ArticleBritish journal of pharmacology2009
Proof-of-concept study on the suitability of 13C-urea as a marker substance for assessment of in vivo behaviour of oral colon-targeted dosage forms.
Article in British journal of pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 19 citations in OpenAlex.
- Trial
- Formulation of a 3D Printed Biopharmaceutical: The Development of an Alkaline Phosphatase Containing Tablet with Ileo-Colonic Release Profile to Treat Ulcerative Colitis.Pharmaceutics · 2022Article
- Towards the Oral Treatment of Ileo-Colonic Inflammatory Bowel Disease with Infliximab Tablets: Development and Validation of the Production Process.Pharmaceutics · 2019Article
- Stool microbiome reveals diverse bacterial ureases as confounders of oral urea breath testing for Helicobacter pylori and Mycobacterium tuberculosis in Bamako, Mali.Journal of breath research · 2016Article
- Use of the Biphasic (13)C-Sucrose/Glucose Breath Test to Assess Sucrose Maldigestion in Adults with Functional Bowel Disorders.BioMed research international · 2016Article
- A non-invasive, low-cost study design to determine the release profile of colon drug delivery systems: a feasibility study.Pharmaceutical research · 2012Article
- Applications of stable isotopes in clinical pharmacology.British journal of clinical pharmacology · 2011Review
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purpose(13)C-urea may be a suitable marker to assess the in vivo fate of colon-targeted dosage forms given by mouth. We postulated that release in the colon (urease-rich segment) of (13)C-urea from colon-targeted capsules would lead to fermentation of (13)C-urea by bacterial ureases into (13)CO(2). Subsequent absorption into the blood and circulation would lead to detectable (13)C (as (13)CO(2)) in breath. If, however, release of (13)C-urea occurred in the small intestine (urease-poor segment), we expected detectable (13)C (as (13)C-urea) in blood but no breath (13)C (as (13)CO(2)). The differential kinetics of (13)C-urea could thus potentially describe both release kinetics and indicate the gastrointestinal segment of release. EXPERIMENTAL APPROACH: The in vivo study consisted of three experiments, during which the same group of four volunteers participated. KEY
resultsThe kinetic model was internally valid. The appearance of (13)C-in breath CO(2) (F(fermented)) and the appearance of (13)C in blood as (13)C-urea (F(not fermented)) show a high inverse correlation (Pearson's r=-0.981, P= 0.06). The total recovery of (13)C (F(fermented)+F(not fermented)) averaged 99%, indicating complete recovery of the administered (13)C via breath and blood. (13)CO(2) exhalation was observed in all subjects. This indicates that (13)C-urea was available in urease-rich segments, such as the caecum or colon. CONCLUSIONS AND IMPLICATIONS: In this proof-of-concept study, (13)C-urea was able to provide information on both the release kinetics of a colon-targeted oral dosage form and the gastrointestinal segment where it was released.
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