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Life cycle analysis within pharmaceutical process optimization and intensification: case study of active
Denise Ott1, Dana Kralisch, Ivana Denčić
1Department of Pharmaceutical Technology, Friedrich Schiller University Jena, Otto-Schott-Strasse 41, 07745 Jena (Germany). deniseott@gmx.net.
Chemsuschem
|September 25, 2014
Summary
This study optimizes pharmaceutical active pharmaceutical ingredient (API) production by shifting from batch to continuous processing and exploring new catalytic systems. Early-stage environmental assessment identifies key areas for process improvement and sustainability.
Area of Science:
- Pharmaceutical Process Development
- Green Chemistry
- Chemical Engineering
Background:
- Increasing demand for new drugs necessitates reduced pharmaceutical development timelines.
- Environmental considerations are often overlooked in early-stage active pharmaceutical ingredient (API) process development.
- Optimizing processes early can prevent costly late-stage modifications and improve sustainability.
Purpose of the Study:
- To conduct a holistic, life-cycle-based process optimization and intensification for a low-volume, high-value API.
- To evaluate environmental impacts of different process strategies, including continuous processing and alternative catalytic systems.
- To identify bottlenecks and opportunities for improvement in pharmaceutical production.
Main Methods:
- Life-cycle assessment (LCA) applied to pharmaceutical process development.
- Comparison of batch versus continuous processing for API synthesis.
- Evaluation of alternative catalytic systems for improved efficiency and environmental footprint.
- Process intensification strategies.
Main Results:
- Identified key environmental impact areas in the current pharmaceutical production process.
- Quantified the environmental benefits of transitioning to continuous manufacturing.
- Highlighted the potential of alternative catalytic systems to reduce waste and energy consumption.
Conclusions:
- Early-stage, life-cycle-based process optimization is crucial for sustainable API development.
- Continuous processing and optimized catalytic systems offer significant environmental advantages.
- This approach provides a roadmap for greener and more efficient pharmaceutical manufacturing.
Keywords:
active pharmaceutical ingredientgreen pharmacyheterogeneous catalysislife cycle assessmentprocess designMore Related Videos
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