Design, Development and In-Vitro Evaluation of Floating Bilayer Tablet of Domperidone and Rabeprazole for the Treatment of Gastro Esophageal Reflux Disorder

Bilayer tablets of Domperidone (IR) Rabeprazole (SR) were formulated for the management of gastro esophageal disorder.Immediate layer of Domperidone formulated using Tulsion T-339 as super disintegrant. For sustained release of Rabeprazole HPMC as the rate controlling polymers was used. Preformulation studies were performed prior to compression. The individual layers of the bilayer tablets were evaluated for weight variation, dimension, hardness, friability, drug content, and disintegration time and invitro drug release using USP dissolution apparatus type II (paddle). It was found that the optimized formulation showed 12.8%, 18.0%, 38.8%, 59.5%, 74.9%, 88.5% and 98.9%release for rabeprazole in 0.5,1,2, 4, 6, 8, 12 hours respectively. However, domperidone released 98.28% at the end of 30 minutes. The IR spectrum studies revealed that there is no disturbance in the principal peaks of pure drugs. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. The stability studies were carried out for the optimized batch for three months and it showed acceptable results. The kinetic studies of the formulations revealed that diffusion is the predominant mechanism of drug and release follows first order kinetics.