Formulation and Legislation of Health Products
A.Y. 2024/2025
Learning objectives
The purpose of the course is to provide basics concepts on formulation, preparation/production and quality control health products, particularly with regard to dietary supplements, and on current legislation and regulations thereof.
Expected learning outcomes
At the end of the course the student will acquire skills to prepare health products such as dietary supplements, according to the current legislation and regulations. Training in the lab will consolidate the theoretical notions previously provided.
Lesson period: First semester
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
First semester
Course syllabus
- Introduction
- Dosage forms. Definition and classification. Administration routes
- Biopharmaceutics: LADME processes, descriptive pharmacokinetic parameters, bioavailability, formulation and manufacturing aspects that affect oral bioavailability, Noyes -Whitney's law, absolute and relative bioavailability, bioequivalence
- Powders: properties and characterization
- Grinding, mixing, granulation: rationale, processes, equipment
- Compression: rationale, compression physics, types and setting of tablet presses
- Formulation, manufacturing and testing of oral solid dosage forms: tablets, capsules, sachets, cachets, lozenges, pastilles, chewing gums
- Coating of solid dosage forms: rationale, processes, equipment
- Modified-release dosage forms for oral administration
- Formulation, manufacturing and testing of liquid oral dosage forms
- Stability of solid and liquid dosage forms
- Dosage forms. Definition and classification. Administration routes
- Biopharmaceutics: LADME processes, descriptive pharmacokinetic parameters, bioavailability, formulation and manufacturing aspects that affect oral bioavailability, Noyes -Whitney's law, absolute and relative bioavailability, bioequivalence
- Powders: properties and characterization
- Grinding, mixing, granulation: rationale, processes, equipment
- Compression: rationale, compression physics, types and setting of tablet presses
- Formulation, manufacturing and testing of oral solid dosage forms: tablets, capsules, sachets, cachets, lozenges, pastilles, chewing gums
- Coating of solid dosage forms: rationale, processes, equipment
- Modified-release dosage forms for oral administration
- Formulation, manufacturing and testing of liquid oral dosage forms
- Stability of solid and liquid dosage forms
Prerequisites for admission
Knowledge of fundamentals of mathematics, chemistry and pharmacognosy is required.
Teaching methods
Classes and single-bench laboratory practicals with compulsory attendance.
Teaching Resources
- Class slides available on Ariel website
- Handout of laboratory practicals
- Recommended textbooks (Principi di tecnologia farmaceutica, P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale, Casa Editrice Ambrosiana - Zanichelli; Tecnologie farmaceutiche, M.E. Aulton, K.M.G. Taylor Ed.s, Casa Editrice Hoepli; Legislazione farmaceutica, P. Minghetti, Casa Editrice Ambrosiana - Zanichelli)
- Handout of laboratory practicals
- Recommended textbooks (Principi di tecnologia farmaceutica, P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale, Casa Editrice Ambrosiana - Zanichelli; Tecnologie farmaceutiche, M.E. Aulton, K.M.G. Taylor Ed.s, Casa Editrice Hoepli; Legislazione farmaceutica, P. Minghetti, Casa Editrice Ambrosiana - Zanichelli)
Assessment methods and Criteria
Final examination consists of a written and an oral test about the topics covered during classes and laboratory practicals. The oral test is accessed after the written one has been passed. The written test comprises 3 open questions on general topics covered in classes (time available about 60 minutes, outcome of the written test and schedule of the oral one notified in two days). The oral test comprises 2 to 3 more in-depth specific questions on related topics. The final score, expressed out of thirty, takes account of the scores from both tests.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 16 hours
Lessons: 40 hours
Lessons: 40 hours
Professors:
Maroni Alessandra, Moutaharrik Saliha
Educational website(s)
Professor(s)
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71