Gastroretentive delivery system of clarithromycin and proton pump inhibitor using different polymers for helicobactor pylori infection

Abstract

Introduction Floating drug delivery system (FDDS) is one of gastroretentive dosage forms which could prolong GRT to obtain sufficient drug bioavailability. It is useful for drugs that act in the proximal part of gastrointestinal tract such as antibiotic administration for Helicobacter pylori eradication. The system floats in the gastric fluid because of its lower bulk density. Objectives The main objectives of the present studies are listed below: A. To develop a stomach specific multiple unit particulate formulation of clarithromycin, this floats in the stomach, for long time by the principle of buoyancy and releases the antibiotic for longer period of time. It was also proposed to enhance the efficacy of clarithromycin by providing less degradation in the acidic environment by proton pump inhibition by pantoprazole. B. To formulate a Eudragit S100 enteric coated pantoprazole sodium sesquihydrate, a proton pump inhibitor formulations using mainly natural polymers such as sodium alginate and low methoxy pectin.It was also planned to evaluate the formulation in vitro for its physicochemical properties including the drug release characteristics in the alkaline pH and final selection of the best formulation. Optimization and evaluation I. To effectively utilize the 32 full factorial design tool for development and optimization of both clarithromycin and pantoprazole formulations. II. To study the enhancement of CL concentration in situ by the formulation of PSS using wistar rats. III. To study the gastroretentive property of CL formulation for better efficacy by in situ gastro retention studies in wistar rats. IV. To study the pharmacokinetics of clarithromycin and pantoprazole from the formulations using albino rabbits.Materaials and methods Clarithromycin, Pantoprazole sodium sesquihydrate, chitosan, sodium alginate, pectin (LM) were used for the formulations.