| A mechanism-based approach for absorption modeling: the Gastro-Intestinal Transit Time (GITT) model. | |
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MedLine Citation:
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PMID: 22286919 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Absorption models used in the estimation of pharmacokinetic drug characteristics from plasma concentration data are generally empirical and simple, utilizing no prior information on gastro-intestinal (GI) transit patterns. Our aim was to develop and evaluate an estimation strategy based on a mechanism-based model for drug absorption, which takes into account the tablet movement through the GI transit. This work is an extension of a previous model utilizing tablet movement characteristics derived from magnetic marker monitoring (MMM) and pharmacokinetic data. The new approach, which replaces MMM data with a GI transit model, was evaluated in data sets where MMM data were available (felodipine) or not available (diclofenac). Pharmacokinetic profiles in both datasets were well described by the model according to goodness-of-fit plots. Visual predictive checks showed the model to give superior simulation properties compared with a standard empirical approach (first-order absorption rate + lag-time). This model represents a step towards an integrated mechanism-based NLME model, where the use of physiological knowledge and in vitro–in vivo correlation helps fully characterize PK and generate hypotheses for new formulations or specific populations. |
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Authors:
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Emilie Hénin; Martin Bergstrand; Joseph F Standing; Mats O Karlsson |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The AAPS journal Volume: 14 ISSN: 1550-7416 ISO Abbreviation: AAPS J Publication Date: 2012 Jun |
Date Detail:
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Created Date: 2012-06-01 Completed Date: 2013-01-28 Revised Date: 2013-06-13 |
Medline Journal Info:
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Nlm Unique ID: 101223209 Medline TA: AAPS J Country: United States |
Other Details:
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Languages: eng Pagination: 155-63 Citation Subset: IM |
Affiliation:
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Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. Emilie.henin@gmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Delayed-Action Preparations / administration & dosage, pharmacokinetics Diclofenac / administration & dosage, pharmacokinetics Felodipine / administration & dosage, pharmacokinetics* Gastrointestinal Transit / drug effects, physiology* Humans Intestinal Absorption / drug effects, physiology* Models, Biological* Tablets |
| Chemical | |
Reg. No./Substance:
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0/Delayed-Action Preparations; 0/Tablets; 15307-86-5/Diclofenac; 72509-76-3/Felodipine |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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