Abstract

FORMULATION AND EVALUATION OF BILAYER TABLETS OF SUSTAINED RELEASE NSAID’s AND IMMEDIATE RELEASE PROTON PUMP INHIBITOR

Kishori Patel* Ashwini Rajendra and Swetha Gadhe

Abstract

Aim of the present work was to develop bi-layer tablets of Esomeprazole (IR) and Diclofenac sodium (SR) using bi-layer technique. Esomeprazole immediate release layer was prepared by using crospovidone, starch and microcrystalline cellulose. Diclofenac sodium sustained release layer was prepared by using polymers such as methocel K15M and guar gum in the ratio of [1:0.5]. The drug and polymers were subjected for the compatibility studies using FT-IR which indicated no interaction had taken place between the drug and polymers. The pre-compression parameters and the post-compression parameters of formulations were evaluated. The drug release studies of Esomeprazole [IR] layer were performed in 0.1N HCl for 120 min and Diclofenac sodium [SR] layer were performed in phosphate buffer pH 6.8 for 9 hrs. Formulations F2 and F3 showed satisfactory % drug release among the prepared formulations. In formulation F2, % drug release of Esomeprazole was 99.801±0.52% and % drug release of Diclofenac sodium was 75.474±0.66%. In formulation F3, % drug release of Esomeprazole was 99.461±0.88% and %drug release of Diclofenac sodium was 71.275±2.14%. The in vitro drug release data was fitted in kinetic models. It was found that all the formulations followed zero order kinetics and non-Fickian/Anomalous diffusion mechanism. MDT and %DE for formulations F2 and F3 were found to be 4.64hr & 4.64hr and 48.37% & 48.40% respectively. From stability studies (at room temperature and at 40±2°C/75±5%RH for 2months), it was found that selected formulations F2 and F3 were stable during study period.

Keywords: Bi-layer tablets, Diclofenac sodium, Esomeprazole, Crospovidone, HPMC K15M, Guar gum, Wet granulation.