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(Stockholm, 17 January 2022) Inhalation Sciences (ISAB) has submitted a white paper to the US FDA (Food and Drug Administration) aiming to validate its in vitro simulated lung model DissolvIt[®] as an FDA-recommended technology, and, ultimately, a new standard research method for inhaled drug research in the US. If approved, the FDA will co-fund the project for up to 250 KUSD (approx. 2.2 MSEK) on an annual basis for up to two years. A final decision on approval for the submitted whitepaper is expected in September 2022.
Inhalation Sciences has submitted a formal whitepaper to the FDA's National Center for Toxicological Research following months of discussions on how DissolvIt[® ]could further improve research and outcomes for inhaled drugs. The research project aims to make DissolvIt[®], ISAB's in vitro simulated lung model, FDA-recommended - and ultimately to validate it as a recommended standard research method to be extensively used in inhaled drug development.
The FDA's National Center for Toxicological Research funds a range of research projects, prioritizing those that "spur the development of new regulatory approaches that can help improve predictability" and "replace, reduce and/or refine animal testing" [(1)] .These are all defining characteristic of DissolvIt[®], ISAB's advanced simulated lung model that produces simulated in vitro dissolution / absorption data that closely predicts in vivo data, with no animal testing involved. Such in vitro in vivo correlated data (IVIVC data) significantly reduce risk and cost in the early stages of inhaled drug development, as well as improving the safety and precision of inhaled therapies.
With papers such as "In Vitro to ex Vivo/In Vivo Correlation (IVIVC) of dissolution kinetics from inhaled particulate solutes using air/blood barrier models" published in the Journal of Aerosol Science [(2) ]in 2021, DissolvIt[®] has been increasingly recognized as a leading solution in in vitro lung data for its ability to mimic the physiology of the lung and generate voluminous clinical-like data.
In the DissolvIt[® ]project described in the submitted white paper to FDA, DissolvIt[® ]will be evaluated by matching test formulations against reference formulations using a wide range of substances spanning from fast- to slow-dissolving APIs. The goal is to evaluate the ability of DissolvIt[®] to detect small formulation differences and evaluate in vitro to in vivo correlation as well as bioequivalence.
ISAB CEO Manoush Masarrat: "FDA's clear commitment to innovative technologies that can help set better benchmarks for the predictability, efficacy and ultimately safety of new therapies is hugely inspiring. We are convinced that DissolvIt[®] can play an important role within inhalation research. Official endorsement from the FDA would be transformative - for us, for the industry but also, ultimately, for inhalation patients. We are proud to have summited this white paper and looking forward to receiving the feedback from FDA in the coming months. Without doubt the opportunity to collaborate with the FDA would be historic for us and of course for DissolvIt[®]."
1. https://www.fda.gov/science-research/about-science-research-fda
2. https://www.sciencedirect.com/science/article/pii/S002185022030183X