The preciseinhale story
At the Lovelace Respiratory Research Institute (LRRI), in the 1990s Swedish inhalation pioneer Dr. Per Gerde faced a problem: He needed an aerosol generator sophisticated enough to validate his model predictions on radioactive diesel dust dosimetry in the lungs, using just a speck of study material. Such a system did not exist. So Dr. Gerde began building it.
Today, PreciseInhale is the most versatile precision dosing research platform in the inhalation field.
While working as a visiting scientist at LRRI, the elite US research organization dedicated to respiratory disease, Dr. Per Gerde faced a problem: He needed an aerosol generator sophisticated, and of a high enough quality, to validate theoretical model predictions on radioactive diesel dust dosimetry in the lungs.
He knew the system had to be able to generate an aerosol so fine and with such even lung distribution that it would deliver high-quality data, with low standard deviation and minimum particle agglomeration – from the smallest amounts of powder. Furthermore, he wanted a range of exposure modes: not just nose-only or intratracheal, but both – as well as the potential for other modalities too.
Such a system did not exist. In fact, to Dr Gerde’s surprise, pulmonary aerosol research technology in the early 90s was still relying heavily on basic technologies, like the Wright Dust Feeder, originally developed and patented in the 1950s.
So, equipped with a strong background in pharmacokinetic modeling, Dr. Gerde began building the new system. Fifteen years and several patents later, PreciseInhale is the most versatile aerosol and inhalation drug development platform in the world, with some at the recent DDL (Drug Delivery to the Lungs) conference in Edinburgh (December 11-13, 2013) hailing it as ‘a game changer’ in an expanding, dynamic market.
Precision dosing: Increased control, improved results
The next-generation platform has broken from previous pulmonary aerosol research technologies in key ways, evolving into a multi-exposure platform offering pulmonary researchers world-class data, using dry powder or inhalers, from a range of modalities – in vitro, isolated perfused lung, in vivo, nose-only or intratracheal – all the way from preclinical to clinical research.
“I really enjoyed the can-do attitude at the Lovelace Institute,” says Dr Gerde. “It was here that I broke with conventional dry powder technologies, creating the two essential innovations that set PreciseInhale apart: First – precision, controlled, active dosing, made possible by separating the process of aerosol exposure into its two consecutive steps – aerosol generation and aerosol dispensing.”
Unlike conventional aerosol generators this allows the high energy released during aerosolization to be separated from the exposures of delicate lungs, making for finer, more evenly distributed aerosols in the airways. With classic instillation technologies, the test powder can be released in one focused blast or as a liquid bolus; where particles are often not dispersed finely enough. The procedure can be tough on the animal’s lungs, resulting in uneven lung distribution, lower quality data and, potentially, unwanted lung lesions..
“From the beginning we knew we wanted active, precision dosing. Unlike all other inhalation technologies for dry powders we concentrated on the inhaled dose – measured by computer – not merely the aerosol concentration entering the animal’s breathing zones. PreciseInhale is the only platform where you can customize and set the dose exactly – before you begin the tests,” says Dr Gerde.
In the second prototype of PreciseInhale, developed on his return to Sweden, Dr Gerde changed the mechanics of the system to computer-controlled, pneumatic valves, resulting in a smoother and gentler operation.
World-class computer data results
Central to the success of precision dosing is PreciseInhale’s impressive computer interface. From the first prototype of PreciseInhale in 1998 Dr Gerde has worked closely with inhalation IT expert CO Sjöberg. Sjöberg, a member of the Association of Inhalation Toxicologists, specializes in using the intuitive, innovative software tool LabVIEW for a variety of inhalation applications.
“Calle designed and set up the process-control of Astra Zeneca’s inhalation facilities,” says Dr Gerde. “His superb medtech IT expertise has been vital to the usability and efficiency of PreciseInhale. The results and data displays we can generate are excellent; the precision and pre-metered dosing we achieve with PreciseInhale is all thanks to Calle’s computerization of the system. We both worked from the principle that you measure and save almost all possible data – because you never know when you’ll need them.”
Quality not quantity: Individual dosing
Another key area of innovation is PreciseInhale’s focus on gathering high-quality data from single animals’ exposures, rather than relying on lower-quality data from larger groups of simultaneously exposed animals, or, common during larger-scale operations, using multiple-port inhalation towers.
How did this come about?
“In conventional inhalation labs,” says Dr Gerde. “Researchers would sometimes talk about tough exposure days, where anything from 12 to 60 rats were put into a nose-only tower where they all had to be simultaneously exposed, and then simultaneously investigated post-exposure –under often stressful conditions. It is actually a false economy, with an uneven work-flow in the lab and a lot of test substance consumed, and it still only achieves lower-quality data, so slowing down the research. If you compare the data generated from tower-exposures with the data we generate from precision dosing of individual subjects, you can see single dosing is way more efficient, cost efficient and a time saver. With PreciseInhale you can choose your Candidate Drugs earlier on before entering into regulatory bodies. We have had teams in the lab using our system rather than conventional tower exposures – and they have ended up preferring it.”
PreciseInhale, 15 years in development, is now emerging as not just another system but a game changer, a total inhalation lab – compact on your workbench – with the potential to fundamentally change how most companies and institutes carry out inhalation and aerosol research.
With its recent US patent confirmed, first sales rolling out and a host of corporate research projects taking place using PreciseInhale modalities, 2014 looks set to be a breakthrough year for the technology.
Read more here: