FORMULATION AND EVALUATION OF PROLONGED RELEASE GEMFIBROZIL TABLETS

M. Durgarao*, G. Lakshmi Kavya, A.V. Bhanu Mallika, G. Srivinay, P. Ravi and V. Lahari

The development of prolonged-release formulations of pharmaceuticals is essential for enhancing therapeutic efficacy and patient compliance. This study focuses on the formulation and evaluation of prolonged-release Gemfibrozil tablets, a lipid-regulating agent used in the management of hyperlipidemia. The primary objective was to design a tablet that ensures sustained release of Gemfibrozil, thereby maintaining a consistent plasma concentration over an extended period. The formulation process involved the selection of appropriate polymers and excipients to achieve the desired release profile. Various formulations were prepared using hydrophilic and hydrophobic polymers, such as hydroxypropyl methylcellulose (HPMC) and ethylcellulose, through direct compression and wet granulation techniques. The tablets were then evaluated for their physical characteristics, including hardness, friability, and uniformity of weight. In vitro dissolution studies were conducted using USP type II apparatus to determine the release kinetics of Gemfibrozil from the formulations. The optimized formulation demonstrated a sustained release of Gemfibrozil over 12 hours, following a non-Fickian diffusion mechanism. The release kinetics were best described by the Korsmeyer-Peppas model, indicating a combination of diffusion and erosion mechanisms. Stability studies conducted at accelerated conditions showed that the prolonged-release tablets maintained their physical integrity and drug release profile over a period of six months.