The course aims to provide knowledge and skills to: a) understand the fundamental principles of pharmaceutical preformulation, including the concepts of chemical-physical and biological properties of active substances and excipients; b) analyze the characteristics of active substances and excipients to determine compatibility, stability, and solubility in relation to the desired pharmaceutical form; c) identify the main challenges of preformulation, such as stability, solubility, and bioavailability issues, and develop strategies to overcome them; d) develop preformulation schemes that optimize the pharmaceutical properties and stability of future formulations.

Pharmaceutical Formulation and Modern Drug Development: definitions; pharmacopoeia; socioeconomics.

Biopharmaceutics and Pharmacokinetics: The LADME system; bioavailability and bioequivalence; biopharmaceutic classification system (BCS).

Drug Release: General principles of diffusion; solubility and dissolution; drug release via diffusion through a matrix; controlled-release systems based on osmotic pressure.

Mechanical and Rheological Properties of Materials: Behavior under static stress; fluid rheology.

Physicochemical Properties of Solids: Properties of the solid state; thermal behavior of solid materials; shape and size determination of powders; derived properties of solids.

Pharmaceutical Physics of Dispersed Systems: Thermodynamics; optical properties; colloidal dispersions; emulsions; analytical methods for quality control.

Pharmaceutical Development: Development process scheme; International Conference on Harmonisation (ICH); Quality by Design (QbD); tools of pharmaceutical QbD.

Excipients: General aspects; water and hydrophilic liquids; lipophilic excipients; inorganic excipients; sugars and polyols; polymers; surfactants; organoleptic excipients; antioxidants.

There are no prerequisite requirements.

D1 – KNOWLEDGE AND UNDERSTANDING SKILLS. At the end of the course, the student will be able to demonstrate an in-depth knowledge of the fundamental principles related to the formulation and development of medicines. Specifically, they will understand biopharmaceutical and pharmacokinetic principles, mechanisms of release and absorption, as well as the properties of solid and colloidal materials used in the pharmaceutical field. Additionally, they will be capable of applying quality control methodologies and addressing pharmaceutical design aspects, with particular attention to excipients and development techniques that conform to international standards.

D2 – APPLYING KNOWLEDGE AND UNDERSTANDING. By the end of the course, the student will demonstrate the ability to utilize the acquired knowledge on pharmaceutical formulation principles, pharmacokinetics, release systems, and material properties to design and optimize pharmaceutical products, ensuring the quality, safety, and efficacy of medicines through the use of appropriate techniques and methodologies.

D3 – JUDGMENT AUTONOMY. At the conclusion of the course, the student will be able to make formulation choices based on objective and measurable data, as well as evaluate the implications and outcomes of pre-formulation studies regarding the characteristics of the pharmaceutical form.

D4 – COMMUNICATIVE SKILLS. By the end of the course, the student will demonstrate the ability to communicate and convey concepts and knowledge acquired during the training activity using appropriate terminology and suitable examples.

D5 – CAPACITY TO LEARN. At the end of the course, the student will demonstrate the ability to identify and apply new information beyond what was provided during the training activity, in order to design and analyze the fundamental issues of the pharmaceutical pre-formulation processes.

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

Support activities are not scheduled.

Teaching

Traditional classroom lectures complemented by the projection of educational materials.

Innovative teaching methods

Flipped lessons

Debate

Attendance

Attendance to the lessons is not mandatory but is highly recommended to be regular in order to promote both classroom interaction and the acquisition of knowledge and skills.

Course books

Tecnologia Farmaceutica a cura di Paolo Caliceti - CEA (Casa Editrice Ambrosiana)

Additional in-depth texts:

• Aulton M.E. -  Tecnologie farmaceutiche - Progettazione e allestimento dei medicinali - EDRA
• Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press
• Ansel H. - Principi di calcolo farmaceutico - EDRA

Assessment

Written exam followed by an oral interview.

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

The aim of the open-ended questions is to assess the knowledge of basic concepts related to the course topics by evaluating the ability to define theoretical principles and fundamental concepts precisely. The objective of the exercise is to evaluate the ability to apply knowledge, handle complex situations, and establish connections between topics covered in the course program.

Open-ended questions and the exercise will be scored with different weightings: up to 8 points for the open-ended questions and up to 9 points for the exercise.

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.

Teaching

Non-attending students can use the Moodle platform (Blended Learning UniUrb-CISDEL) to access the teaching materials provided by the instructor.

Attendance

Attendance at lessons is not mandatory but is highly recommended on a regular basis to promote both classroom interaction and the acquisition of knowledge and skills.

Course books

Tecnologia Farmaceutica a cura di Paolo Caliceti - CEA (Casa Editrice Ambrosiana)

Additional in-depth texts:

• Aulton M.E. -  Tecnologie farmaceutiche - Progettazione e allestimento dei medicinali - EDRA
• Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press
• Ansel H. - Principi di calcolo farmaceutico - EDRA

Assessment

Written exam followed by an oral interview.

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

The aim of the open-ended questions is to assess the knowledge of basic concepts related to the course topics by evaluating the ability to define theoretical principles and fundamental concepts precisely. The objective of the exercise is to evaluate the ability to apply knowledge, handle complex situations, and establish connections between topics covered in the course program.

Open-ended questions and the exercise will be scored with different weightings: up to 8 points for the open-ended questions and up to 9 points for the exercise.

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.