Pharmaceutical Stability Studies

Data

Official data in SubjectManager for the following academic year: 2023-2024

Topic

Based on the previously acquired knowledge of pharmaceutical chemistry and pharmaceutical technology, the course material provides an overview of the international system of requirements for drug stability tests, and the requirements for performing and evaluating the tests. Based on the test results of specific pharmaceutical compounds and pharmaceutical preparations, it describes the chemical and physico-chemical bases of the decomposition processes of pharmaceutical compounds. It provides an explanation of the nature of the most common chemical incompatibilities and their consequences and describes the possible technological methods of preventing them.

Lectures

• 1. Concept and importance of drug stability. Physical, chemical, microbiological, therapeutic and toxicological stability. International requirements systems for stability tests. - Dr. Perjési Pál
• 2. Concept and importance of drug stability. Physical, chemical, microbiological, therapeutic and toxicological stability. International requirements systems for stability tests. - Dr. Perjési Pál
• 3. Stability indicator test methods and their validation I - Dr. Perjési Pál
• 4. Stability indicator test methods and their validation II - Dr. Perjési Pál
• 5. Stability indicator test methods and their validation II. - Dr. Perjési Pál
• 6. Stability indicator test methods and their validation II. - Dr. Perjési Pál
• 7. Decomposition-specific stability studies. Evaluation of the test results. - Dr. Perjési Pál
• 8. Decomposition-specific stability studies. Evaluation of the test results. - Dr. Perjési Pál
• 9. Drug decompositions occuring in the liquid phase. Decomposition reaction orders. Correlation between the chemical structure and stability of pharmaceutical compounds. - Dr. Perjési Pál
• 10. Drug decompositions occurring in the liquid phase. Decomposition reaction orders. Correlation between the chemical structure and stability of pharmaceutical compounds. - Dr. Perjési Pál
• 11. Correlation between the chemical structure and stability of pharmaceutical compounds. - Dr. Perjési Pál
• 12. Correlation between the chemical structure and stability of pharmaceutical compounds. - Dr. Perjési Pál
• 13. Solid phase decomposition mechanisms. Decomposition kinetics of solid pharmaceutical preparations. Midsemester test I. - Dr. Perjési Pál
• 14. Solid phase decomposition mechanisms. Decomposition kinetics of solid pharmaceutical preparations. Midsemester test I. - Dr. Perjési Pál
• 15. Predictive kinetic determination of expiration time - Dr. Perjési Pál
• 16. 16. Predictive kinetic determination of expiration time. - Dr. Perjési Pál
• 17. Basic concepts of photochemistry. The influence of light on the rate of decomposition reactions. - Dr. Perjési Pál
• 18. 18. Basic concepts of photochemistry. The influence of light on the rate of decomposition reactions. - Dr. Perjési Pál
• 19. Decompositions based on oxidation-reduction. Antioxidants. - Dr. Perjési Pál - Dr. Perjési Pál
• 20. Decompositions based on oxidation-reduction. Antioxidants. - Dr. Perjési Pál - Dr. Perjési Pál
• 21. Transformations based on hydrolysis. The role of pH in hydrolytic reactions. Midsemester test II. - Dr. Perjési Pál
• 22. Transformations based on hydrolysis. The role of pH in hydrolytic reactions. Midsemester test II. - Dr. Perjési Pál
• 23. Stability of optically active compounds. Spatial structural changes. Other chemical decomposition processes. - Dr. Perjési Pál
• 24. Stability of optically active compounds. Spatial structural changes. Other chemical decomposition processes. - Dr. Perjési Pál

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Handouts.

Notes

Recommended literature

Kenneth A. Connors, Gordon L. Amidon, Valentino J. Stella
Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists 2nd Edition
Wiley-Interscience, 1986

Conditions for acceptance of the semester

Maximum of 15 % absence allowed

Mid-term exams

During the semester (weeks 7 and 12), students write two mandatory written papers, which are evaluated using a percentage rating. At least one of the papers written must be graded at 60%, and the average of the papers written must be at least 50%. It is possible to write a remedial paper in the 13th week. The result of the paper is added to the results of previously written papers.

Making up for missed classes

It is not possible to make up missed lectures.

Exam topics/questions

N/A

Examiners

Instructor / tutor of practices and seminars