Trials of novel 13C-urea-containing capsule for more economic and sensitive diagnosis of Helicobacter pylori infection in human subjects

Arch Pharm Res. 2006 Oct;29(10):879-83. doi: 10.1007/BF02973909.

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Ammonia / metabolism
  • Breath Tests / methods*
  • Capsules
  • Carbon Dioxide / metabolism
  • Carbon Isotopes
  • Cellulose / chemistry
  • Excipients / chemistry
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / metabolism
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / growth & development*
  • Humans
  • Polyethylene Glycols / chemistry
  • Sensitivity and Specificity
  • Sodium Dodecyl Sulfate / chemistry
  • Solubility
  • Time Factors
  • Urea* / chemistry
  • Urea* / pharmacokinetics

Substances

  • Capsules
  • Carbon Isotopes
  • Excipients
  • Carbon Dioxide
  • Sodium Dodecyl Sulfate
  • Polyethylene Glycols
  • Ammonia
  • Urea
  • Cellulose
  • microcrystalline cellulose