Design and Evaluation of The Floating Oral In Situ Gelling System of Levofloxacin Hemihydrate to Dysphagia Patients

Pediatric, geriatric, and dysphagic patients often experience difficulty swallowing solid dosage forms and discomfort with injectable administration. Levofloxacin, a fluoroquinolone antibiotic, is primarily available in tablet and injection forms, as in Indonesia. This study aimed to develop an aqueous dispersion formulation for a floating oral in situ gelling system of levofloxacin hemihydrate with sustained-release delivery as a practical and patient-friendly dosage form. Hydroxypropyl methylcellulose (HPMC) and sodium alginate were combined as polymers to form an in situ gel in an acidic environment. Formula optimization was conducted using the simplex lattice mixture design method. The formulations were evaluated for physical appearance, pH, in vitro floating behavior, in vitro gelation, viscosity, and in vitro drug release. Drug release kinetics were analyzed using both mathematical and compartmental modelling approaches. The results showed that variations in polymer concentration significantly affected the viscosity of the formulations. The developed formula exhibited rapid gelation and floating behavior that persisted for more than 24 hours. The optimum formula contained 0.378 sodium alginate and 0.122 HPMC, with a cumulative drug release of 86 within 6 hours, following the Korsmeyer-Peppas model for release mechanism. Based on compartmental modeling, the drug release mechanism fitted a two-compartment model. The developed formulation demonstrated enhanced gastric retention of levofloxacin hemihydrate, offering improved therapeutic efficacy and potential for greater patient compliance. © © 2025 by Indonesian Journal of Pharmacy (IJP)