Abstract

FORMULATION AND EVALUATION OF FAST ORAL DISSOLVING FILMS OF CARVEDILOL

G. Swathi*, K. Saikumar, K. Brahma, B. Moulika Lakshmi, C. Raga Deepthi, S. Sravani, P. Indira and Dr. P. Shailaja

ABSTRACT

Carvedilol is an anti-hypertensive agent used to treat congestive heart failure, left ventricular dysfunction following myocardial infarction, hypertension. The drug belongs to BCS class II drug, which is practically insoluble in water, has poor dissolution rate. These properties are associated with slow drug absorption leading to inadequate and unpredictable bioavailability. The Fast oral dissolving films (FDFs) of Carvedilol were prepared with an objective of immediate release, improved bioavailability of drug, faster onset of action and patient compliance. In this study, Carvedilol is formulated into FDFs using solvent casting method. Hydroxyl propyl methyl cellulose-E5 (HPMC-E5) and Poly vinyl alcohol (PVA) are used as film forming polymers, Poly ethylene glycol-400 (PEG-400) is used as plasticizer, ethanol water are used as solvents, citric acid is used as saliva stimulating agent, sucrose and menthol are used as sweetening and flavouring agents, tween 80 is used as surfactant. The FDFs were evaluated for transparency, thickness test, folding endurance, weight variation, swelling property, surface pH, drug content uniformity and disintegration time, in-vitro dissolution test, ex-vivo and stability studies. Among all the prepared FDFs, F2 is the better dosage form showing all the desired objectives.

Keywords: Carvedilol, Fast oral dissolving films, immediate release, solvent casting method, HPMC E5, PVA, ex-vivo studies.