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Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets

By: Sadia Amin | Dr. Sualeha Riffat.
Contributor(s): Prof. Dr. Muhammad Ashraf.
Material type: materialTypeLabelBookPublisher: 2011Subject(s): Department of Pharmaoclogy & ToxicologyDDC classification: 1311,T Dissertation note: Objective of this bioequivalence study was to compare pharmacokinetic parameters and to evaluate bioequivalence of two generic drug products. A multinational company brand was compared with locally manufacture brand. It was a randomized, single dose, two-period crossover study in which 12 volunteers were participated with the age limit of 18-30yrs. These volunteers were selected according to different inclusion and exclusion criteria and the study was conducted with one week washout period. Each volunteer was one tablet of montelukast (reference or test) lOmg. 14 blood samples of 4-Sml collected at predefined time intervals i.e, 0, O.S, 1.0, 1.S, 2.0, 2.5, 3.0, 3.S, 4.0, 6.0, 8.0, 10, 12 and 24 hours .. Heparinized vacuette were used for collection of blood samples. After sampling, blood samples were centrifuged immediately to separate plasma and stored at -80°C till analyzed. Plasma montelukast concentration was evaluated by using reverse phase - high performance liquid chromatography (RP-HPLC) method. Potassium dihydrogen phosphate O.OSM at pH 3.5 with orthophosphoric acid in combination to acetonitrile (20:80) was used as mobile phase. The wavelength of detector was set at 34Snm and flow rate was set to 2.0ml per min. Drug from plasma was extracted by de-proteinizing the plasma with acetonitrile. 70 III injection volume was given to HPLC for analysis. For comparing the pharmacokinetic parameters two compartment analysis was used and pair t-test was applied. Non compartmental analysis was used for evaluating pharmacokinetic parameters to evaluate the both drugs were bioequivalent or not. 3 major parameters of bioequivalence Cmax, AVC O-inf and AVC O-t were evaluated and they did not show significant difference in between two formulations. Also the 90% confidence interval values were within the limit. So, it was concluded that both the test and reference drug were bioequivalent and test drug could be used interchangeably with the reference drug.
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Item type Current location Collection Call number Status Date due Barcode Item holds
Thesis Thesis UVAS Library
Thesis Section
Veterinary Science 1311,T (Browse shelf) Available 1311,T
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Objective of this bioequivalence study was to compare pharmacokinetic parameters
and to evaluate bioequivalence of two generic drug products. A multinational
company brand was compared with locally manufacture brand. It was a randomized,
single dose, two-period crossover study in which 12 volunteers were participated with
the age limit of 18-30yrs. These volunteers were selected according to different
inclusion and exclusion criteria and the study was conducted with one week washout
period. Each volunteer was one tablet of montelukast (reference or test) lOmg. 14
blood samples of 4-Sml collected at predefined time intervals i.e, 0, O.S, 1.0, 1.S, 2.0,
2.5, 3.0, 3.S, 4.0, 6.0, 8.0, 10, 12 and 24 hours .. Heparinized vacuette were used for
collection of blood samples. After sampling, blood samples were centrifuged
immediately to separate plasma and stored at -80°C till analyzed. Plasma montelukast
concentration was evaluated by using reverse phase - high performance liquid
chromatography (RP-HPLC) method. Potassium dihydrogen phosphate O.OSM at pH
3.5 with orthophosphoric acid in combination to acetonitrile (20:80) was used as
mobile phase. The wavelength of detector was set at 34Snm and flow rate was set to
2.0ml per min. Drug from plasma was extracted by de-proteinizing the plasma with
acetonitrile. 70 III injection volume was given to HPLC for analysis. For comparing
the pharmacokinetic parameters two compartment analysis was used and pair t-test was applied. Non compartmental analysis was used for evaluating pharmacokinetic
parameters to evaluate the both drugs were bioequivalent or not. 3 major parameters
of bioequivalence Cmax, AVC O-inf and AVC O-t were evaluated and they did not
show significant difference in between two formulations. Also the 90% confidence
interval values were within the limit. So, it was concluded that both the test and
reference drug were bioequivalent and test drug could be used interchangeably with
the reference drug.

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