation for diagnosis ofHelicobacter pylori infection.
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Bielanski, W., and Konturek, S. J., New approach to13C-urea breath test: capsule-based modification with low-dose of 13C-urea in the diagnosis of Helicobacter pylori infection.J. Physiol. Pharmacol., 47, 545–553 (1996).
Choi, H. G., Yong, C. S., and Kim, C. K., Development of terfenadine-pseudoephedrine double layered tablet dissolution-equivalent to core tablet.Drug Dev. Ind. Pharm., 26, 605–611 (2000).
Eggers, R. H., Kulp, A., Tegeler, R., Ludke, F. E., Lepsien, G., Meyer, B., and Bauer, F. E., A methodological analysis of the (13)C-urea breath test for detection of Helicobacter pylori infections: high sensitivity and specificity within 30 min using 75 mg of (13)C-urea.Eur. J. Gastroen. Hepat., 2, 437–444 (1990).
Faigel, D. O., Childs, M., Furth, E. E., Alavi, A., and Metz, D. C., New noninvasive tests for Helicobacter pylori gastritis. Comparison with tissue-based gold standard.Digest. Dis. Sci., 41, 740–748 (1996).
Graham, D. Y., Malaty, H. M., Cole, R. A., Martin, R. F., and Klein, P. D., Simplified13C-urea breath test for detection of Helicobacter pylori infection.Am. J. Gastroentero., 96, 1741–1745 (2001).
Grimley, C. E., Penny, A., O’sullivan, M., Shebani, M., Lismore, J. R., Cross, R., Illing, R. C., Loft, D. E., and Nwokolo, C. U., Comparison of two 3-day Helicobacter pylori eradication regimens with a standard 1-week regimen.Aliment Pharm. Therap., 13, 869–873 (1999).
Hamlet, A. K., Erlandsson, K. I., Olbe, L., Svennerholm, A. M., Backman, V. E., and Pettersson, A. B., A simple, rapid, and highly reliable capsule-based14C urea breath test for diagnosis of Helicobacter pylori infection.Scand. J. Gastroentero., 30, 1058–1063 (1995).
Hamlet, L., Stage, H., Lonroth, C., Cahlin, Nystrom, C., and Pettersson, A., A novel tablet-based13C urea breath test for Helicobacter pylori with enhanced performance during acid suppression therapy.Scand. J. Gastroentero., 34, 367–374 (1999).
Lee, E. J., Lee, S. W., Choi, H. G., and Kim, C. K., Biovailability of cyclosporin A dispersed in sodium lauryl sulfate-dextrin based solid microspheres.Int. J. Pharm., 218, 125–131 (2001).
Lerang, F., Haug, J. B., Moum, B., Mowinckel, P., Berge, T., Ragnhildstveit, E., and Bjorneklett, A., Accuracy of IgG serology and other tests in confirming Helicobacter pylori eradication.Scand. J. Gastroentero., 33, 710–715 (1998).
Logan, R. P. H., Urea breath tests in the management of Helicobacter pylori infection.Gut, 43 S47-S50 (1998).
Parente, F., and Bianchi, P. G., The (13)C-urea breath test for non-invasive diagnosis of Helicobacter pylori infection: which procedure and which measuring equipment?Eur. J. Gastroen. Hepat., 13, 803–806 (2001).
Peura, D. A., Pambianco, D. J., Dye, K. R., Lind, C., Frierson, H. F., Hoffman, S. R., Combs, M. J., Guilfoyle, E., and Marshall B. J., Microdose13C-urea breath test offers diagnosis of Helicobacter pylori in 10 minutes.Am. J. Gastroenterol., 91, 233–238 (1996).
Prewett, E. J., Luk, Y. W., Fraser, A. G., Lam, W. M. and Pounder, R. E., Comparison of one-day oral dosing with three bismuth compounds for the suppression of Helicobacter pylori assessed by the13C-urea breath test.Aliment Pharm. Therap., 6, 97–102 (1992).
Rouchotas, C., Cassidy, O. E., and Rowley, G., Comparison of surface modification and solid dispersion techniques for drug dissolution.Int. J. Pharm., 195, 1–6 (2000).
Savarino, V., Vigneri, S., and Celle, G., The13C urea breath test in the diagnosis of Helicobacter pylori infection.Gut, 45, S118-S122 (1999).
Stavchansky, S., and Gowan, W. G., Evaluation of the bioavailability of a solid dispersion of phenytoin in polyethylene glycol 6000 and a commercial phenytoin sodium capsule in the dog.J. Pharm. Sci., 73, 733–736 (1984).
Yamamoto, K., Nakano, M., Arita, T., Takayama, Y., and Nakai, Y., Dissolution behavior and bioavailability of phenytoin from a ground mixture with microcrystalline cellulose.J. Pharm. Sci., 65, 1484–1488 (1976).
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Yong, C.S., Kim, Y., Park, S. et al. Trials of novel13C-urea-containing capsule for more economic and sensitive diagnosis ofHelicobacter pylori infection in human subjects. Arch Pharm Res 29, 879–883 (2006). https://doi.org/10.1007/BF02973909
- Helicobacter pylori
- Polyethylene glycol
- 13C-Urea breath test