Abstract

QUETIAPINE FUMARATE: A SUSTAIN RELEASE FORMULATION FOR SCHIZOPHRENIA AND BI-POLOR DISORDER

Singh Prerana* and Gnanarajan G.

ABSTRACT

The main objective of the present study was to formulate & develope of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product i.e Quetiapine fumarate (QF) 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, tablets were prepared using blends of high and low viscosity grades of hydroxypropyl methylcellulose(HPMC K4M and K100LV, respectively), which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals. After the analysis of the experimental design, optimal formulas and the design space were defined. Optimal formulas demonstrated zero-order release kinetics. It was concluded that the this approach allowed fast development of sustained release tablets with similar dissolution behavior as the innovator product.

Keywords: Quality target product profile (QTPP), Quetiapine fumarate (QF), Hydroxypropyl methylcellulose (HPMC), Critical quality attributes(CQAs), Release kinetics.