According to Inhalation Sciences (ISAB), the FDA will provide up to $500,000 over two years to fund a study intended to validate ISAB’s DissolvIt in vitro lung simulation model for dissolution testing of inhaled drugs. The company said that the agency’s National Center for Toxicological Research has approved the research proposal, and the study is expected to begin within a few months.
The goal of the study, ISAB said, is to show DissolvIt’s ability to demonstrate in vitro in vivo correlation (IVIVC) and bioequivalence as a step toward attaining an FDA recommendation of DissolvIt as a standard research tool. The DissolvIt module works with ISAB’s PreciseInhale dosing system to simulate dissolution and absorption of dry powder formulations in the lung and produces Cmax and Tmax curves as well as full aerosol characterization.
ISAB CEO Manoush Masarrat commented, “We would like to thank the FDA’s National Center for Toxicological Research for what is without doubt one of the most important strategic milestones in our company’s history. FDA-endorsement of DissolvIt would truly be historic, opening up new major markets and enabling ISAB technology to play a key role in setting even better benchmarks for the predictability, efficacy and ultimately safety of new inhaled therapies. This is a truly transformative opportunity and we are delighted to proceed in collaboration with the FDA.”
Read the Inhalation Sciences press release.
