Nebulised Drug Product Development Services

We have been supporting clients’ product development for over 30 years across all classes of inhaled and nasal delivery technologies including nebulized therapeutics. We provide expert OINDP formulation development, product performance testing and analysis, in vitro bioequivalence studies, stability, product characterisation studies, design verification studies, device/excipient compatibility studies, comparator studies, CMC support for NDAs/ANDAs, and clinical manufacturing services.

We conduct test programs with a focus on critical test parameters for nebulisers such as droplet size, the delivered dose, the viscosity of the drug and how the drug is absorbed by the lungs. Our stability team are experienced in designing and delivering robust stability studies with consistent aerosol testing methods which are critical to ensure a stable and safe product.

As the delivery efficiency is closely connected to the nebuliser technology, our experienced team can support your product development to help ensure the formulation is compatible for a specific nebuliser technology. For example, some devices may not be suitable for delivery of biological drugs such as proteins, peptide, or oligonucleotides as different technologies can introduce oxidative, sheer or heat stresses which may lead to decomposition, aggregation, or other degradation pathways and hence loss of activity.