Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF LEFLUNOMIDE TABLETS

*Pankaj kumar¹, K. l. Senthilkumar², Shivramakrishna³

Abstract

DMARDs (Disease Modifying Anti Rheumatic drug) reduces the rate of damage to the bone and cartilage. They prevent bone and joint damage from occurring secondary to the uncontrolled inflammation. Leflunomide is recently introduced immonumodulator inhibits proliferation of activated lymphocytes in patients with Rheumatoid arthritis. Arthritis symptoms are suppressed and radiological progression of disease is retarded. The study was under taken with an aim of Formulation, Development and Evaluation of leflunomide Tablets using excipients. Preformulation study was done on pure drugs and granules and results directed for further course of formulation. Based on preformulation studies different batches of leflunomide were formulated using selected excipients. Granules were evaluated for Loss on drying, Angle of repose, Bulk density, Tapped density, Compressibility Index and Hausner’s Ratio. Tablets were tested for weight variation, thickness, hardness, disintegration time, In-vitro drug release studies as per specifications.The formulation that has been found to posses ideal characteristics required for leflunomide 10mg, 20mg Tablets, so it was concluded as the final formula for leflunomide 10mg and 20 mg tablets are 150mg, 200 mg respectively made by co-precipitation of drug with PVP.The drug release profile of leflunomide compared with the market sample. From the studies it was concluded that formulation of leflunomide Tablets containing lactose monohydrate, starch, povidone, crospovidone, mg stearate , aerosil taken as ideal or optimized formulation of tablets.

Keywords: Immonumodulator, Bulk density, Tapped density, Compressibility Index.