Formulation and Evaluation of Buccal film of Rabeprazole sodium

Abstract

Novel drug delivery systems are designed to ensure continuous delivery of drugs in predictable and reproducible kinetics over prolonged time. Buccal drug delivery system localizes the delivery of drug to tissues in the oral cavity for treatment of bacterial and fungal infection as in various periodontal diseases. This study aimed to formulate buccal film of rabeprazole drug with Hibiscus rosasinensis mucilage and Basil leaves extract. It improves therapeutic efficacy, patient compliance and the bioavailability. The present formulation targets oral ulcers that will remain in the application site for a longer period and minimizing the side effects. rabeprazole sodium, Hibiscus rosasinensis mucilage and Basil leaves extract was used for Pharmacological activity and incorporated into the buccal film prepared by solvent casting method. In the present study six formulations of rabeprazole alone and in combination with Hibiscus rosasinensis mucilage and Basil leaves extract were prepared as buccal films, by solvent casting technique. Six The F1–F6 formulations contain rabeprazole sodium, Hibiscus rosasinensis mucilage, Basil leaves HPMC, Polyvinyl alcohol, Sodium alginate, and Propylene glycol and Distilled water. Prepared film was evaluated for different parameter including pH, thickness, weight variation, folding endurance, moisture uptake and moisture content, swellability, drug content, tensile strength, in vitro drug release and stability studies. The Formulation F3was considered as ideal film with maximum release of 98.90%. F3 shows maximum disintegration time of 25 min, tensile strength of 6.98. The drug content of the formulation F3 was found to be 98.47%. The maximum moisture content showed in F4 and minimum in F2. Stability of this film was also monitored for 2 months without having any signs of deterioration, difference in pH, drug content and drug release. This study demonstrates the prospective use of buccal films as a viable and alternative approach for effective delivery of rabeprazole in treatment of Oral ulcers.