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. Physico-chemical and biopharmaceutical principles underlying the design of dosage forms

2.Modified release systems: delayed, sustained, controlled and drug targeting.

3. Release kinetics and mechanisms

4.Polymers and their applications: correlations between structure and properties.

5. Polymer conjugates for drug delivery

6.Microparticles

7.Nanoparticles

8.Nanoparticles for theranostics

9.Liposomes: structure, preparation and applications

10. Biological drugs

11.Electrospinning

12. Microfluidics

13.3D-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. Thermal characterization techniques of materials

Industrial production of drugs.

15.Packaging and packaging;

16.Product stability and stability testing

17.The Design of Experiments (DoE) for industrial processes.

18. Technology transfer.

19.Good Manufacturing Practices: the QbD (Quality by Design) approach, the pharmaceutical quality system, validation.

Physical methods in organic chemistry

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

Teaching

Frontal lessons in the classroom carried out in the traditional way supported by the projection of teaching material.

Innovative teaching methods

In addition to the frontal lessons, some lessons will be proposed in FLIPPED CLASSIROOM mode.

Attendance

Attendance at lessons is not mandatory but it is strongly recommended on a regular basis to encourage both interaction in the classroom and the acquisition of knowledge and skills.

Course books

-   Aulton's pharmaceutics - the design and manufacture of medicines, 4th ed. - Churchill Livingstone/Elsevier.

-   Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press

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.

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.

Teaching

Non-attending students can use the Moodle platform (Blended Learning UniUrb-CISDEL)

Attendance

Attendance at lessons is not compulsory but it is strongly recommended on a regular basis to encourage both interaction in the classroom and the acquisition of knowledge and skills

Course books

-   Aulton's pharmaceutics - the design and manufacture of medicines, 4th ed. - Churchill Livingstone/Elsevier.

-   Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press

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.

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.