Bioavailability studies on a locally manufactured paracetamol tablet.
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Date
2002-12-12
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Abstract
Bioavailability studies using urinary excretory data have been carried out. Paracetamol tablets from a Ghanaian Pharmaceutical Manufacturing Company were adequately identified quantified and their pharmaceutical equivalence with respect to a reference established. The fraction of dose excreted unchanged in urine by the test and reference samples, and the Relative Bioavailability of the test sample was determined using a crossover design.
1 000mg each of the test and reference samples were administered to the subjects in a lasting state, with a washout period of one week between drug administrations. Urine samples were collected and analysed at specified time intervals, spanning 24 hours. The analytical method employed was RP-LC with a stationary phase of Spherisord S5ODS I Phase Sep column and a mobile phase combination of Methanol, Water nd Glacial Acetic Acid in the ratio: 2$: 69: 3 respectively. Column eluate was monitored at 236nm
a U V detector. The analysis was conducted at an ambient temperature with a flow rate of l.5ml/min. and 0.5AUFS.
The mean percentage amounts of paracetamol excreted unchanged in urine was found to be 10.521 % and 10.691% 1br the test and reference samples respectively. The Relative Bioavailability of the test sample was found to be 98.41 % which is within the WI l( range of 80% to 1 25%. The determined means and standard deviations were statistical l compared and found not to differ significantly.
The test and reference samples were found to be pharmaceutically equivalent, Bioequivalent and therapeutically equivalent. They are therefore interchangeable for therapeutic purposes.
Description
A thesis submitted to the Department of Pharmaceutical Chemistry, School of Medical Sciences, College of Health Sciences,
Kwame Nkrumah University of Science and Technology in partial
fulfilment of the requirements for the award of Master of Science, 2002