B2144 - CHIMICA ORGANICA APPLICATA: DAL LABORATORIO AL MERCATO

Learning outcomes

At the end of the course, the student will be able to evaluate various hypotheses for the total synthesis of active pharmaceutical ingredients (APIs) suitable for  the preparation on a large scale, based on economic criteria and normative restrictions. The student will acquire knowledge about the solvents and reagents more used for large scale productions, on the analytical investigations required for market approval, and on regulatory issues related to the scaled-up processes. The students will also acquire the critical capacity to evaluate, modify, and propose synthetic methodologies suitable for large-scale preparation of a new organic molecule. 

Course contents

1. Drug Discovery e Molecular Complexity. The challanges and complexity of drug development is directlu realte to the evolution of the drug design and teh  introduction of new modalities. 

2. Modern synthetic methodologies trends in the Pharma Industry. The discussion will be on the segment of small molecules and iterative processes like peptides. 

3. Intellectual Property. The basis of IP protection in the farmaceutical segmants will be discussed in relationship to the drug discovery and development process. 

4. Solid State. Most of the drugs are at solid state and its impact on the drug discovery and development will be discussed.

5. ICH guidelines. Analytical Challanges of drug development will be discussed. In aprticular genotoxic impurities, elemental impurities, nitrosamines etc.

6. Green Technologies, catalysis & flow chemistry. The application fo the Green Chemistry Principles as a guideline for a sustanable drug development through green metrix will be discussed.  

7. Case histories of several drugs development form bench to market. During the course e are going to discuss several drug development approaches and their evolution dring teh drug discovery and development proces.s 

Readings/Bibliography

“From Bench to Market. The Evolution of Chemical Synthesis from Discovery to Industrial Production.”; Oxford University Press: Oxford, 2000.

Specific publications will be given to the students.

Teaching methods

Frontal course with slides projected in class and commented with the help of interactive screens or blackboard. There will be up to 3 lessons by researchers coing from the Industry discussing soem modern aspects of drug discoevry and development. This is a Course for the last year of the LAurea Magistrale and the main tarrget is introdude students to modern industrial practice.

Assessment methods

Oral examination that will be directly fixed with the Professor. This flexibility for teh students is linked to the fcat that it's an examination at teh last year of the master degree.

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students ) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

Teaching tools

Copies of the slides in pdf will be provided to the students. During the Lessons several pubblications and url of key web site will be available to the students.

It is useful to remind that students cannot share or publish the slides of the course in full or in part.

Office hours

See the website of Walter Cabri