Paper Information

Title: 

EFFICACY OF URINE SAMPLES IN BIOAVAILABILITY STUDY OF CETIRIZINE, A DRUG WITH MULTIPLE PEAK PHENOMENA IN PLASMA AND URINE SAMPLES

Type: SPEECH
Author(s): SADRAEI SIMA,FAHIMI S.,TOULIAT T.,HAMIDI P.,REZAYAT S.
 
 
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

Urinary excretion of cetirizine is known to be almost 70% of the intact drug, therefore in this study the bioequivalency of two marketed formulations using both urine and plasma samples were investigated. 'Cetirizine' 10 mg tablets (generic) and 'Zyrtec' 10 mg tablets were compared in a double blind crossover study using twelve healthy male and female volunteers. The HPLC method consisted of Nucleosil 100 column C18, mobile phase: acetonitrile, methanol with 10mM potassium dihydrogen phosphate adjusted to pH 4.8 with phosphoric acid (40:7: 53 % v/v) and a flow rate of 1.4 mL/min with ultraviolet detection at a wavelength of 232 nm. Double peak phenomenon was observed in both plasma and urine samples. The 90% confidence interval of urine data are as follows: Du (0-24): 0.77-1.22, UERmax1: 0.82-2.07, UERmax2: 0.50-1.00, Tmax1:1.62-0.83 and Tmax2: 0.77-1.36. The two products were not bioequivalent. Pharmacokinetic parameters resulted from urine data correlated with their respective plasma parameters and their 90% confidence interval of the ratio of urine data to plasma data are as follows: F1U/F1P= UERmax1/Cmax1 (1.22-3.09), =UERmax2/Cmax2 ((0.58-1.73 F3U/F3P= Du (0-24)/AUC (0-24) (0.80-1.49) F4U/F4P=Ku/Kp (0.71-1.67( F5U/F5P = Tmax1-u/Tmax1-p (0.37-3.37), F6U/F6P =Tmax2-u/Tmax2-p (0.48-1.50) It is concluded that the urine data could be used for determination of the extent of drug absorbtion and rate of the elimination of cetirizine, where as for determination of absorftion rate, Cmax and Tmax of drugs with double peak phenomenon plasma data are preferred.

 
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