Drug delivery developers must simulate device drops; EMA

- Last updated on GMT

Related tags: Food and drug administration, European medicines agency

Drug delivery developers must simulate device drops; EMA
The EMA is advising manufacturers to simulate dropping a drug delivery device during development to test its robustness. 

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 Last year the US Food and Drug Administration (FDA) posted draft guidance​ that said companies must make sure patients “understand critical device limitations…or the need to maintain the device​.”

Related news

Show more

Related products

show more

A Better Approach, for Better Pain Trials

A Better Approach, for Better Pain Trials

Signant Health | 27-Sep-2021 | Technical / White Paper

Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more