Abstract

DEVELOPMENT AND EVALUATION OF SUSTAINED RELEASE METFORMIN HCL CONSISTS OF IMMEDIATE RELEASE OF PIOGLITAZONE AND GLIMEPRIDE TRILAYER TABLETS

T. P. Parthiban, R. Kumaravelrajan* and V. Suba

Abstract

The new drug delivery system with better efficacy and safety with reduced dosing frequency and improved patient compliance is the current area of research byformulation development scientists. Tablet being most preferred dosage form for its ease of manufacturing and patient convenience is always a first choice of dosage form.The purpose of this study to apply the QbD approach to optimize the formulation of a Trilayer tablet containing Metformin hydrochloride, Pioglitazone and Glimepiride prepared by wet granulation. 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 Metformin layer taken as independent formulations variables. The Critical quality attributes (CQA) to be applied for formulation development is the response factors, such as the swelling rate and dissolution profiles. Therefore, the amount of drug released (T90), and Swelling rate to be taken as the dependent response variables. The optimized formulation to be characterized by comparison with the various physical properties and in vivo pharmacokinetic parameters.

Keywords: Trible layer, Matrix tablet, SR tablets, Metformin, Pioglitazone, Glimepride.