OBJECTIVES:Paracetamol, N-(4-Hydroxyphenil)-acetamide, an over-the-counter analgesic and antipyretic agent is a widely used medicine, with numerous generics. However the sustainability of quality, efficacy and safely leaves much to be desired.This study sought to determine the pharmaceutical equivalence between selected locally produced brands of Paracetamol tablets and an innovator brand from England.

METHODS:Thirteen brands of Paracetamol tablets plus an innovator brand coded PMA were purchased from licensed Pharmacies within Kumasi. All samples were immediate-release conventional, oral dosage forms, coded to avoid bias. Pharmacopoeia and non-pharmacopoeia tests including friability, thickness, hardness, uniformity of diameter, uniformity of weight, disintegration time, in vitro dissolution testing and assay were used to assess the pharmaceutical equivalence of all the brands. The paddle method was used for the dissolution testing while using UV-vis spectroscopy for the assay of the sampled brands of Paracetamol tablets

RESULTS :All brands complied with the official specifications for identification, diameter, thickness and hardness. However only PMA with PLE, PPH, and POC (locally produced) passed all the tests. Brands PSA, PTA and PDA on the other hand failed the test for assay while passing the rest of the tests. Furthermore, brands PAS, PMG and PAN failed the dissolution rate test and assay. Brand PKI also failed the test for disintegration and dissolution. PAE failed the weight uniformity test but passed the other tests. PAR performed poorly by failing the test for friability, weight uniformity and assay. Statistically, all brands were found to be different from the innovator brand in at least one test.

CONCLUSIONS :Only three brands (PLE, PPH and POC) representing 23% of tablets analysed were pharmaceutically equivalent to the innovator brand (PMA) and may be used as alternatives if they proved to be bioequivalent. Ghanaians stand a great risk of using Paracetamol tablets that are substandard.