Formulation and Characterization of Floating Tablet of Esomeprazole Magnesium Trihydrate

Abstract

Background: Esomeprazole is a protein pump inhibitor (PPI) prescribed to treat acute duodenal ulcers, acute benign gastric ulcers, gastroesophageal reflux disease (GERD), and to prevent duodenal ulcers. It exerts a local effect on the stomach and operates by competitively blocking the H+/K+ ATP enzyme, which is present in gastric parietal cells. Aim: The aim is to formulate and evaluate floating tablets of esomeprazole magnesium trihydrate. Objective: The current work aims to build a reproducible and robust process for formulating proton pump inhibitors and anti-ulcer drugs. Method: The current endeavor to make floating tablets uses the direct compression method. The Esomeprazole Magnesium Trihydrate, sodium bicarbonate, citric acid, Avicel 102, and HPMC K15, Lactose, PVP K30 were sieved through sieve no. 60 and blended uniformly with a mortar and pestle. Using a Rotary tablet punch machine, the powder was compacted into tablets after talc and magnesium stearate were added as lubricants. Results and Discussion: The compatibility between drug and excipients was assessed by Fourier transform infrared (FTIR) spectroscopy. The prepared tablets were evaluated for different parameters such as hardness, friability, drug content, floating time, in vitro dissolution, and stability. Optimized batch F9 is further studied for FTIR, DSC, and Stability study as per standard ICH Guidelines.