Sadia Amin
Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets - 2011
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.
Department of Pharmaoclogy & Toxicology
1311,T
Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets - 2011
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.
Department of Pharmaoclogy & Toxicology
1311,T