FORMULATION AND EVALUATION OF FILM COATED DASATINIB IMMEDIATE RELEASE TABLETS

Abstract

Immediate release tablets defined as solid dosage form which contain a medicinal substance or active ingredient which disintegrates rapidly within minutes after administered through oral route. Dasatinib inhibits the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines over expressing BCR-ABL. Main criterion for immediate release dosage form is poor solubility of the drug and need the immediate action of drug to treat  any unwanted defect or disease. Current research work is mainly deals with development of patent non-infringing generic version for sprycel (IR tablets of Disatinib) with direct compression method by using croscarmellose sodium, sodium starch glycolate and crosspovidone as the superdisintegrants with 2.5%, 3.5% and 4.5% concentrations. All the formulations were evaluated for their pre-compression and post-compression parameters. Among all the formulations formulation F3 (4.5 % crosscormellose sodium) was found to be optimized formulation based on its dissolution profile comparison was found to be optimized formulation based on its dissolution profile comparison with innovator product before and after stability studies.

Keywords: Immediate release tablets, crosscarmellose sodium, cross povidone.