title: Trials of novel 13C-urea-containing capsule for more economic and sensitive diagnosis of Helicobacter pylori infection in human subjects.
abstract: 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 delta 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 per thousand 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.
authors.affiliation: College of Pharmacy, Yeungnam University, Gyongsan 712-749, Korea.
authors.forename: Chul Soon
authors.initials: CS
authors.lastname: Yong
authors.forename: Yong-Il
authors.initials: YI
authors.lastname: Kim
authors.forename: San-Man
authors.initials: SM
authors.lastname: Park
authors.forename: Rham
authors.initials: R
authors.lastname: Kwon
authors.forename: Hong-Hee
authors.initials: HH
authors.lastname: Han
authors.forename: Jung Gil
authors.initials: JG
authors.lastname: Park
authors.forename: Chan-Yoo
authors.initials: CY
authors.lastname: Yang
authors.forename: Jung-Ae
authors.initials: JA
authors.lastname: Kim
authors.forename: Bong-Kyu
authors.initials: BK
authors.lastname: Yoo
authors.forename: Jong-Dal
authors.initials: JD
authors.lastname: Rhee
authors.forename: Han-Gon
authors.initials: HG
authors.lastname: Choi
mesh_terms: D000328:Adult; D000641:Ammonia / Q000378:metabolism; D001944:Breath Tests / Q000379:methods*; D002214:Capsules; D002245:Carbon Dioxide / Q000378:metabolism; D002247:Carbon Isotopes; D002482:Cellulose / Q000737:chemistry; D005079:Excipients / Q000737:chemistry; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000378:metabolism / Q000382:microbiology; D016480:Helicobacter pylori / Q000254:growth & development*; D006801:Humans; D011092:Polyethylene Glycols / Q000737:chemistry; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D012995:Solubility; D013997:Time Factors; D014508:Urea / Q000737:chemistry / Q000493:pharmacokinetics
chemical_list: D002214:Capsules; D002247:Carbon Isotopes; D005079:Excipients; D002245:Carbon Dioxide; D012967:Sodium Dodecyl Sulfate; D011092:Polyethylene Glycols; D000641:Ammonia; D014508:Urea; D002482:Cellulose; C109691:microcrystalline cellulose