PHARMACEUTICAL MANUFACTURING
cod. 1004486

Academic year 2016/17
4° year of course - First semester
Professor
Academic discipline
Farmaceutico tecnologico applicativo (CHIM/09)
Field
Discipline chimiche, farmaceutiche e tecnologiche
Type of training activity
Characterising
40 hours
of face-to-face activities
5 credits
hub: PARMA
course unit
in ITALIAN

Learning objectives

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 unit content

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 and understanding of the processes linked to the medicines preparation is pivotal for making judgments over the necessary steps to be taken to obtain high quality pharmaceutical products.

Full programme

- 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

Bibliography

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 with the intervention of professionals from the pharmaceutical industry. 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 information

The teacher is available for questions on Thursday, before and after the lesson time.