Formulation and in vitro evaluation of fast dissolving tablet of Lurasidone: A study on the effect of Cross Carmellose and Sodium starch glycolate on release profile of drug

Abstract

The atypical antipsychotic medication lurasidone is used to treat schizophrenia and other psychotic (mental) disorder symptoms. that completely inhibits serotonin 5-HT2A and 5-HT7 receptors as well as dopamine D2 receptors. The BCS classification of lurasidone places it in class II, and it has a very low water solubility. With the goal of achieving rapid disintegration in gastric pH and quick action for acute conditions for therapeutic benefits to patients, studies were conducted on the formulation and design of fast dissolving tablets of lurasidone using super disintegrants like cross carmellose and sodium starch glycolate. Six different fast-dissolving tablet formulations of Luracedone are made using the wet granulation process. To make sure there is no interaction between the drug and the various excipients used in the formulation, FTIR experiments were conducted on the pure drug Lurasidone as well as on physical mixtures of the drug and excipients. Different pre- and post-compression characterizations of the tablet were conducted, and the results complied with pharmacopoeia requirements. For several formulations, in vitro release tests were performed using a USP II paddle type dissolve equipment; the formulation (LFDT) containing 3% sodium starch glycolate provided the best release profile. For the zero order and first order kinetic models, as well as the zero-order kinetic model incorporating drug release mechanism, in vitro release kinetic investigations were conducted. Studies on accelerated stability were conducted, and they verified the stability of dose formulations.