Formulation Development and Evaluation of Fast Dissolving Oral Films of Nebivolol

Oral films dissolve rapidly along with drug in mouth and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation avoiding first pass metabolism. Hypertension is a major cause of concern not just in the elderly but also in the youngsters. An effort was made to formulate a fast dissolving film containing Nebivolol which is used in the treatment of hypertension with an objective to rapid dissolution of drug and absorption which may produce the rapid onset of action and provides the convenient means of administration to those patient suffering from difficulty in swallowing such as paediatrics, geriatric and uncooperative mentally ill patients and also improve the bioavailability of the drug. The fast dissolving oral film were prepared using different polymers like Sodium starch glycolate, Hydroxy propyl methyl cellulose, Croscarmellose sodium and Tween 80 by solvent casting method. The fast dissolving oral film evaluated for folding endurance, swelling index, surface pH, in vitro disintegration time, drug content, drug polymer compatibility (IR Study), and in vitro drug release. The physical appearance and folding endurance properties were found to be good and electron microscopy shows that films are clear, colourless with smooth surface without any scratches. The drug content showed uniform mixing of drug in all prepared fast dissolving films. The in vitro drug release in optimized formulation F9 was found to be 69.56 % in 5 min. Drug release obeys the first order kinetics. The prepared films were stable. Hence it can be inferred that the fast dissolving oral film of nebivolol may produce the rapid action thereby improving bioavailability and enhance the absorption by avoiding the first pass effect.