Vol 14, Issue 9, 2021 Online - 2455-3891 Print - 0974-2441 FORMULATION AND EVALUATION OF FLOATING IN SITU GEL OF OMEPRAZOLE MAGNESIUM FOR ORAL DRUG DELIVERY SYSTEM ANKIT SONI*, MAHESH KUMAR KATARIA Department of Pharmaceutics, Seth G. L. Bihani S. D. College of Technical Education, Gagan Path, Sri Ganganagar, Rajasthan, India. Email: pharmacy.ankitsoni@gmail.com Received: 30 May 2021, Revised and Accepted: 05 July 2021 ABSTRACT Objective: Omeprazole magnesium is indicated for the treatment of erosive esophagitis associated with gastroesophageal reflux disease. It is one of the highly prescribed proton pump inhibitor in the management of peptic ulcer diseases. The therapeutic concentration of a drug in blood can be maintained for a prolonged period of time by administering it in the form of in situ floating gel dosage form. Omeprazole magnesium undergoes degradation at a low pH of the esophagus and stomach; it is therefore given as in situ gel, so, there is minimum contact with acidic pH. Methods: Omeprazole magnesium suspension prepared using various polymers and floating agents in varying concentrations. Several evaluation tests including dissolution test to ensure the release of the drug from formulation by in vitro technique, color and homogeneity, in vitro floating duration, in vitro gelling capacity, drug content determination, pH of the formulation, and floating lag time were studied. Results: All formulations demonstrated good Fourier-transform infrared compliance and no interaction between drug, polymer, and other excipients. The study’s findings show that the formulation F6 showed the best results. Conclusion: The developed formulation was a viable alternative conventional solution by virtue of its ability to enhance bioavailability through its longer gastric residence time and ability to sustain drug release as well as the advantage of floating and pH which minimize the degradation of omeprazole magnesium which is easily degraded by acidic environment. Keywords: In situ gel, Gastroesophageal reflux disease, omeprazole magnesium, Polymers, In vitro floating duration, In vitro gelling capacity bioavailability, Gastric resident time. INTRODUCTION Floating systems are low-density systems with sufficient buoyancy to float over the gastric contents without affecting the gastric emptying rate for a prolonged period of time. While the system is floating on the gastric contents, the drug is released slowly at the desired rate from the system [1]. Floating system results in an increased gastric retention time and a better control of the fluctuations in plasma drug concentration. Minimal gastric content is required to allow proper achievement of the buoyancy retention principle and a minimal level of floating force (F) is also required to keep the dosage form reliably buoyant on the surface of the meal. Formulation of gastro retentive in situ gel system involves the use of gelling agent which can form a stable sol/suspension system to contain the dispersed drug and other excipients. The gelling of this sol/suspension system is achieved in gastric environment, triggered by ionic complexation due to change in pH [2]. Gastroesophageal reflux is the involuntary movement of gastric contents to the esophagus (Fig. 1). Gastroesophageal reflux is a normal physiological process that occurs several times a day without symptoms or damage of the esophageal mucosa in most otherwise healthy individuals. Gastroesophageal reflux disease is a condition in which reflux of gastric contents into the esophagus produces frequent or severe symptoms that negatively affect the individual’s quality of life or result in damage to esophagus, pharynx, or the respiratory tract [3]. Omeprazole magnesium (Fig. 2) is a benzimidazole with selective and reversible proton pump inhibition activity. It forms a stable disulfide bond with the sulfhydryl group of the hydrogen-potassium (H+ - K+) ATPase found on the secretory surface of parietal cells, thereby inhibiting the final transport of hydrogen ions (through exchange with potassium ions) into the gastric lumen and suppressing gastric acid secretion [4]. METHODS Omeprazole magnesium was kindly provided by Dr Reddy’s Laboratories, Hyderabad, sodium carbonate sodium alginate, methyl paraben, and propyl paraben were procured from Arora and company, Delhi, Sodium citrate and Hydrochloric Acid form Central Drug House (P) Ltd., New Delhi, Calcium chloride from Loba Chemicals, Mumbai. All chemical and reagents used were of analytical grade. De-ionized water was used for the complete study. Preformulation studies Preformulation studies required to ensure the development of a stable as well as therapeutically effective and safe dosage form. These studies focus on the physicochemical properties of the drug that could affect performance and development of an efficacious dosage form. Description of drug Organoleptic properties of drug, that is, color, odor, and taste were observed. Identification of drug • UV spectrophotometric analysis of drug Ultraviolet absorption in the range 200–400 nm of a 100 μg/ml solution of the drug in 0.1 N HCl was determined [5]. • Fourier-transform infrared (FTIR) analysis of drugs © 2021 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/ licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ajpcr.2021v14i9.42231. Journal homepage: https://innovareacademics.in/journals/index.php/ajpcr Research Article