FORMULATION AND IN-VITRO EVALUATION OF OLANZAPINE TABLET FOR SCHIZOPHRENIA AND BIPOLAR DISORDER

Olanzapine is a thienobenzodiazepine class of drugs, which has been approved by the Food and Drug Administration (FDA), for the treatment of schizophrenia, depressive episodes associated with bipolar disorder, acute manic episodes, and maintenance treatment in bipolar disorder. Recently many formulations developed such as parenteral formulations to improve compliance in the treatment of schizophrenia and to treat agitation in patients with schizophrenia and bipolar mania. Olanzapine palmate long acting injection (depot) is a novel formulation of the atypical antipsychotic Olanzapine. The aim of the study is to prepare tablet with similar elegancy, therapeutically effective, bioequivalent formulations to that of zyprexa. Here Olanzapine tablets were prepared by wet granulation method using following ingredients: Lactose monohydrate, Mannitol, L-HPC, Microcrystalline cellulose, Crospovidone, HPC EX, HPC LF, Magnesium Stearate, HPMC, Poloxamer, pectin. The tablets were evaluated for weight variation, thickness, hardness, friability, disintegration, dissolution and stability study for the best formulation F10 which is having similar release profile as that of zyprexa. Content uniformity of F10 formulation is 99-99.6%. Total impurities for the F10 is found to be 0.257% which is less than innovator’s total impurities 0.352% and the assay value of F 10 is 99.01% as in case of innovator it is 98.06. The best formulation is F10 which is having similar release profile as that of zyprexa.