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http://dx.doi.org/10.4333/KPS.2002.32.1.007

Development of 13C-urea-containing capsule for diagnosis of H. pylori  

Yong, Chul-Soon (College of Pharmacy, Yeungnam University)
Kim, Yong-Il (College of Pharmacy, Yeungnam University)
Kim, Chi-Man (Medichems Co., LTD.)
Kang, Sung-Hoon (Medichems Co., LTD.)
Quan, Qi-Zhe (College of Pharmacy, Yeungnam University)
Rhee, Jong-Dal (College of Pharmacy, Yeungnam University)
Kim, Chong-Kook (College of Pharmacy, Seoul National University)
Sah, Hong-Kee (College of Pharmacy, Catholic University of Daegu)
Choi, Han-Gon (College of Pharmacy, Yeungnam University)
Publication Information
Journal of Pharmaceutical Investigation / v.32, no.1, 2002 , pp. 7-11 More about this Journal
Abstract
The purpose of this study was to develop a new $^{l3}C-urea-containing$ capsule for diagnosis of H. pylori. The urea-containing capsules were prepared with various diluents such as polyethylene glycol (PEG), microcrystalline cellulose, sodium lauryl sulfate and citric acid. The dissolution test, $^{l3}C-urea$ breath test and stability test were then performed on the capsules. Microcrystalline cellulose and sodium lauryl sulfate retarded the initial dissolution rates of urea. However, PEG increased the initial dissolution rates of urea. Furthermore, two formulae composed of PEG, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] and [$^{l3}C-urea/PEG/citric$ acid (38/1.9/1.9 mg/cap)] had the maximum DOB value, about 16 at 20 mim, while the formula composed of only 38 mg $^{l3}C-urea$ had the maximum DOB value at 30 min. The results indicated that PEG improved the, sensitivity of $^{l3}C-urea$ in the human volunteers. The capsule [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] was stable for at least six months in 25 and $37^{\circ}C$. Thus, a PEG-containing capsule, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] would be a more economical, sensitive and stable preparation for diagnosis of H. pylori.
Keywords
H. pylori; urea; polyethylene glycol; dissolution test; $^{l3}C-urea$ breath test;
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