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.
The knowledge and understanding acquired will focus on the organisation of the pharmaceutical industry and the manufacturing of medicines.
At the end of the course the student will be able to understand the process of manufacturing and of introduction to the market of the medicinal products.
The teaching approach will push the student towards the development of a critical opinion (making judgements) and of communication skills of the knowledge acquired that will be fostered by the use of professional experts along with in itinere assessments. This will stimulate the student to use new studying tools and methods, developing a new set of learning skills.
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 focus on aspects related to the industrial manufacturing of medicines, starting from the organization of pharmaceutical companies to the description of the single operations required for dosage forms manufacturing. A detailed description of operations and dosage forms manufacturing will be done through the use of case studies and the contribution of experienced professionals that will be invited to share their knowledge with the students. 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.
Professionals from pharmaceutical companies will be invited to give specialistic lectures. This will offer to the students educational material up-to-date and to access knowledge closely connected to the requirements of the pharmaceutical industry.
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 (MCQ) 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.
