| Bioavailability and pharmacokinetic properties of 2 sustained-release formulations of diclofenac sodium, Voltaren vs inflaban: effect of food on inflaban bioavailability. | |
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MedLine Citation:
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PMID: 8996854 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In this study, in vitro characterization, bioavailability and pharmacokinetics of 2 different sustained-release diclofenac sodium dosage forms were compared, Voltaren (100 mg tablets), manufactured by Ciba-Geigy and Inflaban (100 mg enteric-coated tablets), manufactured by the Arab Pharmaceutical Manufacturing Company. The in vitro results demonstrated a faster rate of dissolution for Inflaban as compared to Voltaren, but both products exhibited a sustained-release pattern. The bioavailability study was conducted on 20 healthy male subjects who received a single oral dose (100 mg) of each product according to a randomized 2-way crossover design. Blood samples were obtained over a 26-hour period, and drug concentrations were determined by an HPLC method. Concentration time profiles revealed a sustained-release pattern for both products. The Tlag for Voltaren was 0.8 +/- 0.2 h, significantly shorter than for Inflaban (1.7 +/- 0.2 h) indicating a faster rate of absorption from the upper gastrointestinal tract. The Cmax obtained with Voltaren was significantly higher than that obtained with Inflaban (1,161 +/- 102 and 799 +/- 83, respectively). With respect to Tmax and AUC0-26h parameters, both products were not found to be statistically different. Tmax for Voltaren and Inflaban was 4.2 +/- 0.5 and 4.5 +/- 0.4 h, respectively, whereas AUC0-26h values for both products were 5,423 +/- 562 and 5,237 +/- 520 ng x h/ml, respectively. It is believed that the observed differences between Voltaren and Inflaban are mainly due to the fact that Inflaban is designed as an enteric-coated tablet form, with a core tablet having different sustained-release behavior. In addition, the effect of food on the bioavailability of Inflaban was evaluated in randomly selected 6 male volunteers. Our results revealed that, following light and heavy meals, the AUC0-30 and Cmax were minimally affected by food whereas a significant increase in Tmax and Tlag as compared to fasting conditions was observed. |
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Authors:
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S Zmeili; M Hasan; N Najib; E Sallam; S Deleq; M Shubair |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: International journal of clinical pharmacology and therapeutics Volume: 34 ISSN: 0946-1965 ISO Abbreviation: Int J Clin Pharmacol Ther Publication Date: 1996 Dec |
Date Detail:
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Created Date: 1997-05-28 Completed Date: 1997-05-28 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9423309 Medline TA: Int J Clin Pharmacol Ther Country: GERMANY |
Other Details:
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Languages: eng Pagination: 564-70 Citation Subset: IM |
Affiliation:
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Department of Pharmacology, Faculty of Medicine, University of Jordan, Amman, Jordan. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-Inflammatory Agents, Non-Steroidal / administration & dosage, chemistry, pharmacokinetics* Area Under Curve Biological Availability Delayed-Action Preparations Diclofenac / administration & dosage, chemistry, pharmacokinetics* Female Food-Drug Interactions* Humans Male |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Delayed-Action Preparations; 15307-86-5/Diclofenac |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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