Effects Of Storage Conditions On Pharmacokinetics Of Paracetamol Tablets

Twenty (20) Hospitals/Clinics, thirty (30) registered Pharmacy shops and onehundred and twenty five (125) Patent medicine stores were screened for their storagefacilities in Zaria areas. Two of each of drug storage areas with sub optimum storagefacilities (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 thenselected for the study. The average consumption rate of 1000 tablets per month wasobtained in these areas screened. The paracetamol tablets used were stored for twomonths in these areas. Samples taken before exposure (controls) and after two monthsexposure (test samples) for in vivo studies. The brand of paracetamol used passed allquality control analyses.Twelve (12) healthy young adult male volunteers with average age of 27.67 yearsand average weight of 66.67 kg took part in the study. Each volunteer was administered 1g 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 plasmaconcentrations determination. Student t-test table was used to compare tests results tocontrol for data analysis. P value less than 0.05 is significant.Blood levels derived from tablets obtains from the storage areas fitted to first orderkinetics. 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 plasmalevels (tmax) remains the same in all the storage areas and is 0.33 hr (20 mins.) Areas underthe 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 tocontrols, since the differences in their relative bioavailabilities satisfied the standardrequirement of not more than 25%.The sub optimum conditions have shown variable kinetics of other parameters suchas volume of distribution, plasma clearance, absorption and elimination rate constants, lagtime, elimination and absorption half lives. These differences could be due to individualvariations as shown in other similar works. This study has therefore shown that thesestorage conditions have no significant effect on the pharmacokinetics of paracetamoltablets.

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