FORMULATION AND EVALUATION OF CLARITHROMYCIN EXTENDED RELEASE TABLET

The design of extended release tablet by using natural polymers are becoming very popular in formulating oral controlled release tablet as they are biocompatible, biodegradable, non-toxic, cheap and easily available compared to synthetic polymers. The present investigation was planned to formulate and evaluate the clarithromycin once daily extended release tablets with natural polymers like guar gum and xanthan gum and in combination with HPMC K15M. Drug- excipient compatibility study was conducted using FTIR spectroscopy. A total of seven formulations were prepared with different combinations of polymers using wet granulation and compression method. Pre compression and post compression parameters were tested and in vitro drug release study was performed and the data were fitted into kinetic models. The selected best formulation (F7) was kept for short-term accelerated stability studies (1 month at 40oC±2oC / 75%±5% RH). FTIR analysis of spectra showed that there are no drug-excipients interactions and all the formulated tablets had acceptable physical properties. Drug content uniformity, hardness and thickness of best formulation (F7) were found to be 99.7±0.004%, 4.8±0.21 Kg/cm2 and 4.9±0.002mm. Formulation (F7) showed release up to 94.81% in 0.1 N HCl and 88.4% in potassium phosphate buffer pH 6 in 24 hrs. The release mechanism of the best formulation (F7) was found to be non fickian and Fick’s law respectively, i.e., by both diffusion and erosion. It can be concluded that a successful once daily extended release tablets of Clarithromycin have been prepared by using the natural polymer such as guar gum.