Comparative Study between Paracetamol 500 mg tablets manufactured by Tunisian Teriak laboratories and Paracetamol 500 mg tablets manufactured by England GlaxoSmithKline

Abstract

The study was conducted to determine whether paracetamol tablets manufactured in England GlaxoSmithkliene (GSK) companies and Tunisian Teriak laboratories demonstrate comparable performance when subjected to standard official pharmacopeial quality tests. The evaluations and assessment was done by weight uniformity, friability, disintegration, dissolution, and assay of active ingredient content using UV spectrophotometry in the laboratory. The results shows that products exceeded the minimum requirements set by pharmacopeial standards, Quality control testing included weight uniformity (mean ± SD: GSK tablets = 500.8 ± 2.1 mg; Teriak = 501.3 ± 2.4 mg), friability (0.21 ± 0.02% and 0.24 ± 0.03% for Teriak tablets), disintegration time (3.2 ± 0.4 min and 3.5 ± 0.5 min respectively), dissolution at 30 min (98.5 ± 1.2% and 97.8 ± 1.5%), and assay of active ingredient by UV spectrophotometry (100.2 ± 0.8% and 99.9 ± 0.9%). The results were distinguished in GSK tablets which showed a slightly faster dissolution rate, similarity factor analysis (F2 = 68.4) confirmed equivalence between profiles, both formulations remained well within acceptable limits, indicating that patients can expect equivalent therapeutic efficacy regardless of the country of manufacture.