Document Detail


Clinical bioavaiability of nitrofurantoin--a case of bioinequivalence.
MedLine Citation:
PMID:  950266     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
A R DiSanto; D J Chodos; J P Phillips; K A DeSante; R G Stoll
Related Documents :
16880646 - Evaluation of the disintegration properties of commercial famotidine 20 mg orally disin...
15726566 - Techniques and parameters used in compatibility tests between beauveria bassiana (bals)...
14603516 - Once-a-day controlled-release dosage form of divalproex sodium ii: development of a pre...
18498516 - What are meters measuring?
1451486 - Studies on the allergenicity of baltic amber.
15672476 - Cow's milk allergens identification by two-dimensional immunoblotting and mass spectrom...
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    
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Adult
Biological Availability
Humans
Male
Nitrofurantoin / metabolism*,  standards
Quality Control
Solubility
Tablets
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Tablets; 67-20-9/Nitrofurantoin

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


Previous Document:  Methods of measuring physical fitness.
Next Document:  Continuous measurement of vascular diameters via television microscopy.