Design and development of Ondansetron-loaded polysaccharide-based buoyant formulation for improved gastric retention...

Extended gastric residence of drugs can enhance the therapeutic effect, increase bioavailability, improve efficacy, and reduce the number of required doses by prolonging the retention of the drug delivery system. A new floating drug delivery for Ondansetron was designed and evaluated. Pre-formulation studies included the assessment of powder flow properties and drug-excipient compatibility. In-vitro release studies and a buoyancy test were performed to characterize the performance of the system. The study evaluated the properties of Ondansetron tablets. The optimized batches had compressibility index values ranging from 7.272 % to 25 %, with percentage weight fluctuation ranging from 0 to 1.05 %. The tablets were 2.92 and 3.52 mm thick, hardness between 3.50 and 4.65 kg/cm², and loss percentages between 0.12 and 0.68 %, except batch T8, which had high friability index values of 1.02. Thermo-gravimetric analysis and Differential scanning Calorimetry showed no interaction between the drug and other polymers. Formulations showed a sustained release of the drug for periods of >12 h for several compositions, while some showed a release of >90 %. The formulations with HPMC K4M showed slower drug release due to a strong hydro layer. Citric acid content increased drug release, suggesting modulation of drug release kinetics. Kinetic modeling revealed that some of the formulations exhibited zero-order release kinetics, which means that the drug is released at a constant rate to maintain a steady level of the drug in the body. This project aims to improve the therapeutic effect of Class I Biopharmaceutical Classification System (BCS I) drug ondansetron by using a stomach-retaining, floating drug delivery system. Promising results are indicative of better bioavailability and sustained therapeutic doses. Findings may influence the development of delivery methods for similar substances facing gastrointestinal absorption challenges.