Pharmaceutical Technology and Legislation, with Laboratory of Pharmaceutical Technology
A.Y. 2025/2026
Learning objectives
The course is aimed at providing theoretical and practical fundamentals relating to the preparation and control of conventional pharmaceutical dosage forms. The tools necessary to understand the relationships between the physico-chemical characteristics of the active molecules, the route of administration and the bioavailability will be provided. Elements of legislation of drug products will also be covered. The Pharmaceutical Technology laboratory aims to provide students with the physico-chemical basics for the preparation and control of immediate-release dosage forms.
Expected learning outcomes
The student will learn the physico-chemical principles underlying pharmaceutical technology and will acquire fundamental skills for the formulation and preparation of the various immediate-release dosage forms.
Lesson period: year
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Linea Unica
Responsible
Lesson period
year
Course syllabus
Pharmaceutical technology
Dosage forms and drug products: definition and classifications.
Biopharmaceutics: general concepts of liberation/dissolution, bioavailability and bioequivalence - Main bioavailability issues related to specific districts, such as oral, parenteral, topical and inhalation routes of administration.
Solid dosage forms: powders and their processing - Unit operations (grinding, mixing, granulation and drying) - Formulation, preparation, properties and controls of sachets, capsules, tablets and lozanges/gummies.
Liquid dosage forms (solutions, suspensions and emulsions): formulation, preparation, properties and controls.
Pharmaceutical water; sterile dosage forms (parenteral preparations and eye drops): formulation, preparation, properties and controls.
Semi-solid dosage forms: formulation, preparation, properties and controls.
Other dosage forms, such as rectal, nasal and pulmonary.
Sterility. Stability of medicinal products.
Pharmaceutical Technology Laboratory
Formulation, preparation and control of solid (powders, granules, capsules, tablets, lozanges and gummies), liquid (solutions, emulsions and suspensions) and semisolid (creams, ointments, gels, pastes and suppositories) dosage forms, with a focus on pharmacopoeia methods for quality assessment.
1CFU of laboratory activities will be devoted to develop students' ability to handle, process and understand experimental data acquired in the characterisation and control activities of raw materials, physical systems and formulations performed in the laboratory. This activity will exploit innovative teaching methods and will be conducted remotely, also working in small groups, always with the guidance and support of the lecturer.
Legislation
Definition of medicinal product - administrative classification - development of medicinal products - prior marketing authorisations - Pharmacopoeias
Dosage forms and drug products: definition and classifications.
Biopharmaceutics: general concepts of liberation/dissolution, bioavailability and bioequivalence - Main bioavailability issues related to specific districts, such as oral, parenteral, topical and inhalation routes of administration.
Solid dosage forms: powders and their processing - Unit operations (grinding, mixing, granulation and drying) - Formulation, preparation, properties and controls of sachets, capsules, tablets and lozanges/gummies.
Liquid dosage forms (solutions, suspensions and emulsions): formulation, preparation, properties and controls.
Pharmaceutical water; sterile dosage forms (parenteral preparations and eye drops): formulation, preparation, properties and controls.
Semi-solid dosage forms: formulation, preparation, properties and controls.
Other dosage forms, such as rectal, nasal and pulmonary.
Sterility. Stability of medicinal products.
Pharmaceutical Technology Laboratory
Formulation, preparation and control of solid (powders, granules, capsules, tablets, lozanges and gummies), liquid (solutions, emulsions and suspensions) and semisolid (creams, ointments, gels, pastes and suppositories) dosage forms, with a focus on pharmacopoeia methods for quality assessment.
1CFU of laboratory activities will be devoted to develop students' ability to handle, process and understand experimental data acquired in the characterisation and control activities of raw materials, physical systems and formulations performed in the laboratory. This activity will exploit innovative teaching methods and will be conducted remotely, also working in small groups, always with the guidance and support of the lecturer.
Legislation
Definition of medicinal product - administrative classification - development of medicinal products - prior marketing authorisations - Pharmacopoeias
Prerequisites for admission
To understand and elaborate the contents of the course, preliminary knowledge of anatomy, physiology, physics and biostatistics, pharmacology and chemistry is necessary. Consistently, the preliminary examinations indicated in the Manifesto degli Studi were selected.
In order to face the mandatory practical exercises profitably and safely, a basic ability and knowledge of the risks associated with the handling of chemical substances are necessary. For this reason, attending Laboratory courses of previous years indicated in the Manifesto degli Studi is a prerequisite for admission to the practical exercises.
In order to face the mandatory practical exercises profitably and safely, a basic ability and knowledge of the risks associated with the handling of chemical substances are necessary. For this reason, attending Laboratory courses of previous years indicated in the Manifesto degli Studi is a prerequisite for admission to the practical exercises.
Teaching methods
Frontal lessons with the support of slides; insights and self-verification activities on MyAriel.
Single-place laboratory exercises.
Single-place laboratory exercises.
Teaching Resources
1. Paolo Caliceti. Tecnologia Farmaceutica Zanichelli, ed. 2025
2. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Le Basi Chimico-Fisiche Della Tecnologia Farmaceutica. AT Florence, D Attwood. Edises, 2002.
4. Legislazione farmaceutica. P. Minghetti. Casa Editrice Ambrosiana, ed. X, 2021.
Lecture slides can be downloaded from the course's MyAriel site and additional material can be downloaded from the digital library on the University's website.
Handouts prepared by the lecturers for the laboratory exercises, to be downloaded from the MyAriel website, completed and corrected during the activities.
2. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Le Basi Chimico-Fisiche Della Tecnologia Farmaceutica. AT Florence, D Attwood. Edises, 2002.
4. Legislazione farmaceutica. P. Minghetti. Casa Editrice Ambrosiana, ed. X, 2021.
Lecture slides can be downloaded from the course's MyAriel site and additional material can be downloaded from the digital library on the University's website.
Handouts prepared by the lecturers for the laboratory exercises, to be downloaded from the MyAriel website, completed and corrected during the activities.
Assessment methods and Criteria
The comprehension of the contents of the course, the ability to present them concisely, the acquisition of a technical-scientific language appropriate to the professional activity of the degree and the ability to link the biopharmaceutical, formulation and production aspects of each type of dosage form and route of administration discussed are tested by means of a written test containing open-ended questions.
The examination can be divided into two ongoing tests, the first one given in the break between the first and second semester and the second one at the end of the course, or it can be taken in a single call after the end of the course. In detail,
two ongoing tests: each written test lasts 3 hours and involves 4 open questions, one of which is linked to laboratory activities; each question can be given a maximum mark of 8, except for those linked to laboratory activities, which can be given a maximum mark of 6; to pass each test the student must achieve sufficiency (18), to merit laude he/she must achieve a final average mark of 30 and have acquired a merit note during laboratory activities;
single-call final exam: the written test lasts 3 hours and includes 6 open questions, two of which are related to laboratory activities; each question can be given a maximum score of 5; to pass the test the student must achieve sufficiency (18), to deserve the distinction he/she must achieve a 30 mark and have acquired a merit note during laboratory activities.
The examination can be divided into two ongoing tests, the first one given in the break between the first and second semester and the second one at the end of the course, or it can be taken in a single call after the end of the course. In detail,
two ongoing tests: each written test lasts 3 hours and involves 4 open questions, one of which is linked to laboratory activities; each question can be given a maximum mark of 8, except for those linked to laboratory activities, which can be given a maximum mark of 6; to pass each test the student must achieve sufficiency (18), to merit laude he/she must achieve a final average mark of 30 and have acquired a merit note during laboratory activities;
single-call final exam: the written test lasts 3 hours and includes 6 open questions, two of which are related to laboratory activities; each question can be given a maximum score of 5; to pass the test the student must achieve sufficiency (18), to deserve the distinction he/she must achieve a 30 mark and have acquired a merit note during laboratory activities.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 12
Single bench laboratory practical: 64 hours
Lessons: 64 hours
Lessons: 64 hours
Professors:
Franze' Silvia, Gennari Chiara Grazia Milena, Musazzi Umberto Maria, Selmin Francesca, Zema Lucia
Shifts:
Professors:
Gennari Chiara Grazia Milena, Zema Lucia
Turno 2
Professor:
Gennari Chiara Grazia MilenaTurno 4
Professor:
Selmin FrancescaProfessor(s)
Reception:
by appointment
Dept. Pharmaceutica Sciences - via G. Colombo, 71