Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING TABLET OF FENOFIBRATE BY MELT GRANULATION PROCESS

Megha Gandhi* and Kajal A. Pradhan

ABSTRACT

The major goal of this research is to increase the dissolution and hence bioavailability of fenofibrate, a practically insoluble anti-hyperlipidemic medication, by adopting a melting granulation method to create rapid dissolving tablets. Fenofibrate granules were made in a 4:6 ratio utilising polyethylene glycol 400 and 6000 as hydrophilic meltable binder and no solvent as granulating agent, resulting in a mixture with a melting point of 37 0C that would melt when placed in the mouth. The moulding process was used to make fenofibrate tablets that dissolve quickly. The hardness, friability, thickness, and disintegration time of the FDTs were all measured. The USP method was used to determine the dissolution profile of Fenofibrate tablets, which was then compared to that of a commercial product. Fenofibrate FDTs with satisfactory flow ability and compressibility were developed.The fast dissolving Tablets showed more than 90% release within 50-60 minutes. Within 50-60 minutes, the fast-dissolving Tablets released more than 90% of the medication. Three-dimensional response surface plots and two-dimensional counter plots were used to depict design space using response surface methods. The optimised batch was submitted to a one-month stability investigation at 25°C and 60% RH. Using the bracket approach and the Q rule, the shelf life at 5 0C was calculated to be 1.0- 1.25 years.

Keywords: Fenofibrate, Melt granulation technique, Dissolution enhancement, PEG 400 and 6000.