PHARMACEUTICAL MANUFACTURING
Learning outcomes of the course unit
The course want to provide an introduction to the classic processes of the manufacturing of pharmaceuticals with a special attention devoted to the aspects that can be considered critical for the quality of the medicinal product.
Prerequisites
Students are required to take the exam of Pharmaceutical Technology before presenting themselves to the exam of Industrial Manufacturing of Medicines.
Course contents summary
The course will treat arguments of industrial production of medicines, starting from the industrial organization to the description of the unit operations for dosage forms manufacturing and medicines preparation. Detailled description of operations and dosage forms manufacturing will be done. The knowledge functional to the understanding of the processes linked to the medicines preparation is devoted to the attainment of high quality pharmaceutical products.
Course contents
- Structure and organization of pharmaceutical plants
- Good manufacturing practice
- Validation
- Water for pharmaceutical productions
- Drying
- Mixing of liquids
- Mixing of powders
- Filtration
- Milling
- Tabletting
- Capsules Manufacturing
- Manufacturing of sterile dosage forms
- Packaging
Recommended readings
L. Fabris A. Rigamonti
LA FABBRICAZIONE INDUSTRIALE DEI MEDICINALI
Societa’ Editrice Esculapio, Ed 2008
P.Colombo, P.L.Catellani, A.Gazzaniga, E.Menegatti, E.Vidale
Principi di tecnologie farmaceutiche.
Editore: Casa Editrice Ambrosiana, 2015
Teaching methods
The teaching method is frontal didactics. Special care is addressed to the teacher/student interaction. The participation to the lessons is compulsory.
Assessment methods and criteria
As an optional opportunity of evaluation, to students attending the lesson is proposed an evaluation of the semester learning through written test at the end of the teaching of each module. The test consists in multiple choice questionnaire.
In alternative an evaluation via oral examination is also possible at the exam sessions.
Other informations
The teacher is available for questions on Tuesday, Wednesday and Thursday, before and after the lesson time.
