New pre-separator removes coarse lactose particles for more lifelike particle size distribution
Our new pre-separator removes coarse lactose particles larger than 5 µm before they reach PreciseInhale’s main holding chamber. The pre-separator aims for a 50% cut-off at 5 µm, essentially removing all particles 10 µm and above from the test aerosol, so our in vitro testing module should mimic in vivo processes even more closely, delivering a particle size distribution closer to that which actually occurs in the lungs of patients using inhalers.
We’re running tests on the new impactor now. Early results are promising. Coarse-grained carrier lactose, dusted with finer drug particles on the outside, is used in testing to impact in the throat upon sudden inhalation, so releasing some of the finer drug particles that continue down into the lungs. The pre-separator mimics this, retaining the larger particles in a manner similar to that which happens in the throat.
When DissolvIt, our in vitro simulation system, receives a test aerosol it will now be similar in particle size to that which enters the lungs in patients using inhalers with drug formulations containing coarse lactose.
The pre-separator contains an impactor stage of precision engineered holes that speed up and direct air streams with the test powder at the inner walls of the cylindrical separator. The hole arrangement of the impactor can be exchanged to separate the right size of particles for the inhaler being tested – whatever the flow rate prescribed. We’ve developed the new pre-separator in response to client requests.