Preparation and evaluation of mucoadhesive hydrophilic hydroxy propyl methyl cellulose based extended release matrix tablets of Niacin (Nicotinic acid)

Abstract

The aim of this study is to develop a once-daily extended release matrix tablet of Niacin using Hydroxy Propyl Methyl Cellulose i.e. Methocel K4M CR as release controlling factor and to evaluate drug release parameters as per various release kinetic models and also to find the best fitted extended release matrix formulation of Niacin. In order to achieve required extended release profile, tablets were prepared by wet granulation technique using different formulations (F-1, F-2, F-3, F-4, F-5 and F-6) with different amount of Methocel K4M CR. The formulated tablets were also characterized by physical and chemical parameters and results were found in acceptable limits. Different release kinetic models were applied in order to evaluate release of Niacin from the prepared matrix tablets. Criteria for selecting the most appropriate model were based on linearity (coefficient of correlation) and diffusion exponent of the respective kinetic model. Among all the formulations, F-5 was found as the best fitted matrix tablet for extended release of Niacin. Drug release mechanism was found as a complex mixture of diffusion, swelling and erosion.