Formulation and Characterization of Bilayer Tablet of Anti-hyperlipidemic BCS Class II drug

Abstract

The main objective of work was to formulate co-loaded bilayer tablets of atorvastatin (ATV) and ezetimibe(EZM).ATV loaded in the immediate-release (IR) layer is an HMG CoA reductase inhibitor, while EZM, added in the immediate-release (IR)  layer, is a lipid-lowering agent. The immediate release of BCS class II drugs atorvastatin and Ezetimibe, in a bilayer approach was achieved by  wet granulation and fluid bed granulation  followed by compression. The Preformulation studies like, bulk density, tapped density, moisture content, forced degradation study and compatibility of API with all excipients were carried out. The dissolution study of optimize formula were carried out using pH 6.8 phosphate buffer + 0.2%w/v tween 80. Coating was done with opadry white (non-functional coating).

The main objective of work was to formulate co-loaded bilayer tablets of atorvastatin (ATV) and ezetimibe(EZM).ATV loaded in the immediate-release (IR) layer is an HMG CoA reductase inhibitor, while EZM, added in the immediate-release (IR)  layer, is a lipid-lowering agent. The immediate release of BCS class II drugs atorvastatin and Ezetimibe, in a bilayer approach was achieved by  wet granulation and fluid bed granulation  followed by compression. The Preformulation studies like, bulk density, tapped density, moisture content, forced degradation study and compatibility of API with all excipients were carried out. The dissolution study of optimize formula were carried out using pH 6.8 phosphate buffer + 0.2%w/v tween 80. Coating was done with opadry white (non-functional coating).