Development of a process for Citicoline

Abstract

Citicoline, is an active principle that treats one of the most common neuropathies, dementia, which in its most severe condition, can develop Alzheimer's. One of the companies that produce this drug, it is Ceuber, being the product that generates more benefit. However, with the appearance of the Asian generic drug, Ceuber decided to study a process change (US Patent 3,684,652), with the aim of protecting its market share. This study consists of two parts: first, a selection of 18 patents, and it will be selected one, the patent that cumplies better the corporative, such as: the elimination of the chromatographic column. Subsequently, basic engineering will be developed by scaling two processes in Aspen Batch process developer, the current process and the one that best meets the conditions. The last one will be simulated in two different ways, within the conditions described by the recipe, one with low productivity and the other with high, with the possibility of optimizing equipment in the favourable condition... The results of this project show that these 18 patents, four require a more exhaustive analysis. In this analysis, it is confirmed with notoriety that patent WO2013 / 12893 obtains the best productivity. Finally, the simulation corroborates the high productivity of this process, achieving the maximum by placing two overlapping reactors, in order to reduce campaign time. Basic engineering is not able to determine that the process meets the quality requirements. However, the information offered by the patent about quality and the high productivity obtained in ASPEN, it promotes to evaluate the process experimentally.