Design and evaluation of enteric coated microporous osmotic pump tablet (ECMOPT) of quetiapine fumarate for the treatment of psychosis

Abstract

The present work investigates the feasibility of the design of an enteric coated microporous osmotic pump tablet (ECMOPT) to prolong the drug release of an antipsychotic drug, quetiapine fumarate (QTF). The ECMOPT consisted of an osmotic core coated with a microporous membrane (MPM) made up of cellulose acetate and PEG 4000 as in situ micropore former. The effect of formulation variables such as concentration of sodium chloride, types of pore former (PEG 400, PEG 4000 and PEG 6000), coat thickness (100 and 200 μm) of MPM were evaluated for drug release characteristics. The FTIR, DSC and XRD analyses were carried out to characterize physico-chemical changes of powder blend and final formulation. SEM images have confirmed in situ micropores formation in MPM. A zero order release was obtained for QTF. The formulations were found to be stable up to 3 months when tested for stability at 40°C/75% RH.