Abstract

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MUCOADHESIVE BUCCAL FILMS OF VALSARTAN USING NATURAL MUCOADHESIVE POLYMERS

A. Prameela Rani and B. Radha Madhavi*

Abstract

Valsartan is an Angiotensin II receptor antagonist used in the treatment of hypertension. The conventional formulations available were considered to be low in efficacy, primarily on account of their failure in providing and maintaining effective therapeutic drug levels. As the drug undergoes high hepatic first pass metabolism it shows low bioavailability. Hence, this study aims to focus on development of a mucoadhesive buccal delivery system with an objective of offering a prolonged delivery coupled with enhanced therapeutic efficacy, patient compliance and the bioavailability. Mucoadhesive films of valsartan were prepared by solvent-casting method using novel and natural mucoadhesive polymers jack fruit gum and tamarind gum along with other polymers. Prepared films were evaluated for their weight, thickness, surface pH, swelling index, drug content uniformity, in vitro residence time, folding endurance in vitro release and permeation studies. The formulation V16 containing mucoadhesive polymer jackfruit gum was selected as sustained release mucoadhesive films of Valsartan as this formulation retards the release rate up to 8hrs and at the end of 8 hrs the release rate was found to be highest (i.e., 97.91%). Formulation V16 showed good swelling, mucoadhesive strength, a convenient residence time and promising extended drug release, which can be selected for the development of buccal film for effective therapeutic use. The data observed from this study highlight the feasibility of the buccal route as a viable option for delivery of this antihypertensive drug valsartan.

Keywords: Buccal film, Valsartan, jackfruit gum, tamarind gum, ex vivo studies.