OVERVIEW

The General Pharmacology teaching module will cover topics related to the study of the mechanisms of action of drugs and all the factors that influence their effects on humans. The Pharmacognosy teaching module proposes to characterise the main derivatives of natural origin, reviewing their active constituents, the therapeutic/toxic effects they exert both at the cellular level and in the various apparatuses and systems of the body: central nervous, gastroenteric, cardiovascular, genitourinary, respiratory, immune and skin systems, describing the pharmacological basis of their therapeutic use and the molecular mechanisms of their effects.

AIMS AND CONTENT

LEARNING OUTCOMES

The General Pharmacology teaching module aims at providing students with a solid foundation regarding the definition of a drug and everything related to pharmacological disciplines, the principles of pharmacokinetics and pharmacodynamics, the factors influencing the variability of drug response and the main mechanisms and effects of drug-drug interactions. All aspects of drug development processes from design to the post-marketing phase will also be covered.

With regard to the Pharmacognosy teaching module, skills will be provided on the general principles of pharmacognosy, the main plant, animal and mineral drugs, with particular reference to those in the European and Italian Pharmacopoeia.

AIMS AND LEARNING OUTCOMES

Training objectives in pharmacokinetics will address qualitative and quantitative concepts related to ADME processes, i.e. the set of events that bring a drug into the human body (Absorption), distribute it to the various organs and tissues (Distribution), bio-transform it (Metabolism) and remove it from the body (Elimination). The educational objectives of pharmacodynamics will address the study of how drugs interact with the human body, with a focus on the mechanisms of drug action (e.g. interactions with receptors, enzymes, transporters, etc.), dose-effect relationships, duration and intensity of therapeutic and adverse effects, as well as the potency and efficacy of drugs. The study of variability in drug response aims at identifying genetic and non-genetic factors that may modify the effects expected following the administration of a drug, including drug-drug interactions. The educational objectives of the pharmacognosy module are: i) to provide the concepts and basics for the identification and knowledge of derivatives of natural origin, in particular plant, mineral and animal, ii) to discuss the pharmacological (pharmacokinetic and pharmacodynamic aspects) and toxicological effects of their active constituents, iii) to evaluate their therapeutic use in the clinic and their potential use in industry and research.

PREREQUISITES

Contact the teacher for further information not included in the teaching sheet.

TEACHING METHODS

The General Pharmacology teaching module comprises 24 lectures of an average duration of 2 hours with active learning techniques that involve students with questions and scientific reasoning. During the lectures, the topics covered in the programme will be explained in full detail.

With regard to the Pharmacognosy module, the programme will be delivered entirely through 20 lectures lasting an average of 2 hours, with active learning techniques involving students with questions and scientific reasoning. During the lectures, the topics covered in the programme will be explained in full detail. The teaching material used during the lectures will be accessible on the AulaWeb portal by means of a registration key.

The teaching material used during the lectures will be accessible on the AulaWeb portal by means of a registration key. In the event of particular problems that do not allow for face-to-face teaching (e.g. weather emergencies or other emergency conditions), the lectures may also be conducted electronically using the Microsoft Teams online platform. The lecturer will promptly inform students of any changes via the AulaWeb teaching website and the DIFAR website.

SYLLABUS/CONTENT

GENERAL PHARMACOLOGY MODULE

Introduction to pharmacology and general concepts.

Definition of drug. Specific and non-specific effects of drugs. Constituents of drug, classification and nomenclature of drugs, therapeutic, toxic, placebo and nocebo effects; equivalent drugs. The development of a drug and references to the different branches of pharmacology. The different phases that characterise drug development (Preclinical phases, clinical phases and post-marketing phases). Definitions and outlines of pharmacognosy, pharmacovigilance, pharmacoepidemiology, pharmacoeconomics, digital pharmacology, toxicology, pharmacogenetics and pharmacogenomics.

