DEVELOPMENT AND EVALUATION OF AN OSMOTIC DRUG DELIVERY SYSTEM FOR GLIBENCLAMIDE USING QUALITY ASSESSMENT METHODS

Recent advancements in Novel Drug Delivery Systems (NDDS) have significantly impacted the pharmaceutical industry by enhancing the effectiveness of existing drug molecules. Oral Osmotic Pumps, a key innovation, offer controlled and prolonged drug release, which overcomes the limitations of conventional drug delivery systems that often lack precision in drug release, leading to unpredictable plasma levels. Unlike traditional systems, osmotic drug delivery is independent of physiological factors like gastric pH, making it more reliable. These systems utilize osmosis to control drug release, with innovations such as Hydrodynamic Pressure Controlled Systems and Intragastric Floating Tablets further improving therapeutic outcomes. This research focuses on the development of an osmotic drug delivery system for Glibenclamide, an antidiabetic medication. Glibenclamide, a BCS Class II drug with a short elimination half-life, requires frequent dosing, which can lead to noncompliance. The proposed controlled porosity osmotic pump aims to enhance patient compliance, improve efficacy, and provide consistent bioavailability by utilizing osmotic agents and polymers like HPMC K100M to control drug release. Advanced Quality Assessment Techniques such as Design of Experiments (DoE) and Quality by Design (QbD) were employed to optimize the formulation, ensuring reliable and effective treatment for patients with Non-Insulin Dependent Diabetes Mellitus (NIDDM).

Keywords: NDDS, Controlled porosity Osmotic System, Glibenclamide, Quality assessment methods.