Meeting aerosol delivery standards from mesh micropump nebulizers for a test item formulated in ultrapure water - A case study

AIT 2023 -- Initial technical trials delivering an oligonucleotide test material formulated into ultrapure water using a partner-designated clinical mesh micropump delivery platform identified two nebulizer performance challenges that were each capable of limiting the required nonclinical program. The partner had been working with the nebulizer manufacturer to obtain sufficiently reliable delivery within the scope of the clinical program, but while able to generate the test item with high efficiency for required clinical periods of generation, the selected platform was subject to frequent delivery failures. Each occasion of stoppage required attending staff to either repeatedly intervene by tapping the reservoir, to invert the unit while tapping it until generation resumed or to manually clean the aerosol outlet spigot. Mesh micropump aerosol generation was considered essential to the delivery of the intact oligonucleotide to the respiratory tract.