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Designing Greener Active Pharmaceutical Ingredients

 
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Designing Greener Active Pharmaceutical Ingredients

Insights from the pharmaceutical industry into drug discovery and development

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Citation

Puhlmann, N., Vidaurre, R. and Kümmerer, K. (2024) ‘Designing Greener Active Pharmaceutical Ingredients: Insights from pharmaceutical industry into drug discovery and development’, European Journal of Pharmaceutical Sciences, 192, p. 106614. doi:10.1016/j.ejps.2023.106614.

Active Pharmaceutical Ingredients (APIs), their metabolites, and transformation products often act as pollutants in the environment, impacting both ecosystems and human health. To tackle this issue, an efficient, long-term prevention strategy involves designing APIs with reduced environmental impact – i.e. 'greener' APIs. This involves incorporating environmental parameters into the pharmaceutical Research and Development (R&D) process. This article explores the feasibility of designing greener APIs, drawing insights from drug design experts in major research-based pharmaceutical companies. The feasibility assessment identifies needs and incentives for process modification, based on interviews with 30 R&D and environmental experts from seven globally active pharmaceutical companies.

Opportunities and Challenges in API Design

Key findings indicate that experts see numerous opportunities to integrate environmentally friendly properties at various stages of the R&D process. The flexibility of the pharmaceutical R&D process, which relies on balancing multiple parameters, can facilitate this integration. Additionally, certain API properties that reduce environmental risks align with common desirable application properties.

Early Integration of Environmental Aspects in the R&D Process

Environmental considerations should be incorporated early in the R&D process, during molecule screening and optimization. Availability of suitable in silico models and in vitro assays is crucial for this, with attributes such as throughput and costs determining their successful application at different process stages.

Collaboration for Sustainable Innovation

Enhanced collaboration between R&D and environmental experts, both within and outside companies, can advance the industrial application of the benign-by-design approach for APIs. Collaborative efforts spanning pharmaceutical companies, regulatory authorities, and academia are deemed highly promising. Financial, social, and regulatory incentives would further support the future design of greener APIs.

There is significant potential for incorporating environmental criteria into the parameters optimised for in drug discovery and development.

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Language
English
Authorship
Neele Puhlmann (Leuphana University of Lüneburg)
Klaus Kümmerer (Leuphana University of Lüneburg, ISC3)
Funding
Published in
European Journal of Pharmaceutical Sciences 192 (2024) 106614
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Year
Dimension
13 pp.
ISSN
0928-0987 (print)
1879-0720 (online)
DOI
Project
Project ID
Table of contents
Keywords
pharmaceuticals in the environment, APIs, environmental impact of pharmaceuticals, greener drug design, water, pharmaceutical industry
Europe
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