In Vitro Dissolution Profiling of Two marketed Paracetamol Tablets

Abstract

The present study aimed to compare the in vitro dissolution profiles of two commercially available paracetamol tablet brands, Innovator Drug 1 and Innovator Drug 2, each containing 500 mg of the active pharmaceutical ingredient. Despite having the same strength and therapeutic purpose, variations in excipients and manufacturing processes can affect the rate and extent of drug release, directly influencing bioavailability and therapeutic efficacy. The dissolution testing was conducted using USP Apparatus II (Paddle method) in phosphate buffer (pH 5.5) at 37 ± 0.5°C with a paddle rotation speed of 50 rpm. Drug release was measured spectrophotometrically at predetermined intervals over 60 minutes. The results demonstrated that while both formulations released the drug progressively, Innovator Drug 2 exhibited a significantly faster and more complete dissolution profile than Innovator Drug 1 at all-time points. At 60 minutes, Innovator Drug 2 achieved 98.28% release compared to 93.62% by Innovator Drug 1. These differences may be attributed to disparities in excipient composition or disintegration efficiency.

This comparative analysis highlights the importance of dissolution testing as a quality control tool and supports its role in assessing product equivalence and guiding therapeutic substitution decisions. The findings may inform regulatory evaluations and ensure consistency in clinical performance among marketed formulations.