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KMID : 0043320060290100879
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Archives of Pharmacal Research
2006 Volume.29 No. 10 p.879 ~ p.883
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Trials of Novel 13C-Urea-Containing Capsule for More Economic and Sensitive Diagnosis of Helicobacter pylori Infection in Human Subjects
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Yong Chul-Soon
Kim Yong-Il
Park San-Man
Kwon Rham
Han Hong-Hee
Park Jung-Gil
Yang Chan-Yoo
Kim Jung-Ae
Yoo Bong-Kyu
Rhee Jong-Dal
Choi Han-Gon
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Abstract
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To develop a 13C-urea-containing capsule for more economic and sensitive diagnosis of Helicobacter pylori infection, the 13C-urea-containing capsules were prepared with various additives such as polyethylene glycol, microcrystalline cellulose, sodium lauryl sulfate and citric acid. Their dissolution test and 13C-urea Breath Test in human volunteers were then performed. Polyethylene glycol increased the initial dissolution rates of urea and difference δ 13C values from 13C-urea, while microcrystalline cellulose and sodium lauryl sulfate decreased them. Irrespective of addition of citric acid, the compositions with polyethylene glycol showed higher values from 13C-urea compared to a commercial 76 mg 13C-urea-containing capsule due to higher initial dissolution rate. The capsules with 38 mg 13C-urea and 1.9 mg polyethylene glycol, which showed higher Helicobacter pylori-positive value of about 8‰ at 10 min, improved the sensitivity of 13C-urea in human volunteers. Thus, the 13C-urea-containing capsule with polyethylene glycol would be a more economical and sensitive preparation for diagnosis of Helicobacter pylori infection.
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KEYWORD
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Helicobacter pylori, Urea, Polyethylene glycol, Dissolution, 13C-Urea breath test
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