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.
“Who controls the past controls the future: who controls the present controls the past.”
– George Orwell –
First outlined by Joseph M. Juran, quality-by-design (QbD) suggests continuous improvement and feedback loops in drug manufacturing. Biopredictice tools play a key role in the development of medicines by implementing prior knowledge into the development pipeline. TheWackerLab specializes in key areas of formulation development
Nanomedicine is applied as a delivery platform for a wide variety of drugs and administration routes. The complexities in their design and manufacture require a better understanding of attributes relevant for the in vivo performance. Recent examples include liposomal generics such as Talidox but also the delivery of peptides, proteins, or mRNA. To synthesize nanomedicines we are using scalable and GMP compliant microfluidic technologies.
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. Focusing on oral and injectable drug delivery systems, we predict the performance based on in vitro data. This is how we gain better control of the formulation properties during early development.
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 toxicological effects of nanomedicines. The transition of the drug from the bounded to the un-bounded state is captured in the blood concentration-time profile. To identify the impact of drug release and degradation on the bioavailability of drugs in animals or humans, we apply in silico modeling techniques and smart data analysis. By accessing the preclinical and clinical data using state-of-the-art analytical techniques, we learn from the experiences of the past.
Building bridges between the past and the future, we identify relevant physiological processes affecting the in vivo absorption and establish validated in vitro-in vivo correlations (IVIVCs). These IVIVCs provide ultimate proof for the predictive power of our in vitro assays and can be used to estimate the pharmacokinetics of novel drug delivery systems.