Abstract

ORLISTAT LOADED EFFERVESCENT GRANULES FOR THE MANAGEMENT OF OBESITY

Shweta Kumari* and K. P. Meena

ABSTRACT

The main aim of study was to prepared orlistat loaded effervescent granules by wet granulation technique for the management of obesity Orlistat was selected as model drug. The characterization of orlistat pure drug was done by melting point, FTIR and DSC. The solubility analysis and partition coefficient was recorded to ensure the nature of drug. Analytical method of validation for orlistat was done through by making a orlistat conformer complex by the help of 2, 4- dinitro phenyl hydrazine. By taking this orlistat conformer complex lambda maxima was recorded by U.V spectrophotometrically. Selection of excipients and other chemical was done on the basis of literature survey. To formulate the effervescent granules design expert software 10.0.1, CCD approach was used in which independent variables was amount of sodium bicarbonate, and amount of sodium starch glycolate. Dependent variable was effervescent time, carbon dioxide release, and drug release. By putting data in design expert software it was suggested to develop nine formulations which were coded as EFG1 to EFG9 by varying amount of sodium starchglycolate and sodium bicarbonate. Characterization of effervescent granules were done for angle of repose, bulk density, tapped density, compressibility index, determination of pH, carbon dioxide release, effervescent time, drug content and drug release.. The mechanism of drug release was studied by model fitting curve such as, zero order, first order, Korsmeyer Peppas model, Higuchi model, and Hixson Crowell model and found all formulation follows non-fickian flow as values of n was found to be greater than 0.5 but less than 1. Optimization was done on the basis of data obtained and design expert software. And suggested Formulation EFG5 was selected amongst all formulation. Formulations EFG5 was shown less effervescent cessation time. But on increasing amount sodium starchglycolate and Sodium bicarbonate, carbon dioxide release was also increased and drug release was found to be maximum. Stability studies was performed and shown significant changes will occur.

Keywords: Effervescent granules, Obesity, Wet granulation, Release mechanism, Orlistat.