Growing interest in unique in vitro capabilities at Aerosol Society Symposium
ISAB technology was featured by two presenters during the Aerosol Society Symposium on Bioequivalence in London, Monday March 30. One used a full, graphic image of the PreciseInhale system to illustrate the growing sophistication of inhalation R&D testing. “I saw increased awareness of the growing capabilities of in vitro testing, and its crucial role in In vitro–In vivo Correlation (IV-IVC) at the Symposium,” says ISAB Product Development Manager for in vitro Studies Maria Börjel. “The 80 professionals attending, from all around the world, were united in understanding the growing urgency around bioequivalence and IV-IVC.”
ISAB founder Dr Per Gerde and Maria Börjel attended the intensive one-day symposium Bioequivalence of Orally Inhaled Drug Products at the National Heart and Lung Institute, Imperial College, Kensington, London on Monday March 30. Darragh Murnane from the University of Hertfordshire and Robert Price from the University of Bath organized the symposium. Generic and novel inhaled pharma companies including GSK, Aeropharm, Chiesi, Hovione, Prosonix and Vectura all attended, among others.
In vitro PK: Unique to ISAB’s DissolvIt
At the Symposium Börjel noted a sharp increase in the interest around in vitro testing and a raised awareness of its capabilities: “I believe peoples’ perspective on in vitro testing is broadening,” she says. ”The great attendance reflects growing appreciation of the increased value of in vitro testing, and how much comparative in vitro data adds. Many colleagues from around the industry had heard of DissolvIt, our in vitro dissolution/absorption simulation and PK profiling module. It was encouraging and exciting. The kind of in vitro testing we carry out on DissolvIt goes way further than the more classical in vitro testing, such as particle size distribution and static stirred beaker tests. Our in vitro testing includes a PK profile with Tmax and Cmax curves, delivering powerful predictability, and crucial go / no go data.”
Regulatory interest in IV-IVC growing
Börjel predicts that more companies will begin to look deeper into in vitro data as regulatory interest in bioequivalence grows. “European law is sympathetic to the accelerated development of generic inhaled products and values in vitro bioequivalent data highly,” she says. “No other in vitro system out there mimics the in vivo behavior of inhaled particles in the lungs as closely, or delivers in vitro data as accurate as DissolvIt.”
What have DissolvIt clients said?
“This is the most sophisticated and well-thought-out in vitro system I’ve ever seen. The system replicates the mucus layer on the lung and is thermostatted at 37?C. The chemistry is excellently engineered, and all the medical insights are right. Everything is measured and characterized carefully.”