Bioequivalence study on Some Commercially Available Paracetamol Tablets with the innovator product: In vitro dissolution study

Abstract

Dissolution testing is a crucial in vitro technique in the formulation and development of pharmaceutical dosage forms. Tablets, a common dosage form, consist of a mixture of active ingredient(s), usually in powder form, with or without excipients. Acetaminophen is one of the most widely used drugs in the world. Numerous brands of acetaminophen are available commercially which are widely considered bioequivalent. The aim of the current study was to conduct a dissolution test on various products of acetaminophen tablets to assess their bioequivalence. Five different generic formulations of 500 mg paracetamol tablets from different manufacturers were selected and tested for dissolution in a 5.8 pH phosphate buffer for 30 
minutes. 
Results were compared to those obtained from the reference product using a USP Type II dissolution testing apparatus. The dissolution testing revealed that products A, B, C, D, and E have dissolution rates of 96%, 103%, 114%, 111% and 94%, respectively, in comparison to the brand Panadol, which dissolved at 99% within 30 minutes. All tested tablets were within the pharmacopoeia criteria.