Maintaining a stable glycaemia in diabetes mellitus type 1 requires flexible insulin administration and carbohydrate intake to affected individuals. In real life, there might be some situations limiting the insulin-sugar balance control, e.g. night sleep or prolonged sporting activities. Glucose pellets with a pre-determined time lag between the pellet administration and glucose release were developed to mimic a 'snack eaten in advance'. In this article, a 13 C-glucose breath test was introduced to translate laboratory dissolution testing to clinical confirmation of the glucose release pattern using 5% δ abundance to differentiate the appearance of in 13 C exhaled breath. An independent two-sample t-test (p = 0.20) confirmed an average clinical lag time of 300 min and an in vitro time of 338 min to be identical at a level of significance of α = 0.05. Moreover, using the same statistical method, the clinical tmax (564 min) and the in vitro t50 (594 min) were also considered identical (p = 0.34). It was concluded that dissolution testing is a relevant method to determine the time lags of dosage forms with controlled release of glucose and that the 13 C-glucose breath test is a suitable clinical tool for lag time verification in clinical studies.
- Klíčová slova
- 13C-breath test, controlled release dosage form, diabetes mellitus type 1, hypoglycemia, in vivo/in vitro evaluation,
- MeSH
- dechové testy * MeSH
- dospělí MeSH
- glukosa aplikace a dávkování chemie farmakokinetika MeSH
- izotopy uhlíku farmakokinetika MeSH
- léky s prodlouženým účinkem aplikace a dávkování chemie farmakokinetika MeSH
- lidé středního věku MeSH
- lidé MeSH
- tobolky MeSH
- uvolňování léčiv MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- Názvy látek
- glukosa MeSH
- izotopy uhlíku MeSH
- léky s prodlouženým účinkem MeSH
- tobolky MeSH
