Chitosan/ Alginate/ Gelucire in-situ Gelling System for Oral Sustained Delivery of Paracetamol for Dysphagic Patients

The study aims to formulate an oral in-situ gel for sustained paracetamol delivery, targeting pediatric and geriatric patients. A blend of sodium alginate, chitosan, and Gelucires was used to create the gel. Characterization techniques, such as rheology and in vivo bioavailability tests on rat models, were employed. The in-situ gel transitioned into a gel-matrix system in 0.1N HCl, effectively controlling the release of paracetamol at different pH levels (1.2, 5.4, and 6.8). Gels made solely of sodium alginate or sodium alginate-chitosan exhibited rapid drug release at pH 6.8. The formulation containing paracetamol in a Gelucire (G33/01):3-3% sodium alginate - chitosan ratio of 1:1:4 w/w showed an extended drug release time of over 8 hours. Bioavailability in rats revealed a higher time to maximum concentration (Tmax) and lower peak concentration (Cmax) but comparable mean residence time (MRT) and area under the curve (AUC0-∞) to commercial formulations. The gel's synergistic blend of chitosan, sodium alginate, and Gelucire G33/01 ensures a sustained release of paracetamol, making it a promising drug delivery system for vulnerable populations like children and the elderly.