FORMULATION, DEVELOPMENT AND EVALUATION OF LEFLUNOMIDE TABLETS
*Pankaj kumar1, K. l. Senthilkumar2, Shivramakrishna3
1Roorkee college of Pharmacy, Roorkee, Uttrakhand, India
2Padmavathi college of Pharmacy, Dharmapuri, Tamil Nadu, India
3Sai Mirra Innopharm Industry, Chennai, India
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.
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