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FORMULATION AND EVALUATION OF BUCCAL PATCH CONTAINING ACECLOFENAC

U. D. Shivhare, P. B. Suruse, S. S. Varvandkar

The main objective of the present study was to improve bioavailability of Aceclofenac and decrease the frequency of dosage form administration by sustained release formulation of the drug from the mucoadhesive drug delivery system. Aceclofenac belongs to the drug class known as NSAIDs. It is normally indicated for the treatment of dental pain, rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It is selective cox-2 inhibitor. It has an extensive and highly variable hepatic first pass metabolism following oral administration having half life of 4 h. The usual dose of Aceclofenac is 100 mg twice daily with systemic bioavailability of 40- 50% due to extensive “first-pass” metabolism and has a narrow absorption window. These characteristics make Aceclofenac a suitable drug candidate for mucoadhesive drug delivery system. Aceclofenac containing mucoadhesive buccal patches were prepared by solvent evaporation method. The buccal patches were formulated using polymers HPMC E-15 and Eudragit RL 100 alone and in combination. The buccal patches were evaluated for weight variation, thickness, folding endurance, content uniformity, swelling index, in-vitro diffusion study, in-vitro residence time and in-vitro Mucoadhesive strength. Among five formulations using factorial approach F2 showed maximum release 92.35% upto 8 h.