BIOAVAILABILITY AND PHARMACOKINETIC STUDIES OF BRANDS OF PARACETAMOL DOSAGE FORMS
BIOAVAILABILITY AND PHARMACOKINETIC STUDIES OF BRANDS OF PARACETAMOL DOSAGE FORMS
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Date
1987-07
Authors
BAKARE, MOJIRADE TAIBAT
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Abstract
Total drug content for thirteen different
brands of paracetamol tablets and five brands of
paracetamol syrup has been evaluated.
Chemical assay methods based on colorimetric
and spectrophotometric absorption were employed in
the study. The results (except for one brand of
paracetamol syrup) complied favourably with the
stated amount in the monogram for paracetamol
content (95.0 - (5.0)%. The exceptional
paracetamol syrup (S2) was found to contain 89.12%
of the labelled amount of paracetamol.
Dissolution rate profile of thirteen different
lots of paracetamol tablets in 0. 1M HC1 solution
was investigated by means of U.S.P. XVIII rotating
basket method. The drugs showed some similarities
as well as some differences in their respective
dissolution rate profiles. The differences
observed in the dissolution rates of the drugs
were probably due to the different manufacturing
processes employed by the different manufacturers.
Disintegration time test was carried out on
three brands of paracetamol tablets (Al, A2 and
A7) . There was considerable variation in their
disintegration times which could be due to
different types and amount of disintegrant used by
the different manufacturers.
In vivo bioavailability study of some brands
of paracetamol tablets was carried out in healthy
human subjects. A simple, reliable and rapid
method of paracetamol estimation, developed by
Glynn and Kendal (1975), was adapted for the
determination of serum and saliva paracetamol
levels. Serum and saliva paracetamol half-lives
were calculated by the method of residuals. Area
under the concentretion-time curve <AUC> was
calculated by the trapezoidal rule and
extrapolation to infinity.
Higher but statistically insignificant, levels
of paracetamol were detected in saliva compared
with the serum for the first 60 minutes following
oral ingestion of lg of the drug. There was a good
linear correlation between the concentration of
paracetamol in serum and saliva. One of the
products (A7) was verv slowly absorbed, consistent
with its low dissolution rate found in vitro.
Paracetamol elimination half-lives calculated for
serum and saliva were similar.
The in vivo data quantitatively correlated
with the in vitro release of these tablets.
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.
JULY, 1987
Keywords
BIOAVAILABILITY,, PHARMACOKINETIC,, STUDIES,, BRANDS,, PARACETAMOL,, DOSAGE,, FORMS.