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.

 

#Performance Testing

The performance of drug products depends on a wide variety of parameters such as the drug release or the physical stability of the delivery system. Our team develops novel performance assays. The dispersion releaser (DR) technology was one of our first inventions and has been commercialized by Pharma Test. In our efforts we focus on the peroral and injectable drug delivery systems.

 

#Pharmacometrics and Modelling

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 of nanomedicines. The transition from of the drug from the bounded to the unbounded state is captured in the blood concentration-time profile. To identify the impact of drug release and degradation on bioavailability of drugs in animals or humans, we apply in silico modeling techniques and smart algorithms.

 

#IVIVC

To improve drug therapy, we must continously refine our delivery strategies. Release testing enables prediction of the in vivo performance of nanomedicines. As a result, biopredictive in vitro and in silico methods contribute to the rational design of formulation prototypes in the early stage of drug development and bring us closer to a quality-by-design approach.

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