Dropping an inhalation device during development allows the manufacturer and European Medicines Agency (EMA) to see how it performs after the wear and tear patients may inflict in the real world.
“The product performance should be investigated under conditions to simulate use by patients. Simulation of dropping the delivery device and the robustness of any lockout mechanism should be investigated,” the EMA wrote in an update to its drug quality question and answer document.
Biopharma developers are advised to drop the device late in its life cycle, for example after using 180 of the 200-doses. Waiting until late in the device’s life allows developers to see the effect a possible dislodging of drug accumulated on the mouthpiece or other part of the system has on performance.
For devices that are designed to have the mouthpiece removed for cleaning the developer should run two separate tests. In the first the mouthpiece is removed and cleaned as per the instructions. For the second developers should drop a device they have never cleaned.
After dropping the device developers should test performance. “Significant variations in the delivered dose or fine particle mass should be fully discussed in terms of the safety and efficacy of the product,” the EMA wrote.
Handle with care
Developers are also advised to assess the impact of less extreme day-to-day use of the inhaled drug delivery device by carrying the system between doses and using it as often as the instructions say.
Data generated through these tests should shape the handling instructions manufacturers write for patients. Giving clear handling instructions is one way to increase the likelihood dosing is consistent.
Regulators are increasingly interested in human factors affecting devices and how they alter dosing. Last year the US Food and Drug Administration (FDA) posted draft guidance that said companies must make sure patients “understand critical device limitations…or the need to maintain the device.”