Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLET OF CLOZAPINE

Pradip Solanki*, Pratik Upadhyay, Dr. Shreeraj Shah and Jaimin Patel

ABSTRACT

The aim of the present study was to develop the mouth dissolving tablets of clozapine to treat the symptoms of schizophrenia. Solubility of drug was increased by cyclodextrin inclusion complexes, β-CD and HP β-CD, from which HP β-CD shows high solubility. Trial studies for screening of diluents and superdisintegrants was carried out. Combination of CCS: CP was shown decreased disintegration time. 32 factorial design was applied for the formulations, considering X1 as molar ratio of CLZ: HP β-CD and X2 as amount of CCS: CP. Physical parameters like weight variation, friability, hardness, content of active ingredient, disintegration time and wetting time were also studied. In-vitro dissolution studies were carried out with 900ml of simulatory salivary fluid. Most of the tablets complied with the pharmacopoeial standards. Among the all 9 batches F5 batch shown the lesser disintegration time i.e. 22 sec and higher dissolution i.e. 95.83%.

Keywords: Mouth dissolving tablet, clozapine, superdisintegrants, in-vitro dissolution.