Risk Assessment of Multiple Extractables from Components of an MDI

Metered Dose Inhalers (MDIs) are manufactured from a variety of plastic or rubber materials, and over time leaching into the active substance can occur. We undertook a risk assessment to estimate risk to human health from exposure to the MDI leachables.

Metered Dose Inhalers (MDIs) comprise of many components relating to the mechanics of the delivery system. These components are invariably manufactured from plastic or rubber materials from which there is considerable choice to the device manufacturer. Some of these components come into contact with the active substance being delivered and over time leaching into the active substance can occur. Therefore leachates from device components can be administered via normal inhalatory actuations by the end user. Appropriate safety and risk assessments have to be conducted on any new component being used in such devices. wca have considerable experience in the detection and identification of appropriate toxicological data from which safe levels can be determined and compared with the product specifications and human exposure scenarios in order to estimate risk to human health from exposure to the MDI leachables.