Comparative quality assessment and in vitro dissolution profile of some paracetamol tablet generics marketed in Nigeria

Abstract

Background: Studies have shown an increase in the usage of generic drug products from multiple sources. These generic drugs are expected to satisfy similar established standards as the original or innovator brands. Aim: To assess the standards and interchangeability of six common brands of paracetamol (acetaminophen) tablet generics marketed in Nigeria. Methods: The biopharmaceutical parameters, weight uniformity and assay of active ingredients were carried out according to established methods. The dissolution rates and disintegration times were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. A variation of the concept of dissolution efficiency (DE), known as predicted availability equivalent (PAE), was used to predict the likely in vivo bioavailability. Results: All the brands complied with specifications for the weight uniformity, friability, disintegration time and assay of active ingredient tests. In the dissolution efficiency determination, all the brands released more in SGF than SIF. Conclusion: The study showed that all the six brands of paracetamol tablet tested are interchangeable with one another and thus could be prescribed one in place of the other. This would lead to the reduction in the cost of treatment, increased drug availability and an enhanced patients compliance in the use of acetaminophen tablets. Keywords: Paracetamol, Tablets, Bioequivalence, Interchangeability, Dissolution efficiency, AcetaminophenPort Harcourt Medical Journal Vol. 3 (1) 2008: pp. 85-90