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. The eradication rate is only 40-55% with the current treatment approach especially in high resistance regions leading to economic burden. The objective of the present work was to develop a novel formulation of gastro retentive drug delivery system (GRDDS) to ensure effective delivery of antibiotics to the gastric mucosa, H.pylori reside.
METHODS: Antibiotics that were used in the first line treatment were formulated into GRDDS beads using the ion-gelation technique. Gastric residence time and efficacy of the formulation evaluated in both in vitro and in-vivo animal models.
RESULTS: In vivo imaging studies demonstrated a gastric residence time of up to 8h for the GRDDS formulation. The mucosal bioavailability study also showed an enhanced bioavailability as expected in our hypothesis. 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.