Technology and Pharmaceutical Legislation and Toxicology Ii
A.Y. 2024/2025
Learning objectives
The aim of the course is to introduce the students to the main classes of xenobiotics (natural and synthetic molecules) exerting toxic effects on humans. Exposure conditions are examined, the toxic effects are described, and the molecular mechanisms explaining the toxicity of the different molecules are analyzed. Experimental and epidemiological data defining the risk assessment are critically analysed. The course also aims at introducing the principles underlying the production of the main conventional and modified-release pharmaceutical forms for acquiring the knowledge necessary to understand the relationships between manufacturing technologies of the different pharmaceutical forms and the risks for operators and the environment. The main specific criticalities of the technologies for the industrial preparation of pharmaceutical forms and the various methods of reducing the risks adopted will be illustrated in detail.
Expected learning outcomes
At the end of the course the student must demonstrate to possess an adequate knowledge of the toxic effects of natural and synthetic molecules and of the mechanisms explaining their toxicity. The student is also expected to be able to critically analyse toxicological issues, based on the available data: experimental, occupational and epidemiological. Student must also hold the fundamental pharmaceutical technologies for the purpose of mitigating the risks to the health of operators and to the environment associated with the development and production of medicinal products in the industrial field.
Lesson period: year
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Single session
Responsible
Lesson period
year
Prerequisites for admission
The students must have knowledge of general toxicology, organ toxicology and environmental toxicology.
The students must also have basic knowledge of thermodynamics, chemistry of small molecules and polymers for pharmaceutical use are also required.
The students must also have basic knowledge of thermodynamics, chemistry of small molecules and polymers for pharmaceutical use are also required.
Assessment methods and Criteria
Toxicology 2 - The students are asked to write the answer to four open questions on the topics discussed during the course. A score expressed in thirtieths is given to each answer. The exam is passed if the students reach the score of 18/30 in three out of the four answers and the average score of the four answers is at least 18/30.
To support the students, two partial tests are carried out during the course, on the first and the second half of the program, respectively. Each test consists of three open questions. A score expressed in thirtieths is given to each answer. Each test is passed if the students reach the score of 18/30 in two out of the three answers and the average score of the three answers is at least 18/30. The two tests are passed if the average score of the first and second test is at least 18/30.
The oral presentation given by the students during the training hours will also contribute, up to 5%, to the final mark.
Technology and pharmaceutical legislation - The examination consists of an oral test concerning at least 3 questions, lasting about 40 minutes.
To support the students, two partial tests are carried out during the course, on the first and the second half of the program, respectively. Each test consists of three open questions. A score expressed in thirtieths is given to each answer. Each test is passed if the students reach the score of 18/30 in two out of the three answers and the average score of the three answers is at least 18/30. The two tests are passed if the average score of the first and second test is at least 18/30.
The oral presentation given by the students during the training hours will also contribute, up to 5%, to the final mark.
Technology and pharmaceutical legislation - The examination consists of an oral test concerning at least 3 questions, lasting about 40 minutes.
Toxicology II
Course syllabus
Classroom teaching
Toxicology of the cardiovascular system
Animal toxins: poisonous species, toxic effects and mechanisms of toxicity
Toxicity from plants: manifestations and mechanisms of toxicity
Pollinosis and the role of air pollution
Toxicity from herbal products and dietary supplements
Intoxication from mushrooms
Pesticides
Metals
Solvents/vapors
Substances of abuse
Doping in sports
Alcohol abuse
Smoking
Pollution of air, soil, water
Health effects of air pollutants
Environmental biomonitoring
Micro and nanoplastics: impact on living organisms
Chemical and biological weapons
Forensic toxicology
Microbiota, xenobiotics, and health
Prion diseases: characteristics, mechanisms, and environmental spread.
Food packaging: toxicological risk
Cosmetics: toxicological risk
Endocrine disruptors and human health
Classroom training
Students give short presentations on in-depth topics relevant to the teaching program. Students are supported in finding the literature material on which to base their presentations.
As part of the training, one or more visits are organized to facilities that address important environmental issues.
Toxicology of the cardiovascular system
Animal toxins: poisonous species, toxic effects and mechanisms of toxicity
Toxicity from plants: manifestations and mechanisms of toxicity
Pollinosis and the role of air pollution
Toxicity from herbal products and dietary supplements
Intoxication from mushrooms
Pesticides
Metals
Solvents/vapors
Substances of abuse
Doping in sports
Alcohol abuse
Smoking
Pollution of air, soil, water
Health effects of air pollutants
Environmental biomonitoring
Micro and nanoplastics: impact on living organisms
Chemical and biological weapons
Forensic toxicology
Microbiota, xenobiotics, and health
Prion diseases: characteristics, mechanisms, and environmental spread.
Food packaging: toxicological risk
Cosmetics: toxicological risk
Endocrine disruptors and human health
Classroom training
Students give short presentations on in-depth topics relevant to the teaching program. Students are supported in finding the literature material on which to base their presentations.
As part of the training, one or more visits are organized to facilities that address important environmental issues.
Teaching methods
10 CFU: 8 CFU teaching and 2 CFU training, in attendance
Teaching Resources
The teacher provides power point files on Ariel webpage summarizing each lesson. The files have to be integrated with student's notes and scientific articles cited in the power point files.
Reference text: Casarett & Doull's. Toxicology, McGraw-Hill.
Reference text: Casarett & Doull's. Toxicology, McGraw-Hill.
Technology and Pharmaceutical Legislation
Course syllabus
Introduction to the course
Introduction to solid/liquid/semi-solid pharmaceutical forms.
Main techniques for preparing solid pharmaceutical forms and problems for the operator and the environment: grinding, mixing, granulation, pelletization, drying, compression, coating (sugar coating and film filming), freeze-drying.
Main techniques for preparing liquid pharmaceutical forms and problems for the operator and the environment: filtration, solubilization, dispersion of suspensions.
Packaging technologies for pharmaceutical forms.
Technical and safety aspects in production in an aseptic environment.
Types and methods of use of pharmaceutical isolators.
Overview of innovative medicines and risks for the operator and the environment in their production.
Classification and management of pharmaceutical workplaces according to the types of pharmaceutical products.
Introduction to solid/liquid/semi-solid pharmaceutical forms.
Main techniques for preparing solid pharmaceutical forms and problems for the operator and the environment: grinding, mixing, granulation, pelletization, drying, compression, coating (sugar coating and film filming), freeze-drying.
Main techniques for preparing liquid pharmaceutical forms and problems for the operator and the environment: filtration, solubilization, dispersion of suspensions.
Packaging technologies for pharmaceutical forms.
Technical and safety aspects in production in an aseptic environment.
Types and methods of use of pharmaceutical isolators.
Overview of innovative medicines and risks for the operator and the environment in their production.
Classification and management of pharmaceutical workplaces according to the types of pharmaceutical products.
Teaching methods
3 CFU teaching in attendance
Teaching Resources
Reference texts: P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006); L.Fabris, A.Rigamonti, La fabbricazione industriale dei medicinali, Esculapio, Bologna (2008); L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986).
Technology and Pharmaceutical Legislation
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor:
Cerea Matteo
Toxicology II
BIO/14 - PHARMACOLOGY - University credits: 10
Practicals: 32 hours
Lessons: 64 hours
Lessons: 64 hours
Professor:
Chiesa Giulia Maria Carola
Professor(s)