Technology and Pharmaceutical Legislation and Toxicology Ii
A.Y. 2023/2024
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. Basic knowledge of anatomy and physiology of the gastrointestinal tract, 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 - Written test lasting 1 hour based on 2 open-ended questions. To be admitted to the oral exam, the student must obtain a grade of at least 18/30 for both questions. Oral test concerning at least 2 questions lasting about 30 minutes.
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 - Written test lasting 1 hour based on 2 open-ended questions. To be admitted to the oral exam, the student must obtain a grade of at least 18/30 for both questions. Oral test concerning at least 2 questions lasting about 30 minutes.
Toxicology II
Course syllabus
Classroom teaching
Toxicology of the cardiovascular system
Animal toxins: origin, toxic effects and mechanisms of toxicity
Toxic effects of plants and mechanisms of toxicity
Allergy to pollens and role of air pollution
Toxicological risk of herbal products and food supplements
Toxic effects of poisonous mushrooms
Toxic effects of pesticides
Toxic effects of metals
Toxic effects of solvents and vapors
Toxic effects of susbstance abuse
Doping in sports
Consequences of alcohol abuse
Consequences of sigarette smoking
Air, soil, water pollutants
Effects on human health of air pollution
Biomonitoring of the environment
Chemical and biological weapons
Forensic toxicology
Microbiota, xenobiotics and health
Prion disease: features, mechanisms and diffusion in the environment
Food packaging: toxicological risk
Cosmetics: toxicological risk
Endocrine disruptors and human health
Classroom training
The students will receive publications or indications of websites where to study specific topics of interest within the program of the course. Students will then give a short presentation on the selected topic. The training also includes one or more technical visits to plants which have to manage an important environmental impact.
Toxicology of the cardiovascular system
Animal toxins: origin, toxic effects and mechanisms of toxicity
Toxic effects of plants and mechanisms of toxicity
Allergy to pollens and role of air pollution
Toxicological risk of herbal products and food supplements
Toxic effects of poisonous mushrooms
Toxic effects of pesticides
Toxic effects of metals
Toxic effects of solvents and vapors
Toxic effects of susbstance abuse
Doping in sports
Consequences of alcohol abuse
Consequences of sigarette smoking
Air, soil, water pollutants
Effects on human health of air pollution
Biomonitoring of the environment
Chemical and biological weapons
Forensic toxicology
Microbiota, xenobiotics and health
Prion disease: features, mechanisms and diffusion in the environment
Food packaging: toxicological risk
Cosmetics: toxicological risk
Endocrine disruptors and human health
Classroom training
The students will receive publications or indications of websites where to study specific topics of interest within the program of the course. Students will then give a short presentation on the selected topic. The training also includes one or more technical visits to plants which have to manage an important environmental impact.
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 suggested by the teacher.
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
Grinding
Mixing
Granulation
Pelletization
Drying
Compression
Coating (sugar coating and film coating)
Filtration
Solubilization
Dispersion of suspensions
Freeze drying
Packaging
Production in an aseptic environment
Overview of Innovative Medicines
Pharmaceutical isolators
Pharmaceutical workplaces
Introduction to solid/liquid/semi-solid pharmaceutical forms
Grinding
Mixing
Granulation
Pelletization
Drying
Compression
Coating (sugar coating and film coating)
Filtration
Solubilization
Dispersion of suspensions
Freeze drying
Packaging
Production in an aseptic environment
Overview of Innovative Medicines
Pharmaceutical isolators
Pharmaceutical workplaces
Teaching methods
3 CFU teaching in attendance
Teaching Resources
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
Educational website(s)
Professor(s)