1Research Scholar, Department of Pharmaceutics, Dr. Babasaheb Ambedkar Technological University, Pune, Maharashtra, India-412216
2Research Scholar, Department of Pharmaceutics, Savitribai Phule Pune University, Pune, Maharashtra, India-412409
3Assistant Professor, Department of Quality Assurance Techniques, Delight College of Pharmacy, Koregaon Bhima, Pune, Maharashtra, India-412216
Peptic ulcers, Zollinger-Ellison syndrome, and acid-related gastrointestinal illnesses including Gastroesophageal Reflux Disease (GERD) can all be effectively treated with omeprazole, a popular proton pump inhibitor (PPI). Omeprazole's traditional formulation, however, has drawbacks including low bioavailability and quick stomach emptying, which lowers its therapeutic effectiveness. The creation of omeprazole floating tablets has shown promise as a solution to these issues. By providing extended gastric retention and improving drug release at the site of action, these tablets are made to float in the stomach fluid. Omeprazole's controlled, prolonged release from floating tablets improves bioavailability and prolongs therapeutic activity, which may lower dosage frequency and increase patient compliance. Important excipients are utilized to support the floating mechanism and preserve the stability of the medication, such as sodium bicarbonate, hydroxypropyl methylcellulose (HPMC), or other polymers. By minimizing variations in the drug's plasma levels and improving the management of acid-related disorders, this novel dosage form seeks to maximize the pharmacokinetic profile of omeprazole. The current study explores the potential of omeprazole floating tablets to improve the clinical results of acid reflux and other gastrointestinal illnesses by examining their formulation, characterization, and in vitro assessment.
A floating tablet represents a form of gastroretentive drug delivery system (GRDDS) engineered to stay afloat within the gastric environment for prolonged periods. This extended buoyancy facilitates sustained drug release and enhances gastric retention time. The tablet achieves floatation either through the incorporation of low-density polymers or by utilizing gas-generating agents that react upon contact with gastric fluids, ensuring that the dosage form remains suspended in the stomach.1 Omeprazole, a proton pump inhibitor that stops the stomach from creating gastric acid, is often taken as a regular tablet at a dose of 15 mg. Omeprazole has a low water solubility and is chemically labile in an acid environment. Omeprazole has a biological half-life of 1 to 1.2 hours.2
MATERIALS AND METHODS
Omeprazole and Microcrystalline cellulose PH 102 was obtained as gift sample from Murli krishna Pharma Pvt. Lit. Ranjangoan, HPMC K 4 M, HPMC K 15 M, PVP K 30, was obtained from Sharadchandra Pawar College of Pharmacy Dumbarwadi, Otur, Pune, Maharastra, India- 412409. Sodium Bicarbonate, Citric Acid, Magnesium stearate, Talc was obtained from Delight College of Pharmacy, Koregaon Bhima, Pune, Maharastra, India- 412216.
Preparation of Omeprazole Tablet
Step 1: Solution Preparation
Dissolved Required Quantity of PVP K30 and Omeprazole API completely in water to make a clear solution by using mechanical stirrer.
Step 2: Dry Mixing
Sodium bicarbonate, Citric acid, Magnesium stearate, Talc, MCC PH 102 (Microcrystalline Cellulose), HPMC K4M, HPMC K15M are pass through the mesh no.24 and mix in the bowl for dry mixing purpose.
Step 3: Preparation of Drug and Excipient Damp Mass
Drug solution which is directly added into the Dry mixture in Rapid mixture Granulator and prepare damp mass by using required quantity of purified water. Mix well until a damp mass is formed (the mixture should hold together when pressed but should not be too wet).
Step 4: Wet Sieving
Pass the damp mass through sieve no. #24 to form uniform granules.
Step 5: Drying
Dry the wet granules properly in Tray Dryer to remove moisture content from Drug granules
Step 6: Compression
Compress the dried granules into tablets using a single tablet compression machine.
Step 7: Coating
Coat the compressed tablets by using film coating solution (HPMC and Isopropyl Alcohol) to achieve uniform layer of tablet.
Karan Agale*, Neha Said, Vishal Madankar, Formulation and Evaluation of Omeprazole Floating Tablet for The Treatment of Peptic Ulcer, Int. J. Sci. R. Tech., 2025, 2 (6), 33-40. https://doi.org/10.5281/zenodo.15568974
10.5281/zenodo.15568974
