FORMULATION AND EVALUATION OF BUCCOADHESIVE GEL FOR THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS

Abstract

Oral submucosal fibrosis (OSF) is a disease affecting the oral cavity and characterized by chronic, complex, irreversible, potentially malignant disorder (PMD) and crippling condition of oral mucosa, various delivery systems for administration & delivery of drugs to the oral cavity for treatment of OSF have been developed. The developed delivery systems mostly contain a single drug, while treatment of OSF is based on multiple drug approach. In the present work it is proposed to formulate and evaluate buccoadhesive gel of two drugs that is metronidazole and lycopene as topical antioxidant. In the present study five batches of metronidazole and lycopene gels were prepared using natural biodegradable polymer Carbopol 934p and sodium carboxy methyl cellulose. The influence of polymer type and polymers blend in varying ratio on the viscosity, buccoadhesive strength, spreadability, extrudability and drug release were evaluated. SCMC based gel showed fastest release in comparison with Carbopol based gel. Using polymer blend of SCMC with Carbopol resulted in a modification of both release and physical properties. The release of metronidazole was decreased with increasing amount of Carbopol and decreasing amount of SCMC. And increasing the viscosity of the gel formulations resulted in a retardation effect on the release of the drug. The study also showed that formulas containing Carbopol exhibited maximum viscosity with lower release rates and best buccoadhesion.

Key words: Oral submucosal fibrosis, metronidazole, lycopene, buccoadhesion