Trials of novel 13C-urea-containing capsule for more economic and sensitive diagnosis of Helicobacter pylori infection in human subjects.
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.
Yong
Chul Soon
CS
College of Pharmacy, Yeungnam University, Gyongsan 712-749, Korea.
Kim
Yong-Il
YI
Park
San-Man
SM
Kwon
Rham
R
Han
Hong-Hee
HH
Park
Jung Gil
JG
Yang
Chan-Yoo
CY
Kim
Jung-Ae
JA
Yoo
Bong-Kyu
BK
Rhee
Jong-Dal
JD
Choi
Han-Gon
HG
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
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