Formulation and Evaluation of Bilayer Tablets of Diclofrenac Sodium with Ranitidine HCL for Sustained and Immediate Release

Abstract

The aim of present study is to formulate and evaluate the bilayered tablets containing Diclofenac Sodium in the sustained release (SR) portion and Ranitidine HCl in the immediate release (IR) portion in order to produce a single tablet containing two different classes of drugs as widely prescribed by doctors and to have better patient compliance.The sustained release layer of Diclofenac Sodium was prepared by using different grades of HPMC like, HPMC E15, HPMC K4M, K100M, and Ethyl Cellulose with cross carmellose along with other excipients like Magnesium stearate, Microcrystalline cellulose & PVP by wet granulation technique. The Immediate release layer of Ranitidine Hcl was prepared by direct compression Method. The powders were evaluated for their flow properties and the finished tablets were evaluated for their physical parameters. The drug release study of Ranitidine HCl and Diclofenac Sodium were evaluated using USP-XXII paddle type dissolution apparatus. The release rate of Ranitidine HCl was studied for 45 min using water as media and that of Diclofenac Sodium was studied for 2 h in 1.2pH buffer followed by 6 h in pH 6.8 phosphate buffer media using a developed HPLC method. The release rate of ranitidine HCl from all the formulations was more than 80% at 45 min. In case of HPMC E15, HPMC K4M, K100M based tablets with the increasing of polymer content the release mechanism moved to super case. Total four trial batches of each drug have been manufactured to optimize and develop a robust and stable formulation, the stability studies of the products also comply with ICH guidelines.