BIOAVAILABILITY AND PHARMACOKINETIC STUDIES OF BRANDS OF PARACETAMOL DOSAGE FORMS

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BIOAVAILABILITY AND PHARMACOKINETIC STUDIES OF BRANDS OF PARACETAMOL DOSAGE FORMS

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.

BIOAVAILABILITY AND PHARMACOKINETIC STUDIES OF BRANDS OF PARACETAMOL DOSAGE FORMS

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