Document Detail


Effect of three different diets on the bioavailability of a sustained release lithium carbonate matrix tablet.
MedLine Citation:
PMID:  10890582     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Food-induced changes on the bioavailability of a sustained release lithium carbonate matrix tablet, which uses an acrylic matrix of Eudragit RSPM as sustaining agent, have been studied in healthy male volunteers. The tablet was developed in our laboratory using conventional technology. SUBJECTS, MATERIALS AND METHODS: The study design was a 4 x 4 Latin square involving 12 subjects who received a single dose of the tablet while fasting or with a standardized normal, high fat or high fat/high protein meal. RESULTS: The results showed no differences in half-lifebeta, renal clearance, Vdbeta, AUC, tmax, Xinfinite(u), fraction absorbed and MRT. Higher Cmax (mg/l) were obtained when the tablet was administered with any kind of meal: 2.09 +/- 0.47 (fast), 2.95 +/- 1.04 (normal diet), 2.64 +/- 0.54 (high fat diet) and 2.87 +/- 0.67 (high fat/high protein diet). The analysis of the ratio Cmax/AUC indicated that changes in Cmax were more probably due to changes in the rate of absorption. To evaluate if the magnitude of the change could be clinically relevant, Cmax and C at 12 hours (dosing interval) were treated by the superposition method in order to establish maximum and minimum concentrations at steady-state. For all the experimental conditions both concentrations would remain in the therapeutic range (4.2 10 mg/l or 0.6 - 1.4 mEq/l). CONCLUSION: The behavior of the formulation is appropriate for a sustained release tablet and fasting or non-fasting state seems not to be a major consideration for bioavailability when deciding on the regimen administration.
Authors:
M N Gai; A M Thielemann; A Arancibia
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  38     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2000 Jun 
Date Detail:
Created Date:  2000-10-19     Completed Date:  2000-10-19     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  320-6     Citation Subset:  IM    
Affiliation:
Department of Science and Pharmaceutical Technology, Faculty of Chemical and Pharmaceutical Sciences, University of Chile, Santiago.
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MeSH Terms
Descriptor/Qualifier:
Antimanic Agents / pharmacokinetics*
Biological Availability
Cross-Over Studies
Delayed-Action Preparations
Dietary Fats / administration & dosage*
Dietary Proteins / administration & dosage*
Fasting
Humans
Lithium Carbonate / administration & dosage,  pharmacokinetics*
Male
Tablets
Chemical
Reg. No./Substance:
0/Antimanic Agents; 0/Delayed-Action Preparations; 0/Dietary Fats; 0/Dietary Proteins; 0/Tablets; 554-13-2/Lithium Carbonate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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