DESIGN AND EVALUATION OF ORAL ANTIDIABETIC AGENTS AS BILAYERED TABLETS

Abstract

The present work, an industrial project, entitled Formulation Development and Evaluation of metformin hydrochloride sustained release and glimepiride immediate release bilayered Tablet, taken up in a collaboration with NISHKA Laboratories, Hyderabad, Andhra Pradesh. newline newlineThe literature review showed that these two drugs used for treating NIDDM have different mechanisms of actions and different pharmacokinetic profiles. Granulation methods used for the formulation of bilayered tablets are wet granulation and direct compression for metformin hydrochloride and whereas wet granulation for glimepiride. Out of which direct compression method was easy to process, economical and compatibile. Polymers as release retarding agents used in this work are HCO AND HPMC. Of which hydrogenated castor oil was rejected due to its instability to heat generated (deformation of hydrogenated castor oil) during compression of metformin and glimepiride blend into bilayered tablets newlineThe in-house prepared tablets were showing good drug release profile than the marketed one and exhibited similar release profile to that of innovator products glucophage (metformin hydrochloride 500 mg) and Amaryl (glimepiride 2 mg) newline newlineAn attempt was made to formulate metformin hydrochloride and glimepiride into gastroretentive floating bilayered tablet dosage form. A successful floating bilayered tablet was formulated. newline newline