COMPARATIVE BIOAVAILABILITY STUDIES OF PARACETAMOL BRANDS IN HUMANS
COMPARATIVE BIOAVAILABILITY STUDIES OF PARACETAMOL BRANDS IN HUMANS
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Date
2007-05
Authors
MOHAMMED, TIJJANI
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Abstract
The comparative bioavailabilities (bioequivalence) of five generic brands of
paracetamol were compared in six (6) healthy male volunteers. The aim was to study
whether the generic brands are bioequivalent to the standard brand.
The study was carried out following oral administration of 1g of each brand after
wash-out period of two weeks. The concentration of paracetamol in the saliva samples
were determined using UV – spectrophotometer. The pharmacokinetic parameters for
bioavailability evaluation Cmax, Tmax and AUC were determined. The values of
reference tablet panadol® was Cmax 48.50 ± 21.82 μg/ml, Tmax 1 ± 0.41 (hr), AUC
238.13 ± 12.4 μg/ml/hr, while test brand XA was Cmax31.50 ± 16.83 μg/ml, Tmax 0.5 ±
0.25 (hr), AUC 117.93 ± 8.10μg/ml/hr, XB Cmax50.0±17.39μg/ml, Tmax0.50 ±0.25
(hr), AUC 202.0 ± 12.56 μg/ml/hr, XC Cmax42.0 ± 17.39μg/ml, Tmax1 ± 0.41 (hr),
AUC 192.63 ± 10.07μg/ml/hr, XD Cmax50.0 ± 15.82μg/ml, Tmax1±0.41 (hr), AUC
256.13 ±11.51μg/ml/hr and XE Cmax5.3 ± 2.4 μg/ml, Tmax3±1.07 (hr), AUC 27.03 ±
1.34 μg/ml/hr.
Reference ratio of three generic brands XB, XC and XD were bioequivalent
to the standard brand because their limits lies within the bioequivalent range of 0.8 –
1.25 or 80% - 125% confidence limits with panadol® while the other two brands XA
and XE were not within these bioequivalence range with panadol®.
Description
A THESIS SUBMITTED TO THE POSTGRADUATE SCHOOL,
AHMADU BELLO UNIVERSITY, ZARIA IN PARTIAL
FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD
OF THE DEGREE OF MASTER OF SCIENCE IN
PHARMACEUTICAL CHEMISTRY
DEPARTMENT OF PHARMACEUTICAL AND MEDICINAL CHEMISTRY
FACULTY OF PHARMACEUTICAL SCIENCES,
AHMADU BELLO UNIVERSITY, ZARIA – NIGERIA.
Keywords
COMPARATIVE,, BIOAVAILABILITY,, STUDIES,, PARACETAMOL,, BRANDS,, HUMANS