Pharmacokinetics.Pharmaceutical phase. Basic principles and mechanisms of drug passage across biological membranes. Drug routes of administration and factors influencing absorption. Drug distribution and binding to plasma and tissue proteins; factors influencing distribution. Drug metabolism: phase I and phase II reactions. Factors influencing metabolism. Drug elimination routes and factors influencing elimination. Clinical pharmacokinetics: mono- and bicompartmental models. Bioavailability. Apparent volume of distribution, clearance and plasma half-life. Single and repeated dose kinetics. Attack and maintenance doses. Pharmacodynamics.Mechanisms of drug action. Basic principles and quali-quantitative aspects of drug-receptor interaction. Drug-receptor interaction phenomena and the concept of binding affinity and selectivity. Receptor theories: occupational theory, intrinsic activity theory, two-stage model theory and allosteric theory. Total, partial and reverse agonists. Concept of potency, efficacy and safety. Competitive, non-competitive antagonists and allosteric modulators. Synergy and additivity. Dose/concentration-response curves, desensitisation, tolerance, receptor up- and down-regulation. Receptors/reserve transporters. Receptors: classification, macromolecular structure and signal transduction systems. Examples of the main receptor subtypes. Ion channels and the mechanisms regulating calcium ion equilibria. Membrane transporters.

Variability of drug response.Variability and factors influencing drug response - possible applications for simulated pharmacy exercises. Predictable and unpredictable factors. Individual variability. Pharmacology of gender, in the elderly, children and overweight people. Genetic alterations, polymorphisms and variability of response to famaci. Variability of response to repeated administration: allergy, tolerance, tachyphylaxis, idiosyncrasy and adverse reactions in general. Pharmacoresistance.

Drug-drug interactions.The importance and problems of drug-drug interaction studies. Concept of clinically relevant interaction. Mechanisms of drug-drug, pharmacokinetic and pharmacodynamic interactions. Hints of drug-drug interactions with herbal products. Hints of drug-food interactions.

RECOMMENDED READING/BIBLIOGRAPHY

- Farmacognosia e Fitoterapia (Mazzanti, Dell’Aglio, Izzo) PICCIN EDITORE

- Farmacognosia. Botanica, chimica e farmacologia delle piante medicinali, (F. Capasso); SPRINGER EDITOR.

- Fondamenti di Farmacognosia e Fitoterapia (Galeotti, Mazzanti, Serafini); EDRA EDITOR

TEACHERS AND EXAM BOARD

Exam Board

MARCO MILANESE (President)

TIZIANA BONIFACINO

CHIARA CERVETTO (Substitute)

ERNESTO FEDELE (Substitute)

MASSIMO GRILLI (Substitute)

GUENDALINA OLIVERO (Substitute)

ANNA MARIA PITTALUGA (Substitute)

LUCA RAITERI (Substitute)

CAROLA TORAZZA (Substitute)

LESSONS

LESSONS START

The timetable for this course can be found at: EasyAcademy Portal.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The examination is divided into modules and for both will be oral. The examination is conducted by the course leader assisted by a commissioner (if necessary, the examination is conducted by the course leader and a doctoral student/assignee, recognised as an Expert in the Subject by the Degree Course Council) and lasts from 20 to a maximum of 40 minutes. The examination questions cover all the topics addressed during the lectures and allow the board to check the achievement of the teaching objectives.

ASSESSMENT METHODS

The final grade will take into account the level of preparation, the ability to reason and correlate between the different topics of the programme and the appropriate scientific language used during the interview. If the assessment criteria are not sufficiently met, the student will be rejected and invited to study in greater depth, with further explanations from the lecturer if necessary.

The examination will specifically assess (a) the level of preparation and notions acquired, (b) the ability to associate compounds of natural origin with their mechanism of action and correct therapy according to therapeutic indications, (c) the ability to link the various topics, reasoning and use of professionally appropriate language. In detail, a mark between: - 18 and 21 will indicate a modest knowledge of the topics covered and a sufficient ability to place the knowledge in the correct clinical context; - 22 and 24 will indicate a sufficient knowledge of the topics covered, an adequate ability to address the topics transversely and to place the knowledge in clinical context; - 25 and 27 will indicate a good knowledge of the topics covered, a good ability to address the topics transversely and to place the knowledge in context and more than good ability to place the knowledge for therapeutic use; - 28 and 30 will indicate an excellent knowledge of the topics covered, an excellent ability to approach the topics transversally and to place knowledge in context and an excellent ability to place knowledge for therapeutic use; Honours will be awarded if the student distinguishes himself/herself through a thorough knowledge of the topics covered in the course.

Exam schedule

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet.