Accelerated stability studies of niacin and green tea extract sustained release bilayer tablets with different polymers

Abstract

Niacin and Green tea extract are used for maintaining the lipid profile in Hyperlipidemia. Currently Statins are extensively used in the treatment of Hyperlipidemia which is known to cause rhabdomyolysis. The combination of Niacin and Green tea extract as a sustained release bilayer tablets will help to reduce or avoid the statin therapy. There are many polymers available to control the release of the drugs which includes Hypromellose (K4M), Guar Gum and Sodium Carboxymethyl Cellulose. In our present study we designed to evaluate the formulations containing different polymers by accelerated stability studies and examined for the parameters of hardness, dissolution and assay for drug concentration in formulation after one, three and six months duration at controlled tropical conditions of temperature and relative humidity. From the accelerated stability study results it was observed that the formulation containing Hypromellose (K4M) as a polymer founds to be more stable.