“FORMULATION AND EVALUATION OF BUCCAL FILMS OF SAXAGLIPTIN”

Objective: Saxagliptin is an orally anti-diabetic drug. It has an oral bioavailability of 50% due to first pass hepatic metabolism. To achieve sustained action of drug, reduce dosing frequency, bypass the hepatic first pass effect and improve bioavailability, buccal films formulation was planned. Methods: Compatibility of the drug with the excipients was studied with the help of FTIR. 23 factorial design was planned using concentration of Sodium alginate, concentration of Chitosan and PEG 400. Solvent casting method was used for the fabrication of films. Weight, thickness, surface pH, mucoadhesive strength, in vitro residence time, % swelling and % drug release were evaluated for the prepared film formulations. Results: All the films were found have surface pH close to neutral pH and were found to have content uniformity. Mucoadhesive strength was found to increase with increase in concentration of Chitosan. Drug release is more controlled by the high swelling film formers than sodium alginate. Among the film formers, though swelling is more, % drug release is also more from sodium alginate and Chitosan films because of its ionic nature and more solubility. Conclusion: Because of high mucoadhesive strength and more % drug release, combination of Sodium alginate with Chitosan film formulations was selected.  Key Words: Saxagliptin, Buccal films