Abstract

FORMULATION AND CHARACTERIZATION OF GASTRORETENTIVE FLOATING MULTIPLE UNIT SYSTEM OF AGOMELATINE MICROBALLOONS

Rajat J. Gadhave*, K. N. Tarkase and M. K. Tarkase

ABSTRACT

Floating drug delivery systems (FDDS) have a lower bulk density than gastric fluids (˃1g/cm2) and thus remain buoyant in stomach for a prolonged period of time, without affecting the gastric emptying rate. The current study was to formulate and evaluate Microballons for agomelatine BCS class 2 that is low solubility and high permeability. The Microballoons of agomelatine was prepared by solvent evaporation technique by using different polymer ratio. The polymers were HPMC and EC at different ratio. The effect of various formulation and process variables on the internal and external particle morphology, micromeritic properties, in vitro floating behaviour, physical state of the incorporated drug, drug loading and in vitro drug release was studied. The release rate was determined in simulated gastro-intestinal fluids at 37oc. The designed system, combining excellent buoyant ability and suitable drug release pattern, could possibly be advantageous in terms of bioavailability of agomelatine.

Keywords: Agomelatine, Floating Drug Delivery Systems, hydroxy propyl methylcellulose (HPMC), ethyl cellulose (EC).