Master in Pharmaceutical Engineering

Active Pharmaceutical Ingredients (Api): Synthesis and Analysis



Learning outcomes

To provide general information and knowledge on practical API industrial organic chemistry features:

  1. Industrial synthesis of API?s (route discovery and selection, hazards and process development)
  2. Analysis and characterization of API?s (methods and specifications).


I Synthetic route discovery and selection
- The evolution of chemical synthesis from laboratory to industrial scale. The drug launching process.
- Laboratorial versus Industrial synthesis
- Organic drug synthesis strategy.The ideal process
- Synthetic route discovery and selection. Patents
- Route selection methods

II Hazards in industrial synthesis
- Major areas: toxicity, fire/explosion and chemical reaction hazards. Major accident causes
- Hazards in process development and scale-up. Process safety
- Thermal hazards: thermal stability and explosiveness of compounds and mixtures
- Heat and gas generation. Process abnormalities

III Process Development and scale-up (batch)
- Main strategy: individual step study, integration of individual steps and global strategy
- Individual step development: the chemical transformation, the work-up, the isolation and purification of the product.

IV Analysis
- In-process control and API characterization
- Polymorphism analysis, enantiomeric purity