Pharmaceutical Technology and Legislation I and Laboratory of Pharmaceutical Technology I
A.Y. 2019/2020
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 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 MZ
Course currently not available
Laboratory of Pharmaceutical Technology I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Pharmaceutical Technology and Legislation I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 9
Lessons: 72 hours
Linea Unica
Responsible
Lesson period
year
Course syllabus
Biopharmaceutics: dosage forms and routes of administration; bioavailability; pharmacokinetic parameters; bioequivalence; solubility and dissolution rate (Noyes-Whitney model).
Oral dosage forms:
- powder properties;
- unitary processes (milling, mixing, granulation/pelletization, drying, tableting, coating, dissolution);
- formulation, manufacturing and control of solid and liquid immediate-release dosage forms: powders, granules, capsules, tablets, lozenges, solutions.
Modified-release dosage forms:
- rationale, particularly with reference tooral delivery systems;
- matrix and reservoir systems; single- and multiple-unit (pellets) dosage forms.
Basic aspects of nasal and inhalation dosage forms.
Basic aspects of packaging and stability studies.
Definition of drug products; manufacturing and marketing authorizations. Pharmacopoeias. Legislation relevant to galenic preparations: good compounding practices; labeling and pricing.
Oral dosage forms:
- powder properties;
- unitary processes (milling, mixing, granulation/pelletization, drying, tableting, coating, dissolution);
- formulation, manufacturing and control of solid and liquid immediate-release dosage forms: powders, granules, capsules, tablets, lozenges, solutions.
Modified-release dosage forms:
- rationale, particularly with reference tooral delivery systems;
- matrix and reservoir systems; single- and multiple-unit (pellets) dosage forms.
Basic aspects of nasal and inhalation dosage forms.
Basic aspects of packaging and stability studies.
Definition of drug products; manufacturing and marketing authorizations. Pharmacopoeias. Legislation relevant to galenic preparations: good compounding 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, preparatory examinations were indicated in the Manifesto degli Studi.
In order to face the mandatory practicals profitably and safely, a basic ability and knowledge of the risks associated with laboratory activities, e.g. 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 practicals.
In order to face the mandatory practicals profitably and safely, a basic ability and knowledge of the risks associated with laboratory activities, e.g. 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 practicals.
Teaching methods
Frontal lessons with the aid of slides. Single-bench practicals.
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 website of the course.
Practical workbook to be downloaded from the Ariel website of the course, which will be returned corrected by the teacher at the end of the course.
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 website of the course.
Practical workbook to be downloaded from the Ariel website of the course, which will be returned corrected by the teacher at the end of the course.
Assessment methods and Criteria
The examination is aimed at assessing: 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) oral presentation using the appropriate terminology of 2/3 topics, which connect different aspects of the programme. Written and oral tests deal with topics covered in the lectures and during the practicals.
Students attending the course can take 3 ongoing written tests, each comprising 20 closed-ended questions and 5 open-ended questions, and a final oral test, having passed at least 2 of the ongoing tests. The oral test is accessed through reserved sessions after having acquired the prerequisites of the course and attended the practicals.
Students not attending the course need to take a written test lasting 1 hour, with 20 closed-ended questions and 3 open-ended questions, and the oral test. To access the oral test, students must have passed the written test and acquired the laboratory certificate of attendance. Results of the written test are communicated on the Ariel website of the course within a few days together with the planning of the oral tests. Written and oral tests must be taken in the same session and repeated both in the event of failure, unless otherwise indicated by the teacher.
Students attending the course can take 3 ongoing written tests, each comprising 20 closed-ended questions and 5 open-ended questions, and a final oral test, having passed at least 2 of the ongoing tests. The oral test is accessed through reserved sessions after having acquired the prerequisites of the course and attended the practicals.
Students not attending the course need to take a written test lasting 1 hour, with 20 closed-ended questions and 3 open-ended questions, and the oral test. To access the oral test, students must have passed the written test and acquired the laboratory certificate of attendance. Results of the written test are communicated on the Ariel website of the course within a few days together with the planning of the oral tests. Written and oral tests must be taken in the same session and repeated both in the event of failure, unless otherwise indicated by the teacher.
Laboratory of Pharmaceutical Technology I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Shifts:
Turno 1
Professor:
Zema LuciaTurno 2
Professor:
Gennari Chiara Grazia Milena
Pharmaceutical Technology and Legislation I
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 9
Lessons: 72 hours
Professor:
Zema Lucia
Shifts:
-
Professor:
Zema Lucia