Pharmaceutical equivalence studies on some locally manufactured brands of paracetamol sold in Kumasi.

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August, 2016
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Paracetamol (acetaminophen), N-(4-Hydroxyphenil)-acetamide an over-the-counter analgesic, antipyretic and anti-inflammatory drug is a widely used drug. There are numerous generics of Paracetamol tablets available within the health delivery system in Ghana and globally. This study sought to determine the pharmaceutical equivalences between some selected brands of Paracetamol produced locally and compared to one imported brand from England. Thirteen brands of Paracetamol tablets plus one imported brand (M&A Pharmachem, England) were purchased from licensed pharmacies within Kumasi. Samples were all immediate-release conventional, oral dosage forms and were coded to avoid bias. Pharmacopoeial and non-pharmacopoeial tests such as 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 the various brands of Paracetamol tablets. The paddle method was used for the dissolution testing. UV spectroscopy was used for the assay analysis of all the brands of Paracetamol tablets sampled. All brands complied with the official specifications for identification, diameter, thickness and hardness. PLE, PMA, PPH, and POC passed all the test conducted on it. However brands PSA, PTA and PDA passed majority of the tests and failed the test for assay. 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 are different from the standard in at least one test. Only Brands PLE, PPH and POC are pharmaceutically equivalent to the standard (PMA) and may be used as alternatives if they proved to be bioequivalent.
A thesis submitted to the School of Graduate Studies in partial fulfilment of the requirements for the degree of Master of Science in Pharmaceutical Technology,