Document Detail


Bioequivalence of pyrantel pamoate dosage forms in healthy human subjects.
MedLine Citation:
PMID:  7993990     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Drugs that are largely restricted to the gastro-intestinal tract (GIT) for their therapeutic efficacy and that are not substantially absorbed into the body are usually inadequately studied in terms of systemic bioavailability. The possibility of systemic effects requires that bioavailabilities be studied to ensure against enhanced toxicity resulting from formulation differences. Pyrantel pamoate falls into this category. High-performance liquid chromatography was employed in this study to determine plasma levels of pyrantel in nine healthy human subjects after administration of tablet and suspension dosage forms. Mean peak plasma concentrations of 37.56 +/- 9.37, 35.89 +/- 8.94, and 36.22 +/- 10.10 ng mL-1 were obtained following administration of 750 mg pyrantel pamoate in three different formulations. The mean tmax values were 2.02 +/- 0.12, 2.05 +/- 0.356, and 2.05 +/- 0.339 h respectively for the above dosage forms; the respective AUC0-9 values were 81.01 +/- 12.97, 94.59 +/- 17.18, and 101.47 +/- 19.59 h ng mL-1. There was no statistically significant difference between the bioavailabilities of the dosage forms tested. Large inter-subject variations were observed. One subject experienced abdominal discomfort and one experienced dizziness. It was not possible to clearly correlate individual variations in absorption with the observed adverse effect because the number of incidents was low (two out of 27 treatments).
Authors:
A A Fasanmade; A O Akanni; A A Olaniyi; A A Fasanmade; F Tayo
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Biopharmaceutics & drug disposition     Volume:  15     ISSN:  0142-2782     ISO Abbreviation:  Biopharm Drug Dispos     Publication Date:  1994 Aug 
Date Detail:
Created Date:  1995-01-17     Completed Date:  1995-01-17     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7911226     Medline TA:  Biopharm Drug Dispos     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  527-34     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutical Chemistry, College of Medicine, University of Ibadan, Nigeria.
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MeSH Terms
Descriptor/Qualifier:
Adult
Biological Availability
Chromatography, High Pressure Liquid
Cross-Over Studies
Drug Evaluation
Humans
Intestinal Absorption / physiology
Male
Pyrantel Pamoate / administration & dosage,  adverse effects,  blood,  pharmacokinetics*
Suspensions / metabolism
Tablets / metabolism
Chemical
Reg. No./Substance:
0/Suspensions; 0/Tablets; 22204-24-6/Pyrantel Pamoate

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


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