DESIGN AND DEVELOPMENT OF FLUORO CALCIUM PHOSPHOSILICATE (FCPS) LOADED MUCOADHESIVE ORAL GEL FOR THE MANAGEMENT OF DENTIN HYPERSENSITIVITY

Dentin hypersensitivity (DH) remains one of the most prevalent and clinically challenging oral health conditions encountered in dental practice worldwide. Characterized by sharp, transient pain arising from exposed dentin in response to thermal, tactile, osmotic, evaporative, or chemical stimuli, DH significantly impairs quality of life in affected individuals. Despite a multitude of desensitizing agents currently available, definitive long-term relief remains elusive owing to inadequate retention of formulations at the site of action and incomplete dentinal tubule occlusion. The present investigation was undertaken to design, develop, and evaluate a mucoadhesive oral gel incorporating Fluoro Calcium Phosphosilicate (FCPS), a novel bioactive glass-ceramic compound with demonstrated remineralizing and tubule-occluding properties. FCPS nanoparticles were characterized and incorporated into a mucoadhesive polymeric gel matrix composed of Carbopol 940 and Hydroxypropyl Methylcellulose (HPMC) in varying concentrations across six optimized formulations (F1-F6). The gels were evaluated for pH, viscosity, spreadability, mucoadhesive strength, drug content uniformity, in-vitro release kinetics, short-term stability, and anti-hypersensitivity potential using a simulated dentinal fluid (SDF) model. Results revealed that formulation F4 exhibited optimal physicochemical characteristics: pH of 6.8 (within the salivary range), viscosity of 18,420 cP, spreadability of 6.2 g.cm/sec, mucoadhesive strength of 28.5 g, and drug content of 98.7%. In-vitro release studies demonstrated a sustained release profile over 8 hours (78.4%) following Higuchi kinetics (R2 = 0.9921), indicating diffusion-controlled release. SEM analysis confirmed significant dentinal tubule occlusion following FCPS gel application. The optimized formulation demonstrated superior performance compared to a marketed desensitizing gel in all critical parameters. The study conclusively establishes FCPS-loaded mucoadhesive oral gel as a promising, patient-compliant therapeutic platform for the long-term management of dentin hypersensitivity.