Síntese e Caracterização de Substâncias Activas

Objectives

To provide general information and knowledge on practical active pharmaceutical ingredients (API) industrial synthesis. The focus will be on API industrial synthesis (route discovery and selection, hazards and process development) and characterization (methods and specifications).

Syllabus

I. Synthetic route discovery and selection - The evolution of chemical synthesis from laboratory to industrial scale; The launching process - Laboratorial versus Industrial synthesis - Synthetic route discovery and selection; Patents II. Process safety - 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 development of a synthetic step: the chemical transformation, the work-up, the isolation and purification of the product; Polymorphism and chiral synthesis IV. Analysis - In-process control and Active Pharmaceutical Ingredient characterization - Typical analysis of an API - API stability and specifications

Prerequisites

Basic knowledge in Organic Chemistry.

Cross Competence Component

Knowledge of active pharmaceutical ingredient (API) synthesis is essential in a pharmaceutical engineering course because it connects chemical process understanding with real-world drug production. It enables students to design efficient, safe, and scalable processes for creating the core components of medications. This knowledge is critical for ensuring product quality, regulatory compliance, and innovation in pharmaceutical manufacturing.

Ethical Principles

All members of a group are responsible for the group's work. In any assessment, every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.