| The bioavailability of diclofenac from enteric coated products in healthy volunteers with normal and artificially decreased gastric acidity. | |
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MedLine Citation:
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PMID: 7888605 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The relative bioavailability of four monolithic enteric coated (MEC) diclofenac products was compared in 16 healthy volunteers. Only one generic product was fully bioequivalent with the reference product Voltaren with regard to AUC, Cmax, and tlag. Two products showed significant differences in tlag. In a second experiment with eight volunteers the influence of increased gastric pH (ranitidine treatment) on the two mutually most differing products was studied. They showed equivalence in AUC, but not in Cmax. Analysis of tlag suggests that the product with the low tlag disintegrates within the non-acid stomach, whereas the product with the long tlag passes the non-acid stomach intact. Several in vitro dissolution tests were conducted. The European Pharmacopeia test did not detect any differences between the products. At pH 5, both with and without mechanical stress, only the product with the shortest tlag released diclofenac. The in vivo results were best predicted by the in vitro dissolution tests performed at several fixed pH values with mechanical stress. |
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Authors:
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M E Van Gelderen; M Olling; D M Barends; J Meulenbelt; P Salomons; A G Rauws |
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Publication Detail:
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Type: Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Biopharmaceutics & drug disposition Volume: 15 ISSN: 0142-2782 ISO Abbreviation: Biopharm Drug Dispos Publication Date: 1994 Dec |
Date Detail:
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Created Date: 1995-04-17 Completed Date: 1995-04-17 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7911226 Medline TA: Biopharm Drug Dispos Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 775-88 Citation Subset: IM |
Affiliation:
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National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Biological Availability Diclofenac / administration & dosage, blood, pharmacokinetics* Female Gastric Acid / physiology* Humans Hydrogen-Ion Concentration Male Quality Control Solubility Spectrophotometry, Ultraviolet Tablets, Enteric-Coated |
| Chemical | |
Reg. No./Substance:
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0/Tablets, Enteric-Coated; 15307-86-5/Diclofenac |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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