Cradle-to-gate life cycle assessment of a liquid pharmaceutical product through analysis of chemical production pathways

There is currently an urgent need to further address environmental issues of pharmaceutical production as their production volume has steadily been increasing in the last decade and is expected to reach greater annual production volume in the future. Freshwater ecotoxicity due to production of Active Pharmaceutical Ingredients (APIs) due to wastewater generation and high cumulative primary energy demand due to complex upstream supply chains involved for the production of APIs and solvents are two main environmental issues that requires further appraisal in the literature. This study analyzes pharmaceutical production as a potential source of ecotoxicity and primary energy depletion due to API production and wastewater generation through a case study of a liquid pharmaceutical product. Upstream supply chain of APIs and Freshwater Ecotoxicity Potential (FEP) were analyzed. Raw material requirements for 17 upstream chemicals were quantified through the examination of production pathways. It was determined that the two APIs contained in the liquid product have high freshwater ecotoxicity potential compared to high production volume chemicals. Impact tree analysis for FEP showed that high FEP of APIs was linked to both organic and inorganic chemicals including benzoic acid, aniline, benzaldehyde and sodium. Similar to the case for FEP, Cumulative Energy Demand (CED) for the APIs was determined to be have much greater energy demand (249 and 218 MJ/kg) than high production volume chemicals. Analysis of FEP due to wastewater generation showed that the highest FEP contributor was API chlorhexidine gluconate. Research for alternative chemical components in the upstream supply chain showed that substitution alternatives are available and may be adopted by chemical producers and guidance tools that may enable this assessment is urgently needed.