Publication

Abstract : Pharmaceutical industries are known for their batch operations using wide varieties of solvents, reactants, and catalysts. To study the efficiency of production process within a pharmaceutical industry, synthesis of an active pharmaceutical ingredient (API) namely, aliskiren hemifumarate (AH) was analyzed, which is a blood-pressure-lowering medicine. The process mass index, a metric to assess the efficiency of AH production, was calculated. It was found that the process mass index for the AH synthesis was 109 kg raw materials/kg of product, which showed the amount of waste generated during its synthesis. In addition, a life cycle assessment (LCA) study was performed on AH synthesis to understand the overall impacts throughout the life cycle of the product. The results of the LCA revealed that among the various raw materials required, the metal catalyst palladium and solvent dichloromethane were found to have the highest impact on the environment as well as on human health. Both the metal catalyst and solvent play important roles in improving the sustainability of the production. Therefore, the study was extended by comparing the base case with two scenarios of process modification, replacing the toxic palladium with other catalysts and replacing dichloromethane with ethanol, acetone, and benzene. The results of the modified case showed a reduction in the impacts on human health by 97.7%, on the ecosystem by 98.3%, and on resources by 74.1%, thus enhancing the sustainability of the overall process.