Syllabus
1. Introduction to the training program and its specifics, general description and new trends in the pharmaceutical industry
2. Physico-chemical properties of active active substances, BCS classification, absorption, distribution, metabolism, elimination and toxicity
3. Intellectual property: why and what to patent, what are the rules and strategies in the pharmaceutical industry
4. Search for solid forms of active substance, their mutual relations, selection of solid form of active substance on the basis of physico-chemical properties
5. Reverse engineering - analysis of the original dosage form using various analytical techniques (XRPD, Raman microscopy, SEM, ssNMR, MRI, etc.)
6. Formulation processes: description and comparison of individual formulation processes used in the pharmaceutical industry
7. Characterization of the dosage form according to specification I: creation of specification and overview of identification tests (IR, NMR, MS, XRPD - examples) and methods of classical analyzes (water content, sulphated ash, selected titrations - examples)8. Characterization of the dosage form according to specification II - separation methods: focus on HPLC chromatography (content, purity, development of the method and its validation); GC (determination of solvents), electrophoresis
9. Characterization of the dosage form according to specification III - dissolution methods according to specification and their "non-standard" use
10. Clinical testing: what are the possibilities of clinical testing, how to set up a clinical study correctly, what needs to be fulfilled
11. Optimization of formulation processes during enlargement to an industrial scale
12. Product registration (strategy, rules and preparation of documentation)
Annotation
Within the course "Development of a medicinal product", students will get acquainted with the whole process of drug form development - from characterization and selection of the active substance, formulation processes, clinical testing to the launch of the medicinal product. Individual lectures will be designed from the explanation of the theory to demonstrations on real examples from pharmaceutical practice. It will be shown how to apply knowledge of analytical, organic and physical chemistry together with the basics of chemical engineering and biochemistry in drug development. Individual lectures will be presented by experts from the pharmaceutical company Zentiva
After completing the course, the student will be able to:
- Explain the physicochemical properties of active pharmaceutical ingredients.
- Describe the processes of absorption, distribution, metabolism, elimination, and toxicity.
- Determine BCS classification.
- Clarify the reasons for patenting in the pharmaceutical industry.
- Identify the relationships between different solid forms of active ingredients.
- Evaluate the application of analytical techniques in reverse engineering.
- Describe various formulation processes in the pharmaceutical industry.
- Describe classical analysis methods and separation techniques.
- Propose procedures for optimizing formulation processes when scaling up to industrial scale.
- Evaluate and prepare essential parameters for clinical testing.
- Explain the strategies, rules, and procedures for the registration of a medicinal product.