Document Detail

Intragastric volume changes after intake of a high-caloric, high-fat standard breakfast in healthy human subjects investigated by MRI.
MedLine Citation:
PMID:  24697247     Owner:  NLM     Status:  Publisher    
The aim of this magnetic resonance imaging (MRI) study was to investigate gastric emptying after intake of a high-caloric and high-fat standard meal as recommended by FDA and EMA for food-effect bioavailability and fed bioequivalence studies. 12 healthy human subjects (7 male, 5 female) received the standard meal after an overnight fast. MRI was performed before as well as 15, 25, 35, 45, 55, 65, 105, 195, 275 and 375 min after meal intake using strong T2-weighted sequences and chemical shift imaging. In addition, 30 min after beginning of meal intake subjects ingested 240 mL of water representing the recommended co-administration of water during drug intake. Gastric content volume was assessed using T2-weighted images and fat fraction was estimated using a calculation of fat fraction in chemical shift imaging. In addition, the existence of a mechanism allowing fast gastric emptying of water in the fed state was investigated. After a lag phase of 50-90 min, gastric content volume decreased constantly with a rate of 1.7 mL/min. The water ingested 30 min after start of the meal intake directly reached the antrum and subsequently, was emptied quickly from the human stomach. Complete gastric emptying within 6 h was observed in only one out of 12 subjects. The fat fraction of the intragastric chyme decreased from 9.5% directly after meal intake to 6.3% at the end of the experiments. Moreover, the fat fraction in fundus was significantly higher compared to the antrum. This study contributes fundamental data for the assessment of food effects of solid oral dosage forms.
Mirko Koziolek; Michael Grimm; Grzegorz Garbacz; Jens-Peter Kühn; Werner Weitschies
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-4-3
Journal Detail:
Title:  Molecular pharmaceutics     Volume:  -     ISSN:  1543-8392     ISO Abbreviation:  Mol. Pharm.     Publication Date:  2014 Apr 
Date Detail:
Created Date:  2014-4-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101197791     Medline TA:  Mol Pharm     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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