Today, many drug molecules exhibit poor aqueous solubility and bioavailability. There is a need for innovative formulation approaches to improve their performance in drug therapy. Smart drug delivery systems require advanced analytical technology to assure their quality and safety but also to predict the clinical outcomes at an early stage in drug development.
“Quality planning consists of developing the products and processes required to meet customer’s needs”
– Joseph M. Juran –
Following a quality-by-design approach our group combines novel formulation technologies with highly advanced drug release models to identify critical quality attributes of drug delivery systems.
Drug release testing
The drug release rate is an important characteristic associated with medical therapeutics and it influences the rate and extent of the availability of the active pharmaceutical ingredient to the body. To measure this important characteristic our team developed the dispersion releaser technology which is capable of measuring the dissolution rate of nanomedicines.
In contrast to nanomedicines, drug molecules often escape from blood circulation or pass physiological barriers such as the gastrointestinal wall or the blood-brain barrier. They are responsible for the therapeutic and the toxicological effects. The transition from the bound to the unbounded state is captured in the clinical data or, to be more specific, in the pharmacokinetic profile. To identify the role of drug release in a clinical setting, we apply in silico modeling and compartmentalise the human body into different areas of accumulation. This provides a time-resolved roadmap of the movement and distribution of nanomedicines and the drug molecules in the human body.
Predicting clinical performance
Although the drug release profile is only a single component in this rather complex mosaic, it can be used to predict the clinical performance of nanomedicines. The drug release rate measured in the laboratory can be correlated to accurately predict the actual drug release profile in the human body or even a specific patient population.