SubjectsSubjects(version: 877)
Course, academic year 2020/2021
  
Industrial drug product development - N409087
Title: Vývoj léčivého přípravku v praxi
Guaranteed by: Department of Chemical Engineering (409)
Actual: from 2019
Semester: winter
Points: winter s.:2
E-Credits: winter s.:2
Examination process: winter s.:
Hours per week, examination: winter s.:1/1 C+Ex [hours/week]
Capacity: unlimited / unlimited (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Level:  
For type:  
Note: course can be enrolled in outside the study plan
Guarantor: Beránek Josef Ing. Ph.D.
Šoóš Miroslav prof. Ing. Ph.D.
Annotation -
Last update: Kubová Petra Ing. (13.08.2018)
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.
Aim of the course -
Last update: Kubová Petra Ing. (13.08.2018)

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.

Syllabus -
Last update: Kubová Petra Ing. (13.08.2018)

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 physic-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. Formulation processes 1a: Description and comparison of various formulation techniques

9. Formulation processes 1b: Description and comparison of various formulation techniques

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

11. Formulation processes 2: how to select suitable formulation process and excipients, troubles in developing various products, parameter optimization during scale-up

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

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

Short internship (one week) in Zentiva

 
VŠCHT Praha