Abstract

FORMULATION AND IN-VITRO EVALUATION OF DUAL RELEASE LOSARTAN POTASSIUM PELLETS BY 32 FACTORIAL DESIGN

T. Arokkiya Angel* and S. Allimalarkodi

Abstract

Multi-particulate drug delivery systems are utmost accepted and widely used dosage form as they offer so many benefits over unit dosage form like improved bio-availability because of increased surface area, reduced inter-subject variation and reduced chances of dose dumping. Pelletization is one of the most promising technique for the multi-particulate drug delivery system. The purpose of this study to apply the QbD approach to optimize the formulation of a dual release pellets containing Losartan potassium prepared by extrusion and spheronization. A 32 full factorial design is the simple experimental design with two variables studied at three levels. In the present study, the type of polymers used HPMC (X1) and percent polymer replaced with MCC (X2) to achieve Sustained release of Losartan potassium taken as independent formulations variables. The Critical quality attributes (CQA) to be applied for formulation development is the response factors, such as the dissolution profiles at 2nd hr and 8th hr to be taken as dependent response variables. The optimized formulation to be characterized by comparison with the various physical properties and in-vitro pharmacokinetic parameters.

Keywords: Dual Release Pellets, Sustained release, Immediate release, Losartan potassium.