Formulation and Evaluation of Fenofibrate SR Capsules

B. Ramya Krishna¹, Gampa Vijaya Kumar*², P. Sridhar³, K. Someshwar^4
1CVM college of Pharmacy, Karimnagar, Telangana, India
²Professor & Principal, CVM college of Pharmacy, Karimnagar, Telangana, India
³Assistant professor, CVM college of Pharmacy, Karimnagar, Telangana, India
⁴Managers, Formulation R&D, KP Labs (A Division of KDPL), Kothapet, Hyderabad, Telangana, India

A B S T R A C T
Fenofibrate is a poorly water-soluble drug, which is used in lipid regulation by decreasing low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) levels, used in the treatment of hypercholesterolaemia, hypertriglyceridaemia, dyslipidaemia. In this study Fenofibrate pellets (250 mg) are prepared by Fluidized Bed Processing. Eight formulations of sustained release pellets are prepared by incorporating different absorption enhancers, solubilizers. Trial 8 was found to be best of all the trials showing drug release of 93% matching the innovator product. The results were found to be super imposable with each other. Stability study is carried out for 3 months at 25°C±2°C; 60%±5% RH: and 40°C±2°C; 75%±5% RH, according to ICH guidelines. The formulation was found to be stable. The optimized formula shall be utilized for the formulation development and other studies like bio-equivalence study, for successful launching of the product.
Keywords: Fenofibrate, Fluidized bed process, HPMC polymers.