Design and Evaluation of Doxofylline Immediate Release Tablets

Abstract

Doxofylline a bronchodilator and anti-tussive is used for chronic obstructive pulmonary disease (COPD) and asthma that acts as phosphor diesterase inhibitor with minimum cardiovascular side effects due to low affinity foradenosine receptors (both A1 and A2) unlike theophylline and other xanthine derivatives. Doxofylline is water soluble and comes under biopharmaceutical classification class III with high solubility and low permeability. In this study an attempt has been made in development and to evaluate the formulation of Doxofylline tablets of 400mg and these compressed tablets were tested for friability, thickness, disintegration time, hardness, weight variation and assay. The formulation trial F4 was optimized considering the drug release profile and the disintegration time of tablets as they were very close to the reference product values. From this study, it may be concluded that for Doxofylline tablets, F4 stands as a successful formulation and can be manufactured with reproducible characteristics from batch to batch to match the release profile with the reference product. The in-vitro release of Doxofylline tablets was studied in 900 ml of distilled water as dissolution medium using an I.P dissolution paddle assembly at 100rpm and 37±2°C for 45min.