Development And Evaluation Of An Oral Liquid Dosage Form For Lumateperone, An Anti-Psychotic Drug

Authors

Shailendra U. Goud, Dr.Santosh Tarke, Dr.Gitanjali Chavan, Mr Vishal Sakhare, Ms Ashwini Gholkar, Mr. Narsuba D. Dhavle
Department of Pharmaceutics, SBSPMs College of Pharmacy, Ambajogai, Beed, Maharashtra, India. 431517

Abstract

The novel antipsychotic drug lumateperone has demonstrated encouraging efficacy in treating a range of mental illnesses. However, some patient populations, such as those with dysphagia or paediatric patients, may experience difficulties with its current formulations, which are primarily in solid dose forms. The purpose of this study was to develop and assess an oral liquid dosage form of lumateperone in order to alleviate this limitation. In order to guarantee stability and improved bioavailability, solubility improvement techniques and compatibility tests were employed during the formulation process. To analyse formulation features, physicochemical characterisation was carried out, which involved assessments of viscosity, pH, and drug content uniformity. Studies on in vitro dissolution shed light on the kinetics of drug release and the effectiveness of the formulation.To determine long-term viability, stability evaluations under various storage settings were also conducted. The outcomes showed that lumateperone could be successfully developed into an oral liquid formulation that is stable, bioavailable, and has the desired physicochemical characteristics. Throughout the specified storage duration, the formulation showed stable and uniform drug release profiles. This study offers a practical and efficient lumateperone dosage option, marking a significant advancement in pharmaceutical technology. It may enhance treatment adherence and therapeutic outcomes, especially in patient populations for which solid dosage forms are unfeasible or difficult to administer.