Abstract

FORMULATION, STATISTICAL OPTIMIZATION AND EVALUATION OF INCLUSION COMPLEXED FAST ORAL DISSOLVING FILMS OF CARVEDILOL

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

ABSTRACT

Carvedilol is a β-blocker, belongs to BCS class II, with low oral bioavailability (25%), primarily used for the treatment of hypertension, and heart failure, after a heart attack to improve the chance of survival, prevents strokes kidney problems. The purpose of this research is to formulate carvedilol as oral dissolving films to provide an immediate release of drug and fast onset of action, thereby improving the bioavailability. The films are prepared by solvent casting method using polymers such as HPMC, PVA and PVP in different composition in addition with poly ethylene glycol-400 as plasticizer. The formulated films are assessed for their physicochemical parameters such as transparency, thickness, weight variation, folding endurance, surface pH, disintegration time, swelling studies and drug content uniformity, in vitro dissolution study. The optimized films were characterized for interaction studies by FT-IR. To increase the percentage of drug release at minimum duration, the drug with β cyclodextrin is prepared as inclusion complex by kneading method using 32 factorial design, the optimized inclusion complex mixture was incorporated into the films, and further optimized by the evaluation studies. The optimized non-inclusion complexed and inclusion complexed FDF formulations were evaluated for Ex-vivo drug release study using porcine oral mucosa and stability studies.

Keywords: Carvedilol, Fast Dissolving Films, Solvent Casting, Kneading Method, Inclusion Complexation, Non-Inclusion Complexed FDFs.