期刊
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
卷 75, 期 -, 页码 131-141出版社
ELSEVIER
DOI: 10.1016/j.ejps.2015.03.001
关键词
Non-disintegrating tablet; Gastric emptying; Small intestinal transit; Colon arrival; Ileocecal junction residence; Post-dose meal intake
In this study individual data on tablet gastrointestinal transit times (i.e. gastric emptying, small intestinal transit, ileocecal junction residence, and colon arrival times) were obtained from literature in order to present and analyze their distributions and relationships. The influence of the time of food intake after tablet administration in fasted state on gastrointestinal transit times was additionally evaluated. There were 114 measurements from subjects who received the first meal at 4 h after tablet administration. Approximately 32% of the tablets arrived into the colon before the meal intake at 4 h. An evident increase in the frequency of colon arrival of tablets within 40 min after the meal intake at 4 h post-dose was observed, where approximately 39% of all tablets arrived into the colon. This is in accordance with findings described in literature where a meal ingested several hours post-dose accelerates tablet transit through the terminal ileum and shortens the transit through the small intestine. The median (min, max) of gastric emptying, small intestinal transit, and colon arrival times in the group where the first meal intake was at 4 h post-dose is 35 (0,192), 215 (60,544), and 254 (117,604) minutes, respectively. The dependence of colon arrival times on gastric emptying times was described by the nonparametric regression curve, and compared with the presumed interval of colon arrival times, calculated by summation of observed gastric emptying times and frequently cited small intestinal transit time interval, i.e. 3-4 h. For shorter gastric emptying times the trend of colon arrival times was within the presumed interval. At short gastric emptying times many observation points are also within the presumed interval since this interval coincides with short period after meal intake at 4 h post-dose. Additionally, in numerous occasions relatively long ileocecal junction residence times were obtained, which may be important information from the point of view of drug absorption. The findings of gastrointestinal transit times are important and should be taken into consideration when predicting the in vivo performance of dosage forms after oral administration. (C) 2015 Elsevier B.V. All rights reserved.
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