Pharmacotechnical and Chemical Study of Paracetamol Sold in Kinshasa-DR Congo: Comparative Quality Assessment of Five Brands

Abstract

Paracetamol/Acetaminophen was assessed in different 5 brands comparatively to study its physicochemical and pharmaceutical parameters. We also evaluated the similarity among those brands. Widely used as an antipyretic and analgesic agent to cure fever and pain, the therapeutic efficacy of this product depends on both physicochemical and pharmaceutical qualities which include its conformity to standard specifications according to the active ingredient dosage in the formulation. This research work aimed to assess comparatively 5 paracetamol brands tablet form sold in the Democratic Republic of the Congo (particularly in Kinshasa), on their physicochemical and pharmaceutical tests conformities compared to the standard specifications. Based on tests, we evaluated the uniformity of weight, disintegration time, friability, crushing strength (hardness), and the active ingredient dosage per brand. The tests were performed using the SotaxTM apparatus according to standard methods following the pharmacopoeia protocols. And according to the performed tests, only the fifth brand of Paracetamol coded P5 did not satisfy the friability test. About the hardness test, we have also observed the unconformity of three brands (P1, P2, and P3) while both P4 and P5 satisfied the test. This leads us to conclude that among all the studied brands, only P5 satisfy to all the tests either pharmacotechnically or chemically (identification and dosage). And this study allowed us to re-examine the equivalence concept between several princeps (original brand) with their generics since that similarity depends on many parameters that need to be improved during the manufacturing process including in-process analysis in all the phases of preparation to evaluate the rate of either active ingredient or inactive ingredient because each component can affect seriously the final pharmaceutical formulation quality.