Abstract

FORMULATION AND EVALUATION OF BILAYER TABLETS OF A NSAID AS AN IMMEDIATE RELEASE LAYER AND SUSTAINED RELEASE LAYER

Swetha Gadhe*, Ashwini Rajendra, Kishori patel

Abstract

The objective of the present study was to develop a bilayer tablet of Indomethacin by using bilayer tablet technology. Immediate release layer of Indomethacin was prepared by using crospovidone, mannitol and microcrystalline cellulose. Sustained release layer of Indomethacin was prepared by using polymers such as HPMC K4M and guar gum in different concentration ratios of [1:1], [1:0.75] & [1:0.5]. FT-IR studies revealed that there was no interaction between the drug and polymers used in the study. Tablets were evaluated for post compression parameters. In vitro dissolution studies were carried out using USP type II (Paddle) type apparatus using phosphate buffer pH 7.4 as a dissolution medium. In the formulations F4 & F5 drug release was found to be 90.89±0.99% & 84.43±0.38% respectively. The in vitro drug release data were fitted into kinetic models. It was found that the formulations F4 & F5 followed zero order kinetics. Release exponent for formulations F4 & F5 were found to be 0.279 & 0.290 respectively and thus drug release followed fickian diffusion mechanism. MDT and %DE for formulations F4 & F5 was found to be 2.6192hrs &2.8343hrs and 70.8971% & 68.5067% respectively. Selected formulations F4 & F5 showed less variation in stability studies when stored at 40 ± 2°C / 75 ± 5 % RH for 2 months. In this study the formulations F4 & F5 released the drug upto 24hrs and hence can be used for extending the drug release.

Keywords: Indomethacin, Crosspovidone, HPMC K4M, Bilayer.