Master in Medicinal and Biopharmaceutical Chemistry

Drug Stability

ECTS

5

Learning outcomes

Drug stability is a core topic in the advanced training for those targeting a career in the pharmaceutical companies and custom research organizations (CROs). It integrates knowledge from organic and physical chemistry, as well as from regulatory sciences.

At the end of this course, the student should:
- Predict the main routes of decomposition of a drug knowing the functional groups in the molecule, using a mechanistic approach.
- Understand the chemical kinetics principles and their application in the context of stability of drugs.

- Recognize and analyse problems related to the stability of compounds and propose strategies to solve these problems.
- Be able to design studies to determine the intrinsic reactivity of compounds in different aqueous media and pH values.
- Be able to analyse the experimental data to determine the half-life and re-test period of active ingredients.
- know how to plan stability study protocols during development of a medicament.

Syllabus

- Study of stability in the drug development process.
- Major degradation pathways of drugs in solution and in the solid state.
- Detailed analysis of the essential principles of chemical kinetics to study drug stability.
- Experimental methods and validation.
- Regulatory aspects of the stability studies.
- Designing stability study protocols during development of a medicament.

In tutorial classes the theoretical concepts will be applied by solving exercises that illustrate the drug decomposition mechanisms and kinetic data analysis for determining catalytic parameters, pH-rate profiles, activation energy, in order to propose drug and prodrugs decomposition
mechanisms. In addition, presentation and discussion of case studies will be implemented. This will include the presentation of stability studies in the context of the regulatory agencies and in the context of a pharmaceutical company.

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