The main objective of the course is to provide knowledge on innovative formulations, both on the market and in the research and development phase. Furthermore, basic knowledge on the most common techniques for the characterization and quality control of medicines will be provided. A further objective of the course is to provide theoretical notions on technology transfer, as well as on the optimization of industrial processes for the manufacture of medicines.

Innovative pharmaceutical forms: 1. Biopharmaceutical, bioavailability, bioequivalence and controlled drug release 2. Polymers and their applications: correlations between structure and properties 3. Polymer conjugates for drug delivery 4. Nanoparticles for theranostics 5. Nanoparticles and Microparticles: methods of preparation, drug delivery and diagnostics 6. Liposomes: structure, preparation and applications 7. Vaccines and therapeutic peptides 8. Electrospinning 9. Microfluidics 10. 3D-printing Characterization techniques for quality control: 11. Dynamic light scattering (DLS) 12. Principles of rheology 13. Optical, scanning electron (SEM) and transmission (TEM) microscopy 14. Techniques for the thermal characterization of materials Industrial production of drugs. 15. Technology transfer. 16. Good manufacturing practices (GMP): the concept of quality, the Quality System, Qualification and Validation 17. Pharmaceutical packaging and sterilization 18. The Design of Experiments (DoE) for industrial processes

D1 - KNOWLEDGE, AND UNDERSTANDING. At the end of the course the student will have to demonstrate the ability to know the technologies that allow the development of innovative pharmaceutical formulations; to know the techniques for the chemical-physical characterization of pharmaceutical formulations; to know the processes related to the industrial production of drugs; to know the critical issues for obtaining the high quality required for pharmaceutical products; to know the main issues relating to the protection of intellectual property.

D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING. . At the end of the course the student will have to demonstrate the ability to classify and describe the various innovative technologies for the design of pharmaceutical formulations; to plan the necessary chemical-physical characterization path and interpret the experimental data obtained; to understand and control industrial production lines; to apply the rules of good manufacturing and good preparation; to plan actions to protect the innovative industry.

D3 - AUTONOMY OF JUDGMENT. At the end of the course, the student will have to demonstrate the ability to design innovative pharmaceutical formulations and to plan and evaluate the technological, managerial, regulatory, and safety aspects related to the industrial drug production process.

D4 - COMMUNICATION SKILLS. At the end of the course, the student must demonstrate that he can communicate and transmit the concepts and notions learned during the training activity with appropriate terms and examples.

D5 - LEARNING SKILLS. At the end of the course, the student will have to demonstrate that he can find and apply new information, compared to that provided during the training activity, necessary to design and understand the problems underlying the industrial processes for the preparation of the different types of pharmaceutical forms .industrial

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

Innovative teaching methods

FLIPPED CLASSROOM

Assessment

Written exam followed by an oral interview.

The written test will be a semi-structured test consisting of 3 open questions and 1 exercise, lasting 2 hours.

The objective of the open questions is to ascertain the mastery of basic knowledge relating to the topics of the course through the assessment of the ability to precisely define theoretical principles and fundamental concepts. The objective of the exercise is to ascertain the ability to apply knowledge, deal with complex situations, and make connections between topics covered by the teaching program.

Open questions and exercises will be evaluated with a different weight score: up to 8 points for open questions and up to 9 points for the exercise.

The oral interview, which can be quantified on average in 20 minutes, will start from a comment on the written test and will serve both to assess communication skills and to ascertain the ability to apply knowledge and concepts relating to the topics of the course.

Both the written test and the oral exam will be evaluated with a mark out of thirty. The final grade will derive from the oral exam, also taking into consideration the outcome of the written exam.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.