SubjectsSubjects(version: 912)
Course, academic year 2022/2023
  
Advanced Development Methods of Pharmaceutical Products and Processes - P409015
Title: Pokročilé metody vývoje farmaceutických produktů a procesů
Guaranteed by: Department of Chemical Engineering (409)
Faculty: Faculty of Chemical Engineering
Actual: from 2022 to 2022
Semester: both
Points: 0
E-Credits: 0
Examination process:
Hours per week, examination: 3/0, other [HT]
Capacity: winter:unknown / unknown (unknown)
summer:unknown / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Level:  
For type: doctoral
Note: course is intended for doctoral students only
can be fulfilled in the future
you can enroll for the course in winter and in summer semester
Guarantor: Beránek Josef Ing. Ph.D.
Is interchangeable with: AP409015
Annotation -
Last update: Cibulková Jana Ing. (28.07.2022)
Lectures will be led by scientists and experts from the pharmaceutical company. Students will become familiar with current trends in drug product development. Lectures will encompass characterization and selection of active molecule, formulation processes, clinical testing and launch to marketplace. Students will work in groups – as a development team – to design and develop a drug product. Students will apply their knowledge from analytical, organic and physical chemistry, chemical engineering and biochemistry.
Aim of the course -
Last update: Cibulková Jana Ing. (28.07.2022)

Students will understand the complexity of drug product development. They will gain knowledge through real-life case studies in intellectual property protection, solid state chemistry (selection and characterization of solid state forms), dissolution testing, formulation processes, clinical testing and drug product registration.

Literature -
Last update: Řehák Karel doc. Ing. CSc. (23.11.2022)

Multiparticulate Drug Delivery, Formulation, Processing and Manufacturing, Springer New York NY, 2017, ISBN 978-1-4939-7010-0.

Biopharmaceutics, from fundamentals to industrial practice, John Wiley and Sons Ltd, USA, 2022, ISBN 978-1-119-67828-1.

Syllabus -
Last update: Cibulková Jana Ing. (28.07.2022)

1. Class overview and goals to be reached, introduction of the program and lecturers, new trends in pharma industry

2. Physico-chemical properties of active pharmaceutical ingredients (API), BCS classification, drug absorption, distribution, metabolism, elimination and toxicity

3. API solid state screening, relationships among solid forms of API, crystallization

4. Intellectual property: What to patent and why? Rules and strategies in pharma industry

5. API solid form selection based on physico-chemical properties (solid form stability/conversion, chemical stability, solubility)

6. Reverse engineering - analysis of reference drug product using a number of analytical approaches (X-ray powder diffraction, Raman microscopy, Scanning electron microscopy, solid state nuclear magnetic resonance)

7. Characterization of drug product 1: non-standard analytical approaches, dissolution and stress testing

8. How to select suitable formulation process and excipients, chemical sensitivity and compatibility

9. Formulation processes 1a: Challenges in drug product development

10. Formulation processes 1b: Challenges in drug product development

11. Formulation processes 2: Parameter optimization during scale-up

12. Characterization of drug product 2: what needs to be analyzed to comply with required limits (drug product specification, method development and validation)

13. Clinical testing: what are the options, what needs to be done, how to select and set-up clinical study

14. What needs to be done after successfully completed clinical program, scale-up to industrial scale, drug product registration

Entry requirements -
Last update: Cibulková Jana Ing. (28.07.2022)

Basic knowledge of organic chemistry, physical chemistry, analytical chemistry, chemical engineering, biochemistry

Registration requirements -
Last update: Cibulková Jana Ing. (28.07.2022)
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