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Clinical assessment of the lag‐time and t max of pellets with controlled release of glucose: in vitro / in vivo comparison using 13 C–breath test
Author(s) -
Neumann David,
Muselík Jan,
Sabadková Dana,
Pavloková Sylvie,
Špirková Jana,
Franc Aleš
Publication year - 2017
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2086
Subject(s) - insulin , in vivo , pellets , lag time , diabetes mellitus , clinical significance , in vitro , carbohydrate , pellet , chemistry , medicine , pharmacology , endocrinology , biochemistry , biology , microbiology and biotechnology , paleontology , biological system , zoology
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 t max (564 min) and the in vitro t 50 (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.