INDUSTRIAL PHARMACEUTICAL TECHNOLOGY
TECNOLOGIA FARMACEUTICA INDUSTRIALE
INDUSTRIAL PHARMACEUTICAL TECHNOLOGY
TECNOLOGIA FARMACEUTICA INDUSTRIALE
| A.Y. | Credits |
|---|---|
| 2015/2016 | 6 |
| Lecturer | Office hours for students | |
|---|---|---|
| Roberta Censi |
Assigned to the Degree Course
| Date | Time | Classroom / Location |
|---|
Learning Objectives
To acquire knowledge on:
- The industrial production of the pharmaceutical dosage forms: study of the productive processes of oral topical and parenteral dosage forms
- Advanced delivery systems for the targeting and release of biotechnological drugs
- The pharmaceutical production plant: study of the internal organization of a pharmaceutical industry
- The pharmaceutical legislation and regulation: GMP, FDA, ICH etc...
Program
The industrial process technologies:
The pulverization
The blending
The production of tablets
The granulation
The pelletization
The drying processes
The production of capsules
The coating
The production of parenteral forms
Water for Injection (WFI)
The sterilization
The freeze drying
The clean rooms for the production of injectable forms
Blow-Fill-Seal
The production of innovative formulations of biotech drugs:
The production and formulation of biotechnological drugs
The polymeric conjugates
Gene therapy formulations
The production of innovative formulations for biotechnological drugs:
The production of biotech drugs
The polymeric conjugates
Gene therapy formulations
Advanced formulations for pharmaceutical proteins: hydrogels, microparticles, nanoparticles, liposomes
The pharmaceutical industry:
The industrial organization
The pharmaceutical directives
The quality system and the Good Manufacturing Practice
The validation process
The industrial development of a drug
The technology transfer
The AIC
Hygiene and cleanliness standards in the pharmaceutical industry
Air treatment units
The ICH
Bridging Courses
Module of "Preparation and Control of Pharmaceuticals"
Learning Achievements (Dublin Descriptors)
Students will acquire knowledge and expertise on the main challenges the pharmaceutical industry is confronted with, during the large scale preparation of pharmaceuticals with innovative and profitable industrial processes. The course is directed to the training of professionals able to solve and approach technological issues that may be encountered during the fabrication and quality control of the main dosage forms. Students will have an overview of the skills and expertise required for employees of all departments of the pharmaceutical industry.
Teaching Material
The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it
Supporting Activities
None
Teaching, Attendance, Course Books and Assessment
- Teaching
Lectures
- Attendance
None
- Course books
1. P. Colombo et al. "Principi di Tecnologie Farmaceutiche" Ambrosiana Ed.
2. Ceschel, G.C., Fabris, L., Lencioni, E., Rigamonti, S. IMPIANTI PER
L'INDUSTRIA FARMACEUTICA. Società Editrice Esculapio, Bologna, 1982
3. Lachman L., Lieberman H., Kanig J. The theory and practice of industrial pharmacy, Ed. Lea & Febiger, USA
- Assessment
Oral Exam
- Disabilità e DSA
Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.
A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.
Additional Information for Non-Attending Students
- Teaching
Lectures
- Attendance
None
- Course books
1. P. Colombo et al. "Principi di Tecnologie Farmaceutiche" Ambrosiana Ed.
2. Ceschel, G.C., Fabris, L., Lencioni, E., Rigamonti, S. IMPIANTI PER
L'INDUSTRIA FARMACEUTICA. Società Editrice Esculapio, Bologna, 1982
3. Lachman L., Lieberman H., Kanig J. The theory and practice of industrial pharmacy, Ed. Lea & Febiger, USA
- Assessment
Oral exam
- Disabilità e DSA
Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.
A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.
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