Pharmaceutical Technology and Legislation I and Laboratory of Pharmaceutical Technology I
A.Y. 2024/2025
Learning objectives
The fundamental learning objective of the course is to introduce the principles of the design, preparation and control of immediate- and modified-release dosage forms, with particular reference to solid and liquid ones administered by the oral route, and those administered by the nasal and pulmonary route, either pressurized and not. The course aims to provide students with the necessary knowledge to understand the relationships between the dosage form in which the active principle is formulated, its physico-technological characteristics as well as its route of administration, and the drug availability in the biophase (bioavailability). The legislation concerning the production and quality control of industrial drug products, as well as the preparation of medicines within a pharmacy, are also addressed. The practical exercises carried out in the Laboratory module aim to consolidate the main learning objectives through the characterization of raw materials, control of the product quality, preparation of oral magistral and officinal formulae and drafting of the relevant documentation in compliance with current laws.
Expected learning outcomes
At the end of the course the student will know the role played by the dosage form in determining bioavailability of the active ingredient in the organism. In particular, the student will have the tools to identify problems related to the administration of drugs by the oral route in a form that guarantees their acceptability and therapeutic activity. Specifically, the student will know how to i) apply formulation strategies for the manufacturing of solid (powders, granules, tablets, capsules) and liquid (solutions, syrups) dosage forms, as well as aerosols; ii) conduct unitary pharmaceutical operations such as milling, mixing, granulation, drying, compression and coating; iii) assess the physical-technological quality, performance and stability of the aforementioned dosage forms; iv) manage the activities connected with the preparation and dispensing of medicines in Pharmacy.
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
Linea Unica
Responsible
Lesson period
year
Course syllabus
Pharmacetuical technology
Biopharmaceutics: dosage forms and routes of administration; bioavailability; pharmacokinetics parameters; bioequivalence; solubility and dissolution rate (Noyes-Whitney model).
Characteristics of raw materials and unitary processes for the manufacturing of solid dosage forms:
- powder properties;
- milling, mixing, granulation/pelletization, drying, tableting, coating;
- dissolution.
Oral dosage forms:
i) Immediate releae dosage forms
- formulation, manufacturing and control of solid and liquid dosage forms: powders, granules, capsules, tablets, lozenges, solutions.
ii) Modified release dosage forms
- therapeutic aims, with particular attention towards the needs of those administered by the oral route;
- matrix and reservoir systems; single and multiple unit (pellets) dosage forms;
- fast-release, prolonged-release, delayed/pulsatile-release and site-specific delivert systems.
Notes relevant to nasal and inhalation dosage forms.
Notes relevant to packaging and stability studies issues.
Legislation
Definition of drug products; manufacturing and marketing authorizations. Pharmacopoeias. Legislation relating to medicines prepared in pharmacies: good laboratory practices; labeling and pricing.
Biopharmaceutics: dosage forms and routes of administration; bioavailability; pharmacokinetics parameters; bioequivalence; solubility and dissolution rate (Noyes-Whitney model).
Characteristics of raw materials and unitary processes for the manufacturing of solid dosage forms:
- powder properties;
- milling, mixing, granulation/pelletization, drying, tableting, coating;
- dissolution.
Oral dosage forms:
i) Immediate releae dosage forms
- formulation, manufacturing and control of solid and liquid dosage forms: powders, granules, capsules, tablets, lozenges, solutions.
ii) Modified release dosage forms
- therapeutic aims, with particular attention towards the needs of those administered by the oral route;
- matrix and reservoir systems; single and multiple unit (pellets) dosage forms;
- fast-release, prolonged-release, delayed/pulsatile-release and site-specific delivert systems.
Notes relevant to nasal and inhalation dosage forms.
Notes relevant to packaging and stability studies issues.
Legislation
Definition of drug products; manufacturing and marketing authorizations. Pharmacopoeias. Legislation relating to medicines prepared in pharmacies: good laboratory practices; labeling and pricing.
Prerequisites for admission
To understand and elaborate the contents of the course, preliminary knowledge of anatomy, physiology, chemistry, physics, pharmacology and medicinal 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, passing the exams indicated in the Manifesto degli Studi and attending Laboratory courses of the previous years are the prerequisites 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, passing the exams indicated in the Manifesto degli Studi and attending Laboratory courses of the previous years are the prerequisites for admission to the practical exercises.
Teaching methods
Frontal lessons with the support of slides and self-verification activity.
Single-place laboratory exercises.
Single-place laboratory exercises.
Teaching Resources
Recommended texts:
1. Principi Di Tecnologie Farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
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.
Lessons slides and supplementary material to be downloaded from the Ariel/Teams website of the course.
Lecture notes on the exercises to be downloaded from the Ariel website, then corrected by the teacher.
1. Principi Di Tecnologie Farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
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.
Lessons slides and supplementary material to be downloaded from the Ariel/Teams website of the course.
Lecture notes on the exercises to be downloaded from the Ariel website, then corrected by the teacher.
Assessment methods and Criteria
It is assessed:
i) understanding of the topics through closed-ended questions (written test);
ii) ability to identify and present individual contents through open-ended questions (written test) and
iii) ability to relate technological, biopharmaceutical and regulatory aspects and to orally present them with the use of the appropriate terminology.
Written and oral tests deal with topics covered in the lectures and during the laboratory exercises.
Students attending the course (% of lectures established at the beginning of the course and shared with students) can take ongoing tests, each performed on lessons' time and comprising closed- and open-ended questions, and an oral test. To access the final in itinere test, students must have acquired the propaedeuticities of the course and attended the Laboratory exercises. More details are available on the Ariel/Team website of the course.
Students not attending the course need to take a written test lasting 1 hour, with closed-ended and open-ended questions, and an oral exam. To access the oral test, students must have passed the written test and acquired the laboratory's frequency certification. Results of the written test is communicated on the Ariel website of the course within 1-5 days together with the calendar for the oral tests. Written and oral tests must be taken in the same session and repeated both in the event of failure to pass the exam, unless otherwise indicated by the teacher.
For all the students, written test allows the admission to the oral test on which the final grade depends exclusively.
i) understanding of the topics through closed-ended questions (written test);
ii) ability to identify and present individual contents through open-ended questions (written test) and
iii) ability to relate technological, biopharmaceutical and regulatory aspects and to orally present them with the use of the appropriate terminology.
Written and oral tests deal with topics covered in the lectures and during the laboratory exercises.
Students attending the course (% of lectures established at the beginning of the course and shared with students) can take ongoing tests, each performed on lessons' time and comprising closed- and open-ended questions, and an oral test. To access the final in itinere test, students must have acquired the propaedeuticities of the course and attended the Laboratory exercises. More details are available on the Ariel/Team website of the course.
Students not attending the course need to take a written test lasting 1 hour, with closed-ended and open-ended questions, and an oral exam. To access the oral test, students must have passed the written test and acquired the laboratory's frequency certification. Results of the written test is communicated on the Ariel website of the course within 1-5 days together with the calendar for the oral tests. Written and oral tests must be taken in the same session and repeated both in the event of failure to pass the exam, unless otherwise indicated by the teacher.
For all the students, written test allows the admission to the oral test on which the final grade depends exclusively.
Laboratory of Pharmaceutical Technology I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Shifts:
Turno 3
Professor:
Zema Lucia
Pharmaceutical Technology and Legislation I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 9
Lessons: 72 hours
Professors:
Melocchi Alice, Zema Lucia