Presentation (CTI)

OBJECTIVES: H.pylori affects 50% of world population and is prevalent in developing countries. The infection leads to peptic ulcer disease and gastric cancer. Its management is a challenge for the treating doctor because of the ineffective treatment regimens, antibiotic resistance and relapse. The eradication rate is only 40-55% with the current treatment approach. The objective of the present work, was to develop a novel formulation of gastro retentive drug delivery system (GRDDS) to achieve effective delivery of antibiotics to achieve higher eradication rate of the organism.
METHODS: Antibiotics that were used in the first line treatment were formulated into GRDDS beads using the ion-gelation technique. Formulation was characterized using XRD, FTIR, SEM and DSC techniques. Efficacy of the formulation was evaluated using CFU count determination, biochemical evaluation and histopathology analysis on the stomach tissue of treated SD rats.
RESULTS: Efficacy of the formulation evaluated in in-vivo animal models confirmed that there was significant reduction in the colony forming units (CFU) in rats treated with the GRDDS formulation compared to those rats treated with the free drug. The results of biochemical evaluation, gene expression studies and histopathology further proved the superior efficacy of the formulation in curing the disease.
CONCLUSIONS: The in vivo efficacy evaluation showed a 2.1-fold increase in efficiency compared to standard treatment. This GRDDS-mediated two-fold increase in efficacy translates to an eradication success to 85-95%, fulfilling the Maastricht VI/Florence Consensus ≥90% threshold for effective therapy of H.pylory. A clinical study needs to be conducted to evaluate the dosage and efficacy so that a cost benefit evaluation could be determined considering the disease burden related to the infection and related complications like peptic ulcer disease and gastric cancer.