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

max 1 ± “0.41 (hr), AUC

“ max

 

— J max 0.5P± “ O K U

 

K U max

 

$ 8 &

 

ma“x0.50 ±0.25 —

(hr),  AUC  202.0  ± 12.56 — J PmaxO K U max1  ±“; 0.&41  (hr), &

 

$ 8 &

max

 

“ max1±“0.41 (hr), AUC

—

J P—

 

max“

 

max3“±1.07—(hr)J, AUC 2P7.03O±

—

KJ U P

 

 

— J P O K U

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®.