Development and evaluation of formulations for h Pylori infection management

Abstract

H. Pylori gram negative bacteria spread over the world is a main causative pathogen for gastritis leading to gastric cancer. Infection requires complicated treatment of combination of antibiotics with proton pump inhibitor to be given three to four times a day for 7 to 14 days which reduces patient compliances as well sequential dosing increases manufacturing and packing cost. Further organism resides deep inside the mucosal layer so for better eradication needs site specific delivery of the drugs. Aim of the research work was to develop single unit dosage form like capsule or tablet containing combination of or Metronidazole and Lansoprazole in different dosage forms like triple layer tablet , multiparticulate system containing enteric coated Lansoprazole granules and floating alginate beads of Metronidazole and gastro retentive sandwich patch with Lansoprazole enteric coated granules using different semi-synthetic or synthetic polymers. Formulations were evaluated for required in-vitro studies like hardness, friability, Floating lag time, mucoadhesion and dissolution study etc for triple layer tablet while floating time, mucoadhesion , particle size, swelling index, % entrapment for multiparticulate dosage form and folding endurance, tensile strength, dissolution profile for expandable patch of Metronidazole along with enteric coated granules of Lansoprazole to determine their efficacy for management of H. Pylori infection. Work also includes development and validation of simultaneous analytical method for determination of Metronidazole and Lansoprazole using RP-HPLC according to ICH guidelines. After comparing all three formulations it was observed that research work had achieved mentioned objectives of reducing number of dosage forms to increase patient compliance as well as enhance efficacy of the formulation by specific drug delivery to stomach by developing and optimising triple layer tablet containing Metronidazole and Lansoprazole together. Present research work will further surely help in reducing