期刊
PHARMACEUTICS
卷 14, 期 9, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics14091935
关键词
MRI; biorelevant dissolution; PBPK; gastric fluid; intestinal fluid; pediatrics
资金
- Research Foundation-Flanders (FWO) [G0A8119N]
- F. Hoffmann-La Roche Ltd.
This study analyzed clinical MRI data of pediatric patients and found that fluid volumes in the stomach, duodenum, jejunum, and small intestine increase with age. Body height and weight were identified as the best estimators for these fluid volumes, but no method performed ideally.
The volume and distribution of fluids available in the gastrointestinal (GI) tract may substantially affect oral drug absorption. Magnetic resonance imaging (MRI) has been used in the past to quantify these fluid volumes in adults and its use is now being extended to the pediatric population. The present research pursued a retrospective, explorative analysis of existing clinical MRI data generated for pediatric patients. Images of 140 children from all pediatric subpopulations were analyzed for their resting GI fluid volumes in fasting conditions. In general, an increase in fluid volume as a function of age was observed for the stomach, duodenum, jejunum, and small intestine (SI) as a whole. No specific pattern was observed for the ileum and colon. Body mass index (BMI), body weight, body height, and SI length were evaluated as easy-to-measure clinical estimators of the gastric and SI fluid volumes. Although weight and height were identified as the best estimators, none performed ideally based on the coefficient of determination (R-2). Data generated in this study can be used as physiologically relevant input for biorelevant in vitro tests and in silico models tailored to the pediatric population, thereby contributing to the efficient development of successful oral drug products for children.
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