Clinical assessment of the lag-time and t(max) of pellets with controlled release of glucose: in vitro/in vivo comparison using C-13-breath test

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F17%3A43875577" target="_blank" >RIV/62157124:16370/17:43875577 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11150/17:10365883 RIV/00179906:_____/17:10365883

Výsledek na webu

<a href="http://dx.doi.org/10.1002/bdd.2086" target="_blank" >http://dx.doi.org/10.1002/bdd.2086</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/bdd.2086" target="_blank" >10.1002/bdd.2086</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Clinical assessment of the lag-time and t(max) of pellets with controlled release of glucose: in vitro/in vivo comparison using C-13-breath test

Popis výsledku v původním jazyce

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&apos;. In this article, a C-13-glucose breath test was introduced to translate laboratory dissolution testing to clinical confirmation of the glucose release pattern using 5% abundance to differentiate the appearance of in C-13 exhaled breath. An independent two-sample t-test (p=0.20) confirmed an average clinical lag time of 300min and an in vitro time of 338min to be identical at a level of significance of =0.05. Moreover, using the same statistical method, the clinical t(max) (564min) and the in vitro t(50) (594min) 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 C-13-glucose breath test is a suitable clinical tool for lag time verification in clinical studies.

Název v anglickém jazyce

Clinical assessment of the lag-time and t(max) of pellets with controlled release of glucose: in vitro/in vivo comparison using C-13-breath test

Popis výsledku anglicky

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&apos;. In this article, a C-13-glucose breath test was introduced to translate laboratory dissolution testing to clinical confirmation of the glucose release pattern using 5% abundance to differentiate the appearance of in C-13 exhaled breath. An independent two-sample t-test (p=0.20) confirmed an average clinical lag time of 300min and an in vitro time of 338min to be identical at a level of significance of =0.05. Moreover, using the same statistical method, the clinical t(max) (564min) and the in vitro t(50) (594min) 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 C-13-glucose breath test is a suitable clinical tool for lag time verification in clinical studies.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Biopharmaceutics &amp; drug disposition

ISSN

0142-2782

e-ISSN

—

Svazek periodika

38

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

458-463

Kód UT WoS článku

000414313800002

EID výsledku v databázi Scopus

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