1.
Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets
by Sadia Amin | Dr. Sualeha Riffat | Prof. Dr. Muhammad Ashraf.
Material type: ; Format:
print
; Nature of contents: ; Literary form: Publisher: 2011Dissertation 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.
Availability: Items available for loan: UVAS Library [Call number: 1311,T] (1).
2.
Bioequivalence Study Of Deferiprone In Healthy Volunteers
by Naila Waheed | Dr. Sualeha Riffat | Prof. Dr. Muhammad Ashraf.
Material type: ; Format:
print
; Literary form:
not fiction
Publisher: 2011Dissertation note: The study was conducted with the aim of evaluating bioequivalence, relative
silability and efficacy of deferiprone manufactured locally (Ferinil, Global
aceutical, Pakistan) with a reference drug (Ferriprox, ApoPharma, Canada) in healthy
volunteers. It was a randomized crossover study enrolling 12 volunteers within age limit
g·55yrs and meeting the inclusion and exclusion criteria of the study, Each volunteer was
administered two tablets of deferiprone 500mg of both reference and test drug with a two-
washout period. Blood samples of about 5ml was collected at 0, 0.25, 0.5, 0.75, 1, 1.5, 5,4, 6, 8, 12 hour at predetermined time intervals and one sample was taken as control
giving first dose to volunteers. Heparinized vacuette was used for collection of blood
les. After sampling, blood samples was centrifuged at approximately 3000 rpm for 10
les and then stored at -80°C till analyzed. Plasma deferiprone levels were analyzed using
led High pressure liquid chromatography (HPLC) method. Pharmacokinetic parameters
calculated from plasma concentration time curve non-compartmentally and two-
artmental. After logarithmic transformation of data statistical comparisons of Cmax,
(0-1), AUC(o.oo) was calculated and appropriate statistical method was used for calculation. mean relative bioavailability was 104% and was proved to be bioavailable. The Cmax
(mean ±SD) for reference and test drug was 12.68 ± 4.91 and 14.41 ± 5.04 ug/ml,
ctively while average ± SD of AUCO-t and AUCO-inf of test and reference drug was 40.49
6,05 and 42.84 ± 18.47 ugh/ml and 38.63 ± 13.65 and 40.75 ± 14.17 ugh/ml. Average
(test/reference) of Cmax 90% CI was 0.9876-1.3125. Average ratio (test/reference) of
Co.190% CI was 0.9737-1.1150, and of AUCo-inf 90% CI was 0.9542-1.1343. Therefore both test and reference drug was fairly tolerated by volunteers and no adverse event was
detected. Hence, the average ratio of 90% confidence interval of AUCo-t and AUCO-inf was
0.9737-1.1150 and 0.9542-1.1343 that lie within the acceptable limit of (0.80 - 1.25) for
bioequivalence acceptance. Effectiveness of deferiprone depends on AUC instead of Cmax therefore the average ratio of 90% confidence interval of Cmax was 0.9876-1.3125 that lie
with the acceptable limit of WHO bioequivalence acceptance (0.75 - 1.33). ANOVA show
no significant variations among drug, period and sequence effect. Therefore, it was concluded
that Ferriprox was proved to be bioequivalent in healthy male Pakistani volunleers.
Availability: Items available for loan: UVAS Library [Call number: 1327,T] (1).
3.
Comparative Pharmacokinetics Of Silymarin In Healthy Male And Female Volunteers
by Farah Abid | Prof.Dr.Muhammad Ashraf | Dr. Mateen | Dr. Sualeha Riffat.
Material type: ; Format:
print
; Nature of contents: ; Literary form: Publisher: 2011Dissertation note: The study was designed to compare the pharmacokinetic parameters of Silymarin in 8
healthy male and 8 healthy female volunteers. Only those healthy volunteers were
selected who were of age between 18-45 years, not having any disease. Female's
volunteers were also of age of 18-45 years and also who were not pregnant and also not
suffering from any disease.
Written consent form were taken from the volunteer and they were thoroughly
inform about the study and objectives of study ,frequency of blood sampling, and any
other side effects linked to the drug which they might having during the study.
Volunteers were divided into two groups A and B respectively. Both groups
were given silymarin 200mg dose per oral to each individua1.5ml of blood samples were
drawn after different time interval .5 ,1,2,3,5,8 and 12 hr from the vein through 5ml BD
syringes of 22 gauge needle after oral administration of silymarin.
Plasma were separated by centrifugation at 5000 RPM and stored at -40 C till
analysis. Silymarin concentration in plasma was determined by using HPLC method. All
pharmacokinetics parameter were determined by entering the plasma concentration time
data in software APO pharmacological analysis .Then pharmacological parameters in
healthy male and healthy females were compared. Result showed that pharmacokinetic
parameters are significant & those parameters were AVC, Tmax, t1l2 & CI. This result
showed that there is a significant relationship between healthy male & female.
Availability: Items available for loan: UVAS Library [Call number: 1329,T] (1).
4.
Bioequivalence Study Of Atorvastatin Tablets In Human Volunteers
by Asif Ali Bokhari | Dr. Sualeha Riffat | Prpf. Dr. Muhammad Ashraf.
Material type: ; Format:
print
Publisher: 2012Dissertation note: Main purpose of this clinical trail was to evaluate bioequivalence parameters of two generic drug products. It was a randomized, single dose, two-period crossover trial. Study was done on 12 volunteers with the age limit of 18-45yrs. Inclusion and exclusion criteria was used for volunteers selection and the study conducted with two week washout period. Each volunteer received one tablet of atorvastatin (reference or test) 10mg. Almost 13 blood samples of 5ml were collected at predefined time intervals. Blood samples were collected in heparinized vacuette. Blood was centrifuged after sampling and stored at -80°C till analysis. Serum atorvastatin levels were examined by using high performance liquid chromatography (HPLC) method mobile phase was a mixture of Sodium di-hydrogen phosphate buffer and acetonitrile 65:35 v/v pumped at flow rate of 1ml/min at a wavelength of 260nm. Two compartmental analysis was used for evaluating bioequivalence parameters to evaluate the both drugs were bioequivalent or not .2 major parameters of bioequivalencepeak plasma concentration Cmax and area under the curve AUC 0-t were evaluated. By statistical analysis, 90% confidence interval for area under the curve AUC 0-t was found to be 0.5972 - 1.7093, it was not within the range (0.80 - 1.25) proving an in equivalence between the two products so it shows that area under the curve AUC 0-t for both drugs is not equivalent. By statistical analysis, 90% confidence interval for peak plasma concentration Cmax found to be 0.3840 - 3.6638., it was not within the range (0.80 - 1.25). So it is evident that peak plasma concentration Cmax for both drugs is not equivalent. So, it was concluded that both of the drugs were not bioequivalent. From the given data, it is concluded that both the drugs produced uncomparable results. So it can be concluded that Lipiget cannot be used in replacement of Lipitor.
Availability: Items available for loan: UVAS Library [Call number: 1480,T] (1).
