Clinical assessment of the lag ‐time and tmax of pellets with controlled release of glucose: in‐vitro/in‐vivo comparison using 13C‐breath test

Abstract Maintaining a stable glycemia in diabetes mellitus type 1 requires flexible insulin application and carbohydrates intake to affected individuals. In real life, there might be some situations limiting the insulin‐sugar balance control, e.g. night sleep or prolonged sport activities. Glucose pellets with pre‐determined time lag between pellet administration and glucose release were developed to mimic "snack eaten in advance". In this article, 13C‐glucose breath test is introduced to translate the laboratory dissolution testing to clinical confirmation of the glucose release pattern using 5 per cent of δ abundance to differentiate 13C appearance in exhaled breath. Independent two‐sample t‐test (p‐value = 0.20) confirmed average clinical lag time of 300 minutes and in‐vitro of 338 minutes as identical at a level of significance α = 0.05. Moreover, using the same statistical method, clinical tmax (564 min) and in‐vitro t50 (594 min) were also considered as identical (p‐value = 0.34). It was concluded that dissolution testing is a relevant method to determine time lags of dosage forms with controlled release of glucose and 13C‐glucose breath test is a suitable clinical tool for lag time verification in clinical studies.
Source: Biopharmaceutics and Drug Disposition - Category: Drugs & Pharmacology Authors: Tags: ORIGINAL PAPER Source Type: research