Nebulised Drug Product Development Services

Nebulised drug development expertise with a focus on formulation development, product performance testing, in vitro bioequivalence studies, stability, product characterisation, design verification studies, device/excipient compatibility studies, comparator studies and CMC support for NDAs/ANDAs

Nebulizers provide a proven and effective solution for delivering aqueous suspension and solution formulations to the lung. While pMDI and DPI devices have their own advantages, especially concerning patient experience, nebulization as a route for drug delivery offers a rapid pathway into the clinic for new chemical entities as well as a highly transferable option for high value therapeutics including biopharmaceuticals.

Nebulisers operate by atomising the drug liquid formulation into fine droplets for inhalation, suitable for both solution and suspension formulations. Performance of the nebuliser can be selected and tailored by utilising a range of technologies and designs to work in parallel to the formulation design to optimise aerodynamic droplet size and drug delivery. A strategic drug product development approach is required to maximise efficiency, reproducibility, and consistency.

Common types of nebulisers include jet nebulisers, vibrating mesh nebulizers, and ultrasonic nebulisers. Newer developments in device technologies can deliver far greater efficiency and speed of dosing, addressing some of the historic issues associated with drug product stability. This delivery route provides an effective solution for the delivery of proteins and other complex biopharmaceuticals.

Nebuliser Development Expertise
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. As an independent development partner, we have experience working with a wide range of manufacturers and devices.

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.

Your Nebulized Drug Development Partner
From early-stage development, through to in-process control and product release assays, our scientists are here to help you reach your milestones. Our nebuliser product development programs, integrated with analytical testing and stability studies, can help you to determine if your drug product delivers consistent and effective performance in line with the target product profile, maintaining performance throughout the product lifetime.

Our vision is to make the world a better and safer place and our aim is to be the world’s most trusted partner for Quality Assurance. Intertek’s innovation-led, end-to-end Total Quality Assurance (‘TQA’) proposition helps organisations operate safely, effectively and with complete peace of mind in an increasingly complex, fast-changing world.