Design of an industrial process for the topiramate production

Abstract

Topiramate is a sulfamate substituted monosaccharide derivative which is useful in the treatment of epilepsy (in children and adults), obesity, bipolar disorder, neuropathic pain, migraine and smoking cessation. The production of topiramate consists in two stages, the synthesis of technical topiramate from DAF’s, and the purification of technical topiramate to achieve commercial topiramate with 98.9% of purity. The aim of the project is to plan a batch process in an industrial scale for the synthesis and purification of topiramate. The size of the batch should be enough to allow the annual production of 20,000 kg/year of Topiramate. The batch size is fixed in 1000 kg/batch by “la Agencia Española del Medicamento”. (1) One of the aims of this project is to realize the production with the minimum number of required equipments. This equipments have been dimensioned as well as the mass balance has been made. The heat exchanger system has been dimensioned in the worst operating conditions, to oversize the system and guarantee that if there are any disturbance the system will be able to heat or cool the solution. The required pipes, valves and pumps have been chosen, taking into account the control parameters in the P&iD. To carry out the production program, it has been considered that production takes place 24 hours/day, in three shifts, 7 days/week and 48 weeks/year. It has been considered that the plant works approximately 220 days/years and the rest of the days will be for repairing breakdowns in some equipment’s, or delays in the receipt of raw materials. Besides, it has been estimated the occupation time of each equipment and determined the bottleneck of the process. The production is schedule in overlapping campaigns, assuming that the plant works in multipurpose production.