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DissolvIt® is a unique instrument for in vitro dissolution- and absorption testing of inhalation drugs, making it very simple to generate PK profiles of test substances and relate them to their listed reference drugs with a simple, precise, automated process; an important process for generic drug companies. Per Gerde, Chief Scientific Officer at, and founder of, Inhalation Sciences tells how he came about the idea and what the challenges were in realizing this unique instrument.
Q: Per, what is your “explain to grandma” description of DissolvIt®?
A: DissolvIt® is designed to mimic the conditions in the lungs where inhaled particles are deposited on the mucus in the lungs, followed by their dissolution- and absorption into the blood circulation. DissolvIt® is a simple concept reflecting the real physiological process: the inhalation drug is aerosolized with PreciseInhale® and the particles are deposited on glass elements, which are then transferred to the DissolvIt®, and there contacted with the artificial lung/blood barrier consisting of a mucus layer on one side of a porous membrane, with a blood simulant flowing past the other side. This assembly reproduces the physiological process of how the drug is dissolved and absorbed in the lungs, before reaching the systemic circulation.
DissolvIt® has an automatic fraction collector to sample the blood simulant in single-pass mode, allowing the possibility of creating PK-like curves with simulated key parameters such as Cmax and tmax just like PK curves obtained in vivo in preclinical- or clinical studies.
Q: Per, how did you come about the idea of DissolvIt®?
A: There are no established, standardized methods for in vitro dissolution tests of inhaled drugs. The current methods most frequently used are derived from technologies which were designed for oral solid drugs decades ago, like the “paddle over disk” and Transwell methods.
This leads to a variety of disparate data sets that are hard to compare internally and with corresponding in vivo data; a frustration we shared with a world leading pharmaceutical giants with whom we engaged in a collaboration for the development of the DissolvIt®.
Q: What was the most difficult part in realizing DissolvIt®?
A: We invested quite some energy and time in finding the most physiologic membrane and mucus simulant alternatives. The guiding principle has been that when multiple paths in terms of similarity to in vivo data were obtained, the simpler choice won. We have several publications with the results of our research on core properties of the DissolvIt®.
Q: What about the level of evidence available?
A: In establishing a new methodology it is absolutely key to have solid evidence, so we have a number of published articles in peer-reviewed journals as a strong foundation of the data DissolvIt® can generate and we also started a dialog with regulatory authorities.
Q: Who is using DissolvIt® today?
A: We have performed PK studies with DissolvIt® for more than 10 years in numerous contract projects within Inhalation Research Services, where we conduct research on account of numerous clients in our lab in Stockholm.
Nonetheless, we now have DissolvIt® installed and ordered in several continents: North America, Europe and Asia.
DissolvIt® is perfect for comparing in a quick and accurate way the PK profiles of different formulations, offering already at the in vitro stage important information on how the formulations will behave following inhalation in vivo.
It is an ideal tool for generic companies to compare test drugs and reference ones, but also for early drug discovery to compare the PK profiles of different drug candidates.
Q: What can Inhalation Sciences do for generic drug companies in general?
A: Inhalation Sciences’ approach is precision and accuracy in the frame of a physiologic approach. At the end of the day researchers need to simulate and predict how substances will behave in humans, so a more physiologic approach and accuracy in dealing with inhalation drugs will lead to better decisions at an early stage for drug developers, be it generics or new drug entities.
