STUDIES ON THE EFFECT OF pH OVER DISSOLUTION PROFILE OF DICLOFENAC SODIUM SUSTAINED RELEASE TABLETS

Abstract

The present study was performed to illustrate the effect of pH on dissolution profile of diclofenac sodium sustained release tablets. Diclofenac sodium has analgesic, antipyretic and anti- inflammatory activities. It is a potent relatively non-selective cyclooxygenase inhibitor. It is absorbed rapidly and completely after oral administration; peak Concentrations in plasma reached within 2-3 hours. The drug extensively binds to plasma proteins (99%) and its half- life in plasma is 1-2 hours. Diclofenac sodium extended release tablets are prescribed for long-term symptomatic treatment of Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Dissolution studies in different pH mediums were performed to mimic the in-vivo condition by doing in-vitro tests. The pH/buffer selection bases on the exposure of drug from stomach to intestine/colon and ensures the impact of pH changes on dissolution and release of drug substance for absorption. The study ensures the impact of pH changes on dissolution and release of drug substance for absorption.