Trials of novel13C-urea-containing capsule for more economic and sensitive diagnosis ofHelicobacter pylori infection in human subjects
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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.
Key wordsHelicobacter pylori Urea Polyethylene glycol Dissolution 13C-Urea breath test
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