Development and Characterization of Nicotinic acid Extended Release Tablets with Hydrophobic Polymer

ABSTRACT

Nicotinic acid is widely used since long period of time as antihyperlipidemic agent in extended release tablet dosage form with high dose. It is rapidly absorbed in GI tract and undergo extensive metabolism. This leads to high variable plasma drug concentration, which may correlate with the side effects of Nicotinic acid. Available marketed formulation shows good correlation of in-vitro dissolution profile; however in-vivo performance of the formulation shows highly variable plasma concentrations. Available marketed formulation is designed with hydrophilic polymer (HPMC). This erratic in-vivo behaviour of the available marketed formulation may be due to the variability in physiological pH or impact of mobility and composition and volume of GI liquids. Here we worked on the composition as a factor and new formulation is designed with insoluble polymer. This current research is aimed to design a robust matrix tablet with insoluble polymer.

Keywords: Inter-subject Variability, Hydrophilic Polymer, Hydrophobic Polymer, Antihyperlipidemic agent, Matrix Tablet