EFFECTS OF STORAGE CONDITIONS ON PHARMACOKINETICS OF PARACETAMOL TABLETS
EFFECTS OF STORAGE CONDITIONS ON PHARMACOKINETICS OF PARACETAMOL TABLETS
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Date
1999-03
Authors
ZEZI, ABDULKADIR UMAR
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Abstract
Twenty (20) Hospitals/Clinics, thirty (30) registered Pharmacy shops and one
hundred and twenty five (125) Patent medicine stores were screened for their storage
facilities in Zaria areas. Two of each of drug storage areas with sub optimum storage
facilities (lack of functional ceiling fan and air condition, direct sunlight into premises,
cracks in the ceilings and walls, improper ventilation and exposure to dusts) were then
selected for the study. The average consumption rate of 1000 tablets per month was
obtained in these areas screened. The paracetamol tablets used were stored for two
months in these areas. Samples taken before exposure (controls) and after two months
exposure (test samples) for in vivo studies. The brand of paracetamol used passed all
quality control analyses.
Twelve (12) healthy young adult male volunteers with average age of 27.67 years
and average weight of 66.67 kg took part in the study. Each volunteer was administered 1
g of paracetamol tablets orally and blood sampled at 0, 5, 10, 15, 20, 30, 60, 90, 120, 180,
240, 300 and 360 mins.
A reliable, rapid and simple, calorimetric method was used for plasma
concentrations determination. Student t-test table was used to compare tests results to
control for data analysis. P value less than 0.05 is significant.
Blood levels derived from tablets obtains from the storage areas fitted to first order
kinetics. There is statistically significant differences in peak plasma concentrations (P <
0.05) in most areas studied compared to the controls. Time taken to attain peak plasma
levels (tmax) remains the same in all the storage areas and is 0.33 hr (20 mins.) Areas under
the curve from zero to infinity did not show any statistically significant differences (P >
0.05) in most areas studied. There was bioequivalent in all areas studied compared to
controls, since the differences in their relative bioavailabilities satisfied the standard
requirement of not more than 25%.
The sub optimum conditions have shown variable kinetics of other parameters such
as volume of distribution, plasma clearance, absorption and elimination rate constants, lag
time, elimination and absorption half lives. These differences could be due to individual
variations as shown in other similar works. This study has therefore shown that these
storage conditions have no significant effect on the pharmacokinetics of paracetamol
tablets.
Description
A THESIS SUBMITTED TO THE POSTGRADUATE SCHOOL
AHMADU BELLO UNIVERSITY. ZARIA,
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR
THE DEGREE OF MASTER OF SCIENCE IN PHARMACOLOGY
DEPARTMENT OF PHARMACOLOGY AND CLINICAL PHARMACY
FACULTY OF PHARMACEUTICAL SCIENCES
AHMADU BELLO UNIVERSITY ZARIA
MARCH, 1999
Keywords
EFFECTS,, STORAGE,, CONDITIONS,, PHARMACOKINETICS,, PARACETAMOL,, TABLETS