Abstract

FORMULATION AND CHARACTERIZATION OF CLOZAPINE ORO-DISPERSIBLE TABLETS

Dr. M. Sunitha Reddy*, Jakka Sravanthy and S. Muhammad Fazal-Ul-Huq

ABSTRACT

Clozapine (CLOZ) is an atypical antipsychotic agent used in the management of schizophrenia. It exhibits extensive first pass metabolism with poor oral bioavailability (27%–50%) limiting its therapeutic efficiency. The aim of this study is to formulate Oro-Dispersible Tablets with sufficient mechanical integrity and to achieve faster disintegration in the oral cavity without water. To achieve this goal, mannitol used as diluent in the formulation of tablets by direct compression method. Attempts were made to enhance dissolution rate along with faster disintegration using different excipients like Lactose Anhydrous NF DT, Lactose Monohydrate DCC II SD and Crospovidone. Physical parameters like bulk density, tapped density, carrs index, hausners ratio, angle of repose, weight variation, friability, hardness, content of active ingredient, disintegration time were also studied. Solid state characterisation of samples was carried out by X-ray diffraction (XRD), differential scanning calorimetric (DSC), Fourier transform infrared spectrophotometry (FTIR) studies. In-vitro dissolution studies were carried out with 900ml of 0.1N HCl as dissolution Media. Among the all formulations Crospovidone with 8% shown the lesser disintegration time i.e. 20 mins and higher dissolution rate i.e. 99.99%.

Keywords: Oro-Dispersible Tablets, Clozapine, Lactose Anhydrous NF DT, Lactose Monohydrate DCC II SD, Crospovidone, direct compression method, XRD, DSC, FTIR studies. In-vitro dissolution.