Clinical pharmacokinetics and biopharmacy

The biopharmacy focuses on the relationships between the fate of the drug in the body, the time course of drug action and intensity and the physico-chemical properties of the drug as well as the dosage form. The evaluation needs the pharmacokinetic interpretation of processes in the body (drug absorption, distribution, metabolism and excretion) as well as qualitative and quantitative description of the time course changes.
During the practical training students perform tasks using in vitro and in vivo methods and bioanalytical procedures. Furthermore they learn the mathematical calculations of pharmacokinetic parameters and computer simulations.

Lecture topics

1. Evolution and significance of biopharmacy.
2. Basic concepts. Terms and definitions. Pharmacokinetic models and parameters I.
3. Fate of drug in the body. The LADME-model.
4. Drug release. The Biopharmaceutical Classification System.
5. Transport processes and absorption mechanisms. Factors influencing the absorbtion.
6. Pharmacokinetic models and parameters II. Single and multiple administration.
7. Metabolism and its biopharmaceutical aspects. Importance of Bioanalysis.
8. Excretion processes.
9. Methods of pharmacokinetic analysis. Compartment, non-compartment analysis and other approaches.
10. Bioavailability and bioequivalence. Importance of food interaction.
11. Pharmacokinetic investigations during drug research and development.
12. Biopharmaceutical and pharmacokinetic studies, in vitro-in vivo correlations.

Practice topics

1. Introduction.
2. The distribution of salicylic acid in a three-phase system. The influence of surface active agent on the transport.
3. Dissolution rate determination using rotating basket method in the case of Diclofenac-ratiopharm tablet (50 mg) and Voltaren retard tablet (100 mg).
4. Study on in vitro drug release from ointments with local effect. Penetration study from semisolid preparation in Franz cell like apparatus.
5. Release of diclofenac from patch.
6. The extraction and assay of diclofenac sodium from synovial fluid.
7. Urinary excretion of ASA after rectal administration.
8. Determination of theophylline plasma levels in beagle dogs after iv. administration.
9. Determination of theophylline plasma levels in beagle dogs after oral administration.
10. Pharmacokinetic calculations.
11. Computer Aided Learning.
12. Consultation.