Abstract

*M. Anushiya, Dr. G. Selvi, V. Deepa Kumari and R. Priya Darshini

ABSTRACT

A novel triple therapy comprising of an antibiotic, anti-ulcer drug and a prostaglandin analogue in modified release dose form that would be an effective treatment for eradication of h. pylori infection. Considering bilayer tablet technology as a representation for drug delivery system, Misoprostol, Metronidazole and Esomeprazole were chosen as model drugs for the current study. Initially the process variables like concentration of the super disintegrates Crospovidone, sodium starch glycolate, cross carmellose sodium in immediate release layer, polymers HPMC K15M and carbopal, Xanthan gum in sustained layer were tablets formulated by direct compression technique. FTIR studies indicated that the drug is compatible with all the excipients the standard calibration curves for Misoprostol, Metronidazole and Esomeprazole were plotted by UV spectrometer individually. The physical mixtures of both the layers were evaluated for pre compression parameters. Tablets were prepared by direct compression technique. Post compression parameters weight variation, hardness, friability assay and dissolution profile were carried out which were within the limits. The immediate release layer of the bilayer tablet releases within 45min and other layer sustains for 12 hrs. And release 98% of drug. The results of the release kinetics study for SR layer indicates that the First order Kinetics (R2 0.900-0.9750) and it fit into higuchi‘s model (R2 0.920 - 0.989). The bilayer tablets were subjected to short term stability study as per ICH guidelines. The data for stability studies revealed that no considerable differences in physical and chemical parameters. The proposed triple therapy with bimodal release of three drugs could prove an effective treatment strategy for h. pylori infection in which the Misoprostol reduces the inflammation and pain, Metronidazole inhibits the bacterial growth and Esomeprazole supresses the acid secretion in stomach.