Design of a batch plant for ivabradine manufacture

Abstract

Heart failure is a disease that affects over 37.7 million people worldwide. Due to its major concern, several investigations are taking place nowadays, resulting in a variety of drugs with significant impact in the treatment of different heart pathologies. This is the case of ivabradine, a compound that has represented an alternative to classic heart treatments during recent years and which generic medicine is just available. Thus, representing a huge market opportunity for new manufacturers willing to produce this active ingredient. The aim of this project is to provide a feasible manufacturing process for this compound on an industrial scale, in addition to basic equipment selection and emphasis on the production programming. A broad study of the state of the art of patents for ivabradine synthesis is performed with the purpose of selecting the most suitable patent to take to the industrial scale for the manufacture of ivabradine, as well as acknowledging alternatives for the operations and compounds selected on each stage of the production process. Moreover, production requirements and batch size are determined. The work is complemented with the selection of the main equipment required, according to the actual commercial offer, for the industrial execution of the synthesis designed. Finally, effort is dedicated to the study of the production schedule in order to optimize the available resources and increase the annual production of the active principle