Formulation and legislation of health products

A.Y. 2021/2022
6
Max ECTS
56
Overall hours
SSD
CHIM/09
Language
Italian
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.
Course syllabus and organization

Single session

Responsible
Lesson period
First semester
More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
Course syllabus
- Introduction
- Dosage forms. Definition and classification. Administration routes
- Biopharmaceutics: LADME processes, descriptive pharmacokinetic parameters, absolute and relative bioavailability
- Powders: properties and characterization
- Unitary operations (grinding, mixing and drying): rationale, mechanisms, equipment
- Granulation: rationale, mechanisms, equipment
- Compression: compression physics, equipment setting
- Formulation, preparation and testing of solid dosage forms: tablets, capsules, lozenges, chewing gums.
- Coating of solid dosage forms
- Modified-release dosage forms for oral administration
- Formulation and production variables that affect bioavailability. Solid State. Noyes -Whitney's Equation
- Formulation and preparation of liquid oral dosage forms
- Stability of solid and liquid dosage forms
Prerequisites for admission
Attendees need to be acquainted with fundamentals of mathematics, chemistry and pharmacognosy.
Teaching methods
Classes and single-bench practicals.
Teaching Resources
Course slides available on Ariel website
Handout for laboratory practicals
Recommended textbooks
Assessment methods and Criteria
The final examination involves a written and an oral test, the latter accessed after the former has been passed. The written test comprises 2/3 questions on general topics covered in the course (time available about 50 minutes, outcome of the written test and schedule of the oral one notified in a few days). The oral test comprises a minimum of 3 questions on more specific topics. The final score is expressed out of thirty.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 16 hours
Lessons: 40 hours
Professor(s)
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71