COMPARATIVE BIOAVAILABILITY STUDIES OF PARACETAMOL BRANDS IN HUMANS

COMPARATIVE BIOAVAILABILITY STUDIES OF PARACETAMOL BRANDS IN HUMANS

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®.

COMPARATIVE BIOAVAILABILITY STUDIES OF PARACETAMOL BRANDS IN HUMANS