Preliminary design of a batch process for the oxolamine citrate

Abstract

Oxolamine Citrate is an active ingredient of many antitussive pharmaceutical drugs. Last years, its demand has increased significantly, what has caused the necessity to increase its production. For that, it was studied experimentally the way to optimize the process that was conducting a company to produce the drug back then, determining the critical points and suggesting improvements. Through the laboratory research and implementing many modifications, it was achieved the way to increase its yield from 24% to 64%, thanks to the identification of impurities in the Oxolamine Citrate synthesis. For this reason, in this project is going to be studied how to transfer this optimized process to industrial scale. It is going to work in discontinuous mode. The process can be divided in two phases: Oxolamine Citrate synthesis and its purification. It is going to be studied the most feasible method to the synthesis phase, even if it is going to take into account the purification phase to know the batch time and the time that will take to obtain the requested production. The production that has to be satisfied is 100 tones per year. In order to achieve this quantity, it has been searched the way to get a balance between the production time and the minimum number of equipment required. Consequently, the equipment will be flexible, so when it is finished the annual production of Oxolamine Citrate, they will be able to be adapted to future processes. The equipment used is: for the synthesis phase, 4 vessels, all of them provided of a halfpipe jacket, an agitator and a condenser to assure the reflux of the liquid that could evaporate. Anyway, the capacities of these vessels are not the same, and in them are carried out different operations as can be reactions, extractions or crystallizations. In the case of the purification phase, it would be provided of a centrifuge, a rotary dryer and two micronization mills. It has been scheduled the production process, and has been dimensioned the equipment involved in the synthesis phase, apart from the control and automation system with its P&ID.Lastly, it has been achieved to produce the annual requirement of 100 tones, through the production of 46 batches of 2180 kg in a period of 8 weeks