Abstract

FORMULATION AND EVALUATION OF BI-LAYER FAST-MELTING BUCCO-ADHESIVE FILM FOR IMMEDIATE COOLING AND VITAMIN B12 SUSTAINED DELIVERY

Dr. J. P. Shanmadi1*, E. Karthikeyan and A. Lakshminarayanan

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Abstract

The current research focuses on the formulation and evaluation of bilayer fast-melting Bucco-adhesive film developed for immediate oral relief and vitamin B12 sustained delivery. In this formulation, the top layer was loaded with menthol for fast cooling via TRMP8 receptor activation and a mucoadhesive bottom layer of nano encapsulated vitamin B12 foe sustained release. The fast-melting layer was composed of HPMC and PEG- 400 and mucoadhesive layer with employed chitosan and sodium alginate. Physicochemical characterisation of the formulation showed buccal film with uniform thickness of (0.18±0.02mm), folding endurance of >300 folds and have 4.6±0.4N/MM2 tensile strength. Disintegration occurred within 24±3 seconds that releases 90% menthol within 5 minutes. Moreover, vitamin B12 release extended over 6 hours with 82.3+_4.2% encapsulation efficacy. SEM and FTIR conformed compatibility and structural integrity. In-vitro permeation in Franz diffusion cells highlights potential of mucosal delivery by showing flux of 5.4 μg/cm²/h. Statistical analysis states significant permeation (p

Keywords: Mucoadhesive buccal films, vitamin B12, menthol, nanoencapsulation, sustained release, fast- melting.