Formulation and In Vitro Evaluation of Fast Dissolving Sublingual Films of Agomelatine

Author(s): Lavanya A*, Chandrashekar T and Syed Shabhana

Abstract: Oral trans mucosal drug delivery is considered to be an important alternative to the per oral route for the systemic administration of drugs, as it considered the most convenient, easy, safest route of administration. Oral mucosa has rich vasculization, offers better permeability to many drugs and it act as an excellent site for the absorption of drugs. Fast dissolving oral film (FDOF) is used as a novel approach, as it dissolves rapidly in mouth and directly reaches to the systemic circulation. Oral film technology fulfills all the requirements of potential solid dosage form. The aim of this study is to formulate and evaluate the (FDOF) of an antidepressant drug (Agomelatine) and improved bioavailability of drugs as compared to conventional solid oral dosage forms. Oral films were prepared by using HPMC (Hydroxy Propyl Methyl Cellulose-E3 and E-5), Ethanol, Dichloromethane, Tween 80, combination of two polymers and other excipients. Films were prepared by the solvent casting method. Films were evaluated for mechanical properties, Morphology study, swelling properties, disintegration time, and In-vitro drug release. F10 formulation shows maximum In- vitro drug release 96.92±1.42, following first order kinetics (r2 =0.9915). The release exponent ‘n’ was found to be for F10 is 0.4487, which appears to indicate a Fickian diffusion and may indicate that the drug release was controlled by first order release.

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