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3. Flow synthesis of active pharmaceutical ingredients
3.1 Summary
The synthesis of active pharmaceutical ingredients (APIs) has traditionally been carried out on a large scale (up to 100 t for certain products) using a batch synthesis method. Microfluidics – here embodied by the use of microreactors – enables the switch to a flow synthesis method, notably improving enantioselectivity and limiting the formation of by-products , phenomena and properties degrading the pharmaceutical quality of the product.
Microreactors for API synthesis have...
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Flow synthesis of active pharmaceutical ingredients
Galenic formulation
Bibliography
Standards and norms
- Microfluidic devices – Interoperability requirements concerning dimensions, connections and initial classification of devices - ISO 22916 - 2022
- Automated liquid handling systems – Part 1: Vocabulary and general requirements - ISO 23783-1 - 2022
- Microfluidics – Vocabulary - ISO 10991 - 2023
- Automated liquid handling systems – Uncertainty of measurement procedures - ISO/TR 6037 - 2024
Regulations
Commission Directive (EU) 2017/1572 of September 15, 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards principles and guidelines of good manufacturing practice for medicinal products for human use (CELEX: 32017L1572)
Directory
European EMPIR project "Establishing metrology standards in microfluidic devices" (MFMET, 20NRM02): https://mfmet.eu
GDR Micro and Nanofluidics : https://www.gdrmicrofluidique.com
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