Learning Outcomes
Upon successful completion of the course, students are expected to:
- be introduced to the general concepts of pharmaceuticals, in the process of discovery and development of drugs
-they will learn about Scaling up production in the pharmaceutical industry, the industrial production of medicines, the rules of good manufacturing practice, quality control in a pharmaceutical industry.
- to learn about the basic pharmaceutical formulations in which medicines are available
- to familiarize themselves with the presentation of a topic related to the subject
- to understand connection of the laboratory with the industrial scale
- to conduct laboratories on the production of pharmaceuticals and connect theory with practice
The aim is to introduce students to the interesting field of the bio-pharmaceutical industry and drug quality control and to determine the position of the chemical engineer in it. The subject has been adapted to the directions and level of postgraduate studies and provides the foundations, but also the stimulus and motivation for students who want to specialize further or within the framework of a doctoral thesis in medicines(discovery and development).
Course Content (Syllabus)
Introduction. Basic terms and definitions
Drug Discovery and Development process
Innovation in the Pharmaceutical Industry
New (innovative) drugs - Generic drugs -Biosimilars
Drug properties: solubility-particle size
Intro to Pharmacokinetics
Pharmacodynamics – Bioavailability-Bioequivalence
Analysis of pharmaceuticals
Quality control of Pharmaceuticals – Good manufacturing practices- Pharmaceutical Quality by Design (QbD)
Scale up in the pharmaceutical industry: from lab to industrial production -Case studies
Scale up vs scale-out, Single Use technologies – Spatial planning of the pharmaceutical industry (Negative/positive pressure rooms, gowning/degowning, personnel and material flow)
Pharmaceutical process development
The drug manufacturing process
Tablet-Capsules-Ointments-Creams -Emulsions-Suspensions
Drug Delivery - Diffusion and Dissolution of Drugs
Stability – Shelf life of pharmaceuticals
Laboratory: extraction methods, production of ointments-creams