Industrial Pharmaceutical Technology – Elective Subject

The subject is recommended for the students interested in several fields of industrial pharmaceutical technology such as research and development of new dosage forms and medicinal preparations. The course focuses on: the history of industrial pharmacy, profiles of the pharmaceutical industry, career for pharmacists; pharmaceutical technological aspects of product authorization; evolution of dosage forms; innovation and intellectual property; preformulation and formulation studies; optimization of dosage form composition; control of active substance and excipients, physic-chemical and solid state characterization; novel drug delivery systems; design of the manufacturing process. Critical formulation attributes and process parameters; comparison of scaling-up methods.

Lecture topics (7. semester):

1. The significance of the pharmaceutical industry.
2. The evolution of the pharmaceutical industry. Structure, characteristics.
3. Pharmacists in the pharmaceutical industry.
4. Technological aspects of the quality for the approval of medicinal preparations.
5. Pharmaceutical development.
6. Innovation and Intellectual Property.
7. Intellectual property aspects of pharmaceutical technology I.
8. Intellectual property aspects of pharmaceutical technology II.
9. Formulation design.
10. Manufacturing processes and unit operations.
11. Design of drug delivery systems.
12. The quality of the drug and excipients.
13. Optimisation and scale-up general methods.
14. Summary Overview of consultation.

Lecture topics (8. semester):

1. Introduction to the pharmaceutical manufacturing processes.
2. The main characteristics of the pharmaceutical manufacturing.
3. The evolution of manufacturing processes.
4. Dosage form development and production.
5. Drug delivery systems I.
6. Drug delivery systems II: Nanocarriers.
7. Quality aspects of production.
8. In-process control.
9. Process Analytical Technology.
10. Non-destructive analytical tests.
11. Dosage form design and Quality by Design.
12. Pharmaceutical excipients and special formulations.
13. Biotechnological products.
14. Validation and statistical process control. Summary review.