Document Detail

Clinical bioavaiability of nitrofurantoin--a case of bioinequivalence.
MedLine Citation:
PMID:  950266     Owner:  NLM     Status:  MEDLINE    
In a crossover study of the bioavailability of marketed nitrofurantoin tablets, there were significant differences in the urinary excretion of nitrofurantoin suggestive of bioavailability problems with this drug. Standard in vitro assessments of dissolution rate and disintegration time were not correlated with bioavailability and failed to detect 3 to 18 fold differences in the amount of nitrofurantoin absorbed. In fact, four lots, made by the same manufacturer had almost identical in vitro measurements (dissolution rate; distinegration time), yet two of these lots were only 6.6 and 26% as available as the reference nitrofurantoin product, and two others were comparatively available. The need for the development of an in vitro - in vivo correlation for control of lot to lot uniformity has clearly been demonstrated for nitrofurantoin. Such correlations must include tests other than those presently required.
A R DiSanto; D J Chodos; J P Phillips; K A DeSante; R G Stoll
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International journal of clinical pharmacology and biopharmacy     Volume:  13     ISSN:  0340-0026     ISO Abbreviation:  Int J Clin Pharmacol Biopharm     Publication Date:  1976 Apr 
Date Detail:
Created Date:  1976-10-02     Completed Date:  1976-10-02     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7505527     Medline TA:  Int J Clin Pharmacol Biopharm     Country:  GERMANY, WEST    
Other Details:
Languages:  eng     Pagination:  220-7     Citation Subset:  IM    
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MeSH Terms
Biological Availability
Nitrofurantoin / metabolism*,  standards
Quality Control
Therapeutic Equivalency
Reg. No./Substance:
0/Tablets; 67-20-9/Nitrofurantoin

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

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