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Cambrex’s novel synthesis of Dronederone intermediate was recognized for its excellence in API development.
Cambrex’s novel synthesis of Dronederone intermediate emerged as the winning entry in the API development category of the CPhI Pharma Awards 2016. Cambrex was approached by a client to develop an efficient industrial process that would deliver a highly pure intermediate, which in turn, would be used in API production. One of the challenges was that the dose of the API involved was significantly higher than other established products, which meant that cost of goods could present an issue. The goal, therefore, was to use readily available raw materials with minimal environmental impact and it must be a scalable process that could be carried out on standard equipment so that significant investment could be avoided.
The synthesis of the Dronederone intermediate involves a linear, five-step process with large quantities of chlorinated solvent. It would be unsuitable for scale up if demand reached the projected peak.
Cambrex developed a novel, patentable, four-step, convergent process that uses standard plant equipment and removed all need for chlorinated solvents, giving robust, reproducible results. Waste was minimized with the recycling and reuse of solvents. A considerable reduction of the cost of goods was achieved. More importantly, the route could be efficiently scaled up to one metric ton (MT) batches. The process developed by Cambrex was innovative in that it delivers high quality product in high yields, without the need for final purification